Standards For Maternal and Neonatal Care - WHO

2007
I ntroducti on
Standards
for Maternal and
Neonatal Care
What are the Standards for Maternal and Neonatal Care?
The Standards for Maternal and Neonatal Care consists of a set of user-friendly leafets
that present World Health Organization (WHO) key recommendations on the delivery of
maternal and neonatal care in health facilities, starting from the frst level of care. Facilities
at higher levels of care should also have these standards in place as a minimum (essential)
care for all mothers and babies; in addition, they should have standards for the care of
women and newborns in need of obstetric and special care. The Standards for Maternal and
Neonatal Care are part of the WHO Integrated Management of Pregnancy and Childbirth
Care (IMPAC) Package, which provides guidance for assisting countries to improve the
health and survival of women and their newborn babies during pregnancy, childbirth and
the postnatal period.
Why implement the Standards for Maternal and Neonatal Care?
Studies clearly indicate that countries with high maternal, perinatal and neonatal mortality
have inadequate and poor quality health services and this can be associated with reduced
utilization of health care services. As such, increased emphasis is being placed on the need
for standards of care, as well as mechanisms which address the barriers to provision and
use of quality care. Evidence also suggests that explicit, evidence-based guidelines improve
the process and outcomes of health care when appropriately implemented. Experience
from countries indicates that the characteristics of the guidelines, the process used in their
development and a clear implementation strategy supported by effective monitoring and
supervision infuence the impact of practice guidelines.
What is the purpose of the Standards for Maternal and Neonatal Care?
The purpose of the Standards for Maternal and Neonatal Care is to assist programme
managers and health care providers to:
develop evidence-based national and sub-national standards on maternal and neonatal
health care;
introduce standards setting and a quality improvement process at facility level as a
means to improve access and quality of maternal and neonatal health services;
provide effective maternal and neonatal health services;
use existing resources to achieve the optimal health care outcomes; and
improve individuals', families' and community's satisfaction and utilization of maternal
and neonatal health services.
How are the Standards for Maternal and Neonatal Care structured?
Overall the Standards for Maternal and Neonatal Care include the most relevant topics that
need to be addressed for ensuring quality maternal and neonatal health services. They
are grouped in six sections: fve sections focus on clinical standards, where as the sixth
encompasses health service delivery standards that are crucial to ensure the provision of
quality maternal and neonatal care.
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I ntroducti on Standards
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The Standards for Maternal and Neonatal Care currently comprise the following sections:
General standards of care for healthy pregnancy and childbirth
Standards for safe care in childbirth and the immediate postpartum period
Standards for postnatal care
Standards of care for managing major complications in pregnancy, childbirth and after
birth
Standards of care for managing major complications in the newborn
Health service delivery standards
How is each of the Standards for Maternal and Neonatal Care structured?
While presented in a package, each standard is structured to be self-standing, complete with
all the elements needed for implementation. This format is meant to facilitate country use
by encouraging a stepwise implementation of the standards according to country needs
and availability of resources. In addition, such a format should allow for more effective
updating. The section on effcacy and effectiveness of the proposed recommendations in
each of the standards will be periodically updated as new evidence is gathered.
The key elements common to all standards are:
the title, which identifes the standard;
the standard statement, which is based on the best available evidence, feasibility and
cost effectiveness;
the aim, which indicates the public health intent and goal of implementing the
standard;
a section titled requirements, which indicates a checklist form the conditions that need
to be in place to implement the standard;
a section called applying the standard, which briefy explains what the health provider
(for the frst fve sections) or the health manager (for the section on health service
delivery standards) must do to implement the standard;
a section focusing on audit, with suggested input, process and outcome indicators to
be used to monitor the correct implementation and impact of the standard;
a narrative part called rationale, which comprises two sections, namely the burden of
suffering of the condition that the standard addresses, and the effcacy and effectiveness
section which describes the importance of the recommendations and the evidence in
support of the standard;
a table of evidence, which summarizes the most important results of the available
evidence;
a list of references used to develop the standard; and
a list of links and additional readings, which will assist the users in implementing the
standards.
How were the Standards for Maternal and Neonatal Care developed?
In order to appropriately refect the diversity of expert opinion and disciplinary perspectives,
a systematic, participatory process was used in the development of these standards, in
accordance with WHO Guidelines for Guidelines (http://whqlibdoc.who.int/hq/2003/
EIP_GPE_EQC_2003_1.pdf ). Draft standards were developed by WHO technical staff in
the Making Pregnancy Safer (MPS) Department and the Department of Reproductive Health
and Research. These drafts were then shared with other relevant departments for ensuring
technical accuracy and consistency with other WHO programmes, and with WHO Regional
Offces and MPS country focal persons, to gather input on their applicability in different
contexts. Additional inputs have been requested from external experts and institutions
throughout the entire development process.
3 I ntroducti on Standards
Levels of evidence
1++ High quality meta analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias
1+ Well conducted meta analyses, systematic reviews of RCTs, or RCTs with a low risk of bias
1 - Meta analyses, systematic reviews of RCTs, or RCTs with a high risk of bias
2++ High quality systematic reviews of case-control or cohort studies
High quality case-control or cohort studies with a very low risk of confounding, bias, or chance and a
high probability that the relationship is causal
2+ Well conducted case control or cohort studies with a low risk of confounding, bias, or chance and a
moderate probability that the relationship is causal
2 - Case control or cohort studies with a high risk of confounding, bias, or chance and a signifcant risk that
the relationship is not causal
3 Non-analytic studies, e.g. case reports, case series
4 Expert opinion
The standards which are included in this guideline are only limited to those for which
there is extensive experience or scientifc evidence to support the recommendation. Three
guiding principles were used in the selection of the topics:
1. public health relevance, as major causes of maternal, fetal or neonatal mortality and/or
morbidity;
2. feasibility of implementation at frst level facilities in settings with limited resources,
both from the health service delivery and community perspective;
3. cost implications, such as cost-effectiveness (where information was available).
To develop the standards, a systematic process and methodology for gathering and
summarizing the evidence was developed. The search for evidence followed a sequential
process, beginning with higher level evidence, and including observational studies
whenever hard evidence (randomized controlled trials or systematic reviews) were not
available. For the Clinical Standards the following sources were used: Medline, Embase, and
Cinhal (Silverplatter platform), the Cochrane Library, Medline and the WHO Reproductive
Health Library, WHO publications based on technical working groups and expert reviews,
and a number of articles and websites based on reference lists review and WHO guidelines.
For the Health Service Delivery Standards the search included: PubMed, Sciencedirect,
EconLit, Interscience, Popline, IDEA, and ECONbase, as well as the databases of relevant
organizations, departments, and institutions, such as the World Health Organization,
World Bank, Save the children and others as identifed by the standards development sub-
group.
A table summarizing the evidence complements each standard by presenting the analysis
of the studies retrieved, their quality, the population considered in the studies including
the specifc baseline risk and an estimate of the effcacy of the intervention for major
outcomes (benefts and harms). The level of evidence presented in the clinical standards
is based on the SIGN methodology which uses a scale from 1 to 4 as shown in the table
below.
Given the nature of the Health Service Delivery Standards, the studies mostly fell in
categories 3 and 4. Therefore, the decision was made by the technical consultation team
to use an alternative system scale for this group of standards. The scale is rated from 1 to
5 (1 = not very relevant and 5 = very relevant evidence as it relates to the standard). Each
standard is completed by a list of references used in its development and a list of links
and additional readings which can be used to facilitate the implementation and auditing
process.
These standards were developed under the overall guidance of a Steering Group which
has overseen the work of a Development Advisory Group, organized in three sub-groups
on maternal, neonatal and health service delivery issues respectively. The development
process included extensive consultations with relevant WHO departments (including Child
and Adolescent Health and Development; Stop TB; Roll Back Malaria; HIV/AIDS, Nutrition
I ntroducti on Standards
4
for Health and Development; Immunization, Vaccines and Biologicals; Essential Drugs and
Medicines Policy; Essential Health Technologies; Health Systems Policy and Operations;
and Human Resources for Health), WHO Regional Offces, professional organizations
(International Confederation of Midwives and International Federation of Gynaecology
and Obstetrics), the UNFPA, and experts and individuals from developing as well as
developed countries.
For which audience are the Standards for Maternal and Neonatal Care
intended?
The Standards for Maternal and Neonatal Care should be of interest to:
policy-makers;
programme managers and health planners at national, district and facility levels,
maternal and neonatal health professionals;
NGOs, including private sector health organizations, involved or interested in the
provision of maternal and neonatal health services; and
community organizations interested in improving maternal and neonatal health care
practices.
Given the differences between countries in relation to the categories of health workers
providing maternal and neonatal care, and rather than measure on a specifc health care
cadre, this document focuses more on the skills and services required to ensure that
maternal and neonatal ill health conditions are possibly prevented and properly identifed
and managed. For the majority of cases and particularly in relation to routine maternal
and neonatal care, the health care provider with these skills will better correspond to
the skilled attendant
*
. However, it must be considered that a proportion of women and
babies might require specialized care and consequently knowledge and skills of health
care providers that are beyond those of the skilled attendant and that are not covered by
this document.
How can the Standards for Maternal and Neonatal Care be utilized?
The Standards for Maternal and Neonatal Care are intended to be generic standards, which
can be adapted and implemented according to the needs, fnancial and health systems
capacities in different countries. They can be used individually or as a package. They are
cross-referenced with each other for ease of use.
The standards can be used at the national and sub-national level to establish or to update
current norms in line with the latest available evidence. Ideally, most of these standards
should be in place to ensure quality maternal and neonatal health services. However,
country users may wish to implement them in a stepwise manner (incrementally), for
example, beginning with implementation only a few at one time, and then gradually
scaling up to implement additional standards.
The standards can serve to further develop guidelines as well as design training curricula
for the skilled attendants and other health care providers of maternal and neonatal care.
They can also be used in the adaptation process of the Pregnancy Childbirth Postpartum
and Newborn Care practice guide, the Manual for Complications in Pregnancy and Childbirth,
the Manual for Newborn Problems, and other relevant WHO guidelines.
*
The term skilled attendant in the document refers exclusively to people with midwifery skills (for example midwives,
doctors and nurses) who have been trained to profciency in skills necessary to manage normal births and diagnose, manage
or refer obstetric and neonatal complications. Skilled attendants may practice in hospitals, clinics, health units, homes, or in any
other service setting. Skilled attendants must be registered and/or legally licensed to practise. (Making Pregnancy Safer: the
critical role of the skilled attendant. A joint statement by WHO, ICM and FIGO. Geneva 2004)
5 I ntroducti on Standards
At the facility level, the Standards for Maternal and Neonatal Care can represent a useful tool for
facilitating a systematic approach to evaluate and improve the care provided by maternal and
neonatal health services. They can be the vehicle for introducing clinical audits which are the
systematic review of the quality of care based on standards of care agreed upon by all the relevant
health providers, or focus on a broader quality improvement process within the health facility.
It is envisaged that the process of setting standards, using standards to audit clinical practice and
implementing agreed changes will contribute to improving providers performance and clinical
practice. It is intended that the Standards for Maternal and Neonatal Care will assist to enhance
both health providers and managers awareness of quality of care and of their role to ensure best
practices in communities with maternal and neonatal health services.
The WHO Making Pregnancy Safer Department intends to assist countries in adapting and
implementing the Standards for Maternal and Neonatal Care as one of the key MPS strategies
to infuence policy decisions and improve health service provision towards the reduction of
maternal and neonatal mortality and morbidity, thus contributing to the achievement of MDG4
and MDG5.
The Standards for Maternal and Neonatal Care will be updated as scientifc evidence and experience
in their use accumulates and will be modifed to support the implementation of better maternal
and neonatal services in countries.
Devel opment
Process
Standards
for Maternal and
Neonatal Care
1. Introduction
In accordance with WHOs mandate and comparative advantage, the Department of Making
Pregnancy Safer (MPS) has developed generic standards for maternal and neonatal care,
with the purpose of providing countries and the international community with a tool for
establishing evidence-based national standards of care. Where appropriate, MPS will assist
countries and partners to develop and implement their own standards based on this generic
tool. This work is one of the strategies to improve health service provision for women
and newborn babies and complements other Integrated Management of Pregnancy and
Childbirth (IMPAC) clinical and managerial tools.
2. Process
2.1 Overall process
In order to appropriately reect the diversity of expert opinion and disciplinary
perspectives, a systematic consultative process was used in the development of these
standards. A Steering Commiee and a Standards Development Advisory Group were
established, whose composition and functions are described in Section 3. Dras standards
were developed internally by the technical sta in MPS in consultation with additional
experts from the Department of Reproductive Health and Research (RHR) and experts
external to WHO. These dras were then shared with other relevant departments, including
Child and Adolescent Health and Development (CAH); Stop TB; Global Malaria Programme
(GMP); HIV/AIDS; Nutrition for Health and Development (NHD); Immunization, Vaccines
and Biologicals (IVB); Technical Cooperation for Essential Drugs and Traditional Medicine
(HTP/TCM); Essential Health Technologies; Health Policy, Development and Services (HDS);
and Human Resources for Health (HRH) for ensuring technical accuracy and consistency
with other WHO programmes. Starting from their early development stage the dras were
also shared with WHO Regional o ces and Making Pregnancy Safer country focal points,
to gather input on their applicability in dierent contexts. Additional inputs have been
requested from external experts and institutions throughout the entire development process.
The Clinical Standards were reviewed in a technical consultation in Geneva,14-16 October
2002, where as the Health Service Delivery Standards were reviewed in a technical
consultation in Geneva, 26-28 October 2004.
2.2 Methodology
In the selection of the list of topics for the standards, the following principles have been
used:
public health relevance as a major cause of maternal, fetal or neonatal mortality and/or
morbidity;
feasibility of implementation at rst level facilities in seings with limited resources,
both from the health service delivery and community perspective;
cost implications, such as cost-eectiveness (where information was available).
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Devel opment process Standards
2
Aer having agreed on the standards' framework and having dened the list of standards
based on established guiding principles, the following process was applied for the development
of each standard:
Renement of the questions to be addressed in each standard.
Undertaking of a systematic review, critically appraise, synthesize and grade the
evidence. All evidence, including that on safety, to be clearly laid out in an evidence
table. Meta-analysis to be done when the data permied.
Development of model standard recommendations, including criteria for the
implementation of the standard and suggested indicators for audit, and description of
the application in dierent scenarios.
Peer review held by widely circulating the standard to experts, professional
organizations, regional o ces and target audiences in countries.
Dissemination plans made, including plans for contextualisation and evaluation, within
an agreed standard seing framework.
Completion of documentation of the standard development process.
Submission to the Steering Group for reviewed approval of dra version, a well as to the
Director of the Department for nal approval.
2.3 Source of evidence
To develop the standards, a systematic process and methodology for gathering and
summarizing the evidence was developed. The search for evidence followed a sequential
process, beginning from higher level evidence (systematic review, randomized controlled
trials) and included observational studies whenever randomized controlled trials or systematic
reviews were not available.
The basic search strategy was developed using the National Library of Medicine medical
Subject Headings (MeSH) key word nomenclature developed for each of the databases used.
The initial search was performed in The Cochrane Library using the identied term both as a
MeSH and as a free term. Clinical evidence was always consulted as a second step to update the
Cochrane search results. When insu cient evidence was found, a further step was designed to
search in MEDLINE (and then to duplicate the search in EMBASE and CINHAL). Selection was
limited to human subjects. No time limits were applied. Three dierent specic search lters, as
developed by Scoish Intercollegiate Guidelines Network (SIGN), were used to progressively
identify Systematic review and Metanalysis, Randomized Controlled Trial and all other studies.
The lters are more sensitive and less specic than the ones developed and used by the
Cochrane Collaboration. For the purpose of our search higher sensitivity was preferred; and a
second phase based on hand selection of all the studies retrieved was successively performed.
Finally, a free search was performed in Tripdatabase to identify any further important article.
When the same authors or group of authors published more than one article on the same topic
and with the same conclusion, the most recent one was reported. Relevant studies not selected
through the lters but known by the standards development group or identied among the
references of other studies were also included
In summary, for the Clinical Standards, the following sources were used: Medline, Embase,
and Cinhal (Silverplaer platform), The Cochrane Library, and the WHO Reproductive Health
Library, WHO publications based on technical working groups and expert reviews, and a
number of articles and websites based on the review of references lists and WHO guidelines.
In addition, for the Health Service Delivery Standards the search included: PubMed,
Sciencedirect, EconLit, Interscience, Popline, IDEA, and ECONbase, as well as the databases of
relevant organizations, departments, and institutions, such as the World Health Organization,
the World Bank, Save the Children and others as identied by the standards development sub-
group.
3 Devel opment process Standards
2.4 Presenting the evidence
The evidence in support of the standards is presented in three ways: a narrative section
named e cacy and eectiveness, which describes the importance of the recommendations and
the evidence in support of the specic standard; a list of references; and a table of evidence,
which summarized the most relevant articles, their quality, the population considered in the
studies, including the population specic baseline risk and an estimate of the e cacy of the
intervention for major outcomes (benets and harms).
Study (Type
& Level of
evidence)
Population &
Seing
Objective &
Intervention
Outcomes
linked for the
Standard
Results Comments
Prendville
2003
Most recent
substantive
amendment
March 2000
Systematic
review
1++
6477 women.
5 studies, 3 in
UK 1 in Ireland,
1 in United
Arab Emirates.
In three studies
only low risk
women.
All maternity
hospitals.
Baseline risk=11-
14%
To assess
the eects of
active* versus
expectant**
management of
the III stage of
labour.
Moderate PPH
Severe PPH
Blood
transfusion
Active vs. Expectant Two out of ve
studies included
are not clear
about the three
components
included
in active
management
All women
NNT 12 (10-14)
4 studies
6284 women
3616 women
NNT 57 (41-89)
4 studies
6284 women
NNT 65 (47-
106)
5 studies
4 studies
Low risk
women
11 (9-14)
3 studies
3616
women
88 (51-306)
3 studies
women
3616
women
74 (49-147)
4 studies
3809
women
To facilitate the interpretation of the evidence, the identied articles relevant for the
standard contents were tabulated as follows:
In the rst column, we indicated the author and publication year, the Study type and
level of evidence. Level of evidence assignment is based on SIGN methodology. In case
of a systematic review from The Cochrane Library, we report the year of most recent
substantive amendment.
In the second column, we described the Study population and seing. We decided to have
this specic column to give as much information as possible on population and seing
of the considered studies (if possible, the baseline risk of the condition under study in
the given population is reported), to allow comparison and proper decision making
since the standard will be used in dierent seings and with dierent health priorities
(external validity of the studies retrieved and reproducibility).
The third column reports Objectives and Intervention as described in the study.
In the fourth column, Outcomes relevant for the standard are selected. In some cases,
(especially when reporting the results of a systematic review), the reported outcomes
are not the whole set of outcomes under study; and as a consequence the population for
the specic outcome can dier from the one presented in the systematic review. Number
of studies and specic population for the outcome selected are therefore reported in the
next column, under Results.
*Active management of the third stage of labour, which is here dened as the package of interventions comprising:
(i) administration of a prophylactic oxytocic with or immediately after delivery of the baby and usually;
(ii) early cord clamping and cutting (only in two studies); and
(iii) controlled cord traction to deliver the placenta.
**Expectant management of the third stage of labour which is here dened as a hands off policy, where signs of separation are awaited and the placenta
allowed to deliver spontaneously or with the aid of gravity or nipple stimulation. The components of active management described above are not routinely
employed.
4
The h column reports Results for each of the selected outcomes. We decided to
present the results, whenever possible and adequate, as Number Needed to Treat
(NNT) and/or Number Needed to Harm (NNH), with 95% CI, since this will enable
policy-makers to choose whether to introduce the intervention in their programmes and
make recommendations as part of the localization process of the standard.
Comments on the importance and relevant aspects of each study with respect to the
standard revised are nally presented in the last column.
The level of evidence presented in the clinical standards is based on the SIGN methodology which
uses a scale from 1 to 4 as shown in the table below.
Levels of evidence
1++ High quality meta analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias
1+ Well conducted meta analyses, systematic reviews of RCTs, or RCTs with a low risk of bias
1 - Meta analyses, systematic reviews of RCTs, or RCTs with a high risk of bias
2++ High quality systematic reviews of case-control or cohort studies
High quality case-control or cohort studies with a very low risk of confounding, bias, or
chance and a high probability that the relationship is causal
2+ Well conducted case control or cohort studies with a low risk of confounding, bias, or chance
and a moderate probability that the relationship is causal
2 - Case-control or cohort studies with a high risk of confounding, bias, or chance and a
signicant risk that the relationship is not causal
3 Non-analytic studies, e.g. case reports, case series
4 Expert opinion
Given the nature of the Health Service Delivery Standards, the studies related to health
service delivery issues mostly fell in categories 3 and 4. Therefore, the decision was made
by the technical consultation in October 2004 to use an alternative system scale for this
group of standards. The scale is rated from 1 to 5 (1 = not very relevant and 5 = very relevant
evidence as it relates to standard). Each standard is completed by a list of references used
in its development and a list of links and additional readings which can be used to facilitate
the implementation and auditing process.
3. Organizational structure, roles and responsibilities
The development of the Standards for Maternal and Neonatal Care (SMNC) was guided by
an overall Steering Commiee, composed mainly by WHO sta, who gave direction to and
had responsibility for the entire process from development to implementation. A technical
Standards Development Advisory Group, composed by WHO sta and external experts from
dierent elds, was also established with the responsibility of developing the standards
and provide advice on technical issues. This group was organized in three main subgroups,
focusing on maternal, neonatal and health service delivery issues respectively. While the
main responsibility of each subgroup was to develop the standards related to their area of
expertise, members of the other subgroups were also acting as advisory body for the review
of the standards developed by the other subgroups. Whenever necessary, the Standards
Development Advisory Group was complemented by Technical Resource Persons who were
identied within WHO or externally to provide technical inputs on specic issues, and
the formulation of Task Forces to undertake systematic reviews of the evidence or conduct
consultation with experts if evidence was lacking.
Finally, managerial and administrative support was provided by WHO secretariat.
3.1 SMNC Steering Committee
The Steering Commiee was an in-house group composed of WHO technical experts with
the general function of overseeing each step of the development process of the standards.
3.1.1 Functions
The Steering Commiee was charged with the following functions:
Dene the general parameters of the SMNC.
Dra broad guidelines for the Standards Development Advisory Group (SDAG),
subgroups and appropriate task forces.
Select the chair and members of the SDAG and task forces.
Orient the SDAG to the specic TOR and the process of development of the SMNC.
Regularly monitor the development of the SMNC.
Ensure all processes are in place to comply with the WHO guidelines for guidelines
(hp://whqlibdoc.who.int/hq/2003/EIP_GPE_EQC_2003_1.pdf
Ensure a rigorous external review of each of the standards.
Review the nal dra of the standards for approval by the Assistant Director-General
of the Family and Community Health Cluster in WHO.
3.1.2 Composition
Chair: Paul Van Look, Director Reproductive Health and Research Department (RHR)
Coordinator: Ornella Linceo, Medical O cer, Making Pregnancy Safer Department
(MPS)
Members: 6 persons from within the MPS team who together had the following skills
and expertise:
a) Expertise in guidelines development and evidence-based methodologies
b) Familiarity with implementation of programmes in developing countries in the area
related to the SMNC
c) Knowledge of the subject /topic/content of the guideline, such as midwifery
services and training (Della Sherra), Obstetric Care (Luc de Bernis and Rita
Kabra), Neonatal Care (Ornella Linceo), Health Service Delivery (Helga Fogstad),
and Health Promotion (Annie Portela).
At least 1 member from outside the MPS team who has expertise in developing
evidence based guidelines (Nicola Magrini, Director of CeVEAS Centre for
evaluation of eectiveness of health care)
3.2 Standards Development Advisory Group (SDAG)
The Standards Development Advisory Group was a large multidisciplinary group,
organized in three subgroups according to three main areas of work: maternal
(coordinated by Della Sherra), neonatal (coordinated by Ornella Linceo) and health
delivery system (coordinated by Helga Fogstad), with the responsibility of developing the
SMNC, in-line with guidance from the Steering Commiee.
3.2.1 Functions
Dene the specic issues to be addressed by each of the standards.
Provide technical advice on topics/areas on which additional expertise is required.
Undertake a systematic search for evidence.
Review the evidence available.
Develop recommendations linked to the strength of the evidence.
Dra and review the standards.
Discuss and incorporate, where relevant, comments of external reviewers.
Dra the nal version of standards.
6
Make recommendations on standards seing process and dissemination strategy.
Document the process of guideline development.
3.2.2 Composition
Coordinators: Della Sherra, Ornella Linceo and Helga Fogstad
Criteria for selection of the coordinators:
- Be credible and command respect in the eld/subject area.
- Have experience in guideline development.
- Expert in the eld of Maternal and Neonatal or Health System for MNH.
8-12 members representing multidisciplinary background, including:
- Professionals (experts in maternal or neonatal health and health systems);
- Methodologists; and
- Stakeholders.
At least 1 member from each of the Regional Ofces (MPS regional coordinators):
- MPS Coordinator AFRO, Seipati Mothebesoane-Anoh;
- MPS Coordinator AMRO, Vicky Camacho;
- MPS Coordinator EMRO, Ramez Mahaini;
- MPS Coordinator EURO, Alberta Bacci;
- MPS Coordinator SEARO, Ardi Kaptiningsih; and
- MPS Coordinator WPRO, Ruyan Pang/Khine Sabai La.
At least 1 member from each of the Regional O ces as it relates to MNH health system
issues:
- Head of Reproductive and Child Services, Ministry of Health, Tanzania, representing
AFRO, Catherine Sanga;
- Head of Womens Health Program Ministry of Health, Chile, representing AMRO, Rene
Castro;
- Health Care Delivery Regional Adviser, representing EMRO, Ahmed Abdel Latif;
- Health Systems Expert, Switzerland, representing EURO, Gelmius Siupsinskas;
- Nursing and Midwifery Regional Adviser, representing SEARO, Duangvadee
Sungkhobol; and
- Health Systems, Maternal and Child Medical Research Centre, Mongolia, representing
WPRO, Dashzeveg Natsuvd.
All external technical advisers were asked to sign a declaration of interest form (aached
as Annex 1).
3.3 SMNC Technical Resource Persons
There were additional resource persons either within WHO or externally, who were identied
by the Steering Commiee and/or SDAG to provide technical input on specic issues.
3.3.1 Functions
Provide input on specic technical issues as requested by the SDAG or Steering
Commiee.
Partake in technical discussions with SDAG and Steering Commiee.
Review specic parts of the dra document and provide comments as requested by the
Steering Commiee or SDAG.
3.3.2 Composition
Dependent on the specic needs as identied by the Steering Commiee or SDAG.
All external technical experts involved in the guideline development process were
requested to sign a declaration of interest form (aached as Annex 1).
3.4 Taskforces
Taskforces were established by the SDAG as needed to undertake systematic reviews of the
evidence or conduct consultations with experts when evidence was lacking.
3.4.1 Functions
Undertake systematic reviews if and when appropriate.
Review and synthesize the evidence for possible standards as agreed by SDAG.
Dra recommendations on evidence using the agreed process.
Revise dra standard based on feedback and recommendations from the SDAG.
All external technical advisers involved in the guideline development process were
requested to sign a declaration of interest form (aached as Annex 1).
3.5. Secretariat
The managerial and administrative support to the Steering Commiee and the SDAG were
provided by WHO sta of the Department of Making Pregnancy Safer (MPS).
3.5.1 Functions
Assisting in the planning of activities and monitoring progress according to plans.
Providing relevant background information and materials to the SDAG and the Steering
Commiee.
Organizing the necessary reviews of dras provided by the SDAG.
Assisting in organizing necessary meetings and workshops in Geneva.
Liaising with the RHR documents commiee.
3.5.2 Composition
Coordinators of the SDAG: Ornella Linceo, Della Sherra, Helga Fogstad
WHO administrative support: Catherine Legros, Shamilah Akrams, Nini Zotomayor
8
Annex A: DECLARATION OF INTERESTS FOR WHO EXPERTS
Title of meeting or work to be performed, including description of subject-maer, substance
(compounds and organisms), technology or process to be considered:___________________________
________________________________________________________________________________________
Public health considerations have a primary importance in all WHO technical work. Measures
need to be taken to ensure that the best possible assessment of scientic evidence is achieved in an
independent atmosphere free of either direct or indirect pressures. Thus, to assure the technical
integrity and impartiality of WHOs work, it is necessary to avoid situations in which nancial or
other interests might aect the outcome of that work.
Each expert is therefore asked to declare any interests that could constitute a real, potential or
apparent conict of interest, with respect to his/her involvement in the meeting or work, between
(1) commercial entities and the participant personally, and (2) commercial entities and the
administrative unit with which the participant has an employment relationship. Commercial
entity refers to any company, association (e.g., trade association), organization or any other entity
of any nature whatsoever, with commercial interests.
In addition, as a result of WHOs strong stance against tobacco use, it is considered relevant for the
Organization to know whether experts working with it have, or have had, any relationship with
any part of what may be called the tobacco industry. Nevertheless, declaration of such an interest
would not necessarily be considered a reason to disqualify an expert.
What is a conict of interest?
Conict of interest means that the expert or his/her partner (partner includes a spouse or other
person with whom s/he has a similar close personal relationship), or the administrative unit with
which the expert has an employment relationship, has a nancial or other interest that could
unduly inuence the experts position with respect to the subject-maer being considered. An
apparent conict of interest exists when an interest would not necessarily inuence the expert but
could result in the experts objectivity being questioned by others. A potential conict of interest
exists with an interest which any reasonable person could be uncertain whether or not should be
reported.
Dierent types of nancial or other interests, whether personal or with the administrative unit with
which the expert has an employment relationship, can be envisaged and the following list, which
is not exhaustive, is provided for your guidance. For example, the following types of situations
should be declared:
1. a current proprietary interest in a substance, technology or process (e.g. ownership of a patent),
to be considered in - or otherwise related to the subject-maer - of the meeting or work;
2. a current nancial interest, e.g. shares or bonds, in a commercial entity with an interest in the
subject-maer of the meeting or work (except share holdings through general mutual funds or
similar arrangements where the expert has no control over the selection of shares);
3. an employment, consultancy, directorship, or other position during the past 4 years, whether or
not paid, in any commercial entity which has an interest in the subject-maer of the meeting/
work, or an ongoing negotiation concerning prospective employment or other association with
such commercial entity;
4. performance of any paid work or research during the past 4 years commissioned by a
commercial entity with interests in the subject-maer of the meetings or work;
5. payment or other support covering a period within the past 4 years, or an expectation of
support for the future, from a commercial entity with an interest in the subject-maer of the
meetings or work, even if it does not convey any benet to the expert personally but which
benets his/her position or administrative unit, e.g. a grant or fellowship or other payment, e.g.
for the purpose of nancing a post or consultancy.
With respect to the above, an interest in a competing substance, technology or process, or an
interest in or association with, work for or support by a commercial entity having a direct
competitive interest must similarly be disclosed.
Type of interest, e.g. patent, shares,
employment, association, payment
(including details on any compound,
work, etc.)
Name of commercial entity Belongs to you,
partner or unit?
Current
interest? (or
year ceased)

How to complete this Declaration: Please complete this Declaration and submit it to the Secretariat.
Any nancial or other interests that could constitute a real, potential or apparent conict of
interest should be declared (1) with respect to yourself or partner, as well as (2) with respect to
the administrative unit with which you have an employment relationship. Only the name of the
commercial entity and the nature of the interest is required to be disclosed, no amounts need to be
specied (though they may be, if you consider this information to be relevant to assessing the interest).
With respect to items 1 and 2 in the list above, the interest should only be declared if it is current. With
respect to items 3, 4 and 5, any interest during the past 4 years should be declared. If the interest is no
longer current, please state the year when it ceased. With respect to item 5, the interest ceases when a
nanced post or fellowship is no longer occupied, or when support for an activity ceases.
Assessment and outcome: The information submied by you will be used to assess whether the
declared interests constitute an appreciable real, potential or apparent conict of interest. Such conict
of interest will, depending on the situation, result in (i) you being asked not to take part in the portion
of the discussion or work aecting that interest, (ii) being asked not to take part in the meeting or work
altogether, or (iii) if deemed by WHO to be appropriate to the particular circumstances, and with your
agreement, you taking part in the meeting or work and your interest being publicly disclosed.
Information disclosed on this Form may be made available to persons outside of WHO only when
the objectivity of the meeting or work has been questioned such that the Director-General considers
disclosure to be in the best interests of the Organization, and then only aer consultation with you.
Declaration: Have you or your partner any nancial or other interest in the subject-maer of the
meeting or work in which you will be involved, which may be considered as constituting a real,
potential or apparent conict of interest?
Yes: No: If yes, please give details in the box below.
Do you have, or have you had during the past 4 years, an employment or other professional
relationship with any entity directly involved in the production, manufacture, distribution or sale of
tobacco or any tobacco products, or directly representing the interests of any such entity?
Yes: No: If yes, please give details in the box below.
10
Is there anything else that could aect your objectivity or independence in the meeting or work, or
the perception by others of your objectivity and independence?
_________________________________________________________________________________________________________________
_________________________________________________________________________________________________________________
I hereby declare that the disclosed information is correct and that no other situation of real,
potential or apparent conict of interest is known to me. I undertake to inform you of any change
in these circumstances, including if an issue arises during the course of the meeting or work itself.
_______________________________________ _______________________________________
Signature Date
_______________________________________ _______________________________________
Name Institution
for Maternal and
Neonatal Care
Standards
I NTEGRATED MANAGEMENT OF PREGNANCY AND CHI LDBI RTH (I MPAC)
Requirements
Anationalpolicyandnationalstrategiestoachievehighvaccinationcoverage
withtetanustoxoid(TTorTd)amongpregnantwomenareavailableandare
correctlyimplemented.
IncountrieswithareasathighriskforMNT,strategiesandplanstoimplementa
high-riskapproach,includingvaccinationofwomenofchildbearingage,arein
place.
Allpregnantwomenatendantenatalclinicorcanbereachedbyhealthstafin
thecommunity.
Antenatalcare(ANC)providershavebeentrainedintetanusimmunization.
Thevaccine,equipmentandsupplies(refrigerator,syringes,needles,etc.)needed
toconducttetanusimmunizationarereadilyavailableinthehealthfacilities,
particularlyatANCservices.
Anefectivetetanusvaccinationmonitoringsystemisinplace,including
immunizationregister,personalvaccinationcardsandmaternalhealthrecords.
Allpregnantwomenareissuedapersonalimmunizationcard,whichshouldbe
availableforreferenceateachANCvisitandatanyothercontactwiththehealth
systemthroughoutlife.
Healtheducationactivitiestoincreasecommunityawarenessoftheimportanceof
tetanusimmunizationarecarriedout.
Maternalandneonataltetanusareincludedinthenationalsurveillancesystem.
Maternal immunization
against tetanus
Allwomengivingbirthandtheirnewbornbabiesshouldbeprotected
againsttetanus.
The standard
Topreventmaternalandneonataltetanus(MNT).
Aim
Applying the standard
Healthprovidersofmaternalandneonatalhealthcare,inparticular,must:
Followuniversalstandardsforpreventionofinfectioninallcircumstances.
Ifthewomanhasatetanus-pronewound,includingawomanwhounderwent
anunsafeabortion,protectheragainstfuturetetanusrisksbyimmunizingher
immediatelyifsheisconsiderednotprotected(seetable1).Inaddition,ofer
prophylaxiswithtetanusimmunoglobulinsifthewoundislargeandpossiblyinfected
withsoilorinstrumentscontaminatedwithanimalexcreta.
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1. 1 Maternal i mmuni zati on agai nst tetanus Standards
Beforeadministeringthevaccine,shakethevialwithTTsothatthesedimentatthebotom
mixescompletelywiththeliquid.Ifitissuspectedthatthevaccinehasbeenfrozenandthawed,
checkfordamageusingtheshaketest.Previouslyfrozenvaccineshouldnotbeadministered.
IntheANCservice,checktheimmunizationstatusofthepregnantwoman(eitherbyhistory
orbycard),regardlessofwhetherthereisanintentiontocontinuethepregnancy.Administer
tetanustoxoidifthewomanqualifesforit:
ifthewomanhasnotpreviouslybeenvaccinated,orifherimmunizationstatusisunknown,
givetwodosesofTT/Tdonemonthapartbeforedelivery,andfurtherdosesaspertable1;
ifthewomanhashad14dosesoftetanustoxoidinthepast,giveonedoseofTT/Tdbefore
delivery(atotaloffvedosesprotectsthroughoutthechildbearingyears);
Forthewomantobeprotectedduringpregnancy,thelastdoseoftetanustoxoidmustbegiven
atleasttwoweekspriordelivery.
Recordthedosesgivenonastandardtetanustoxoidimmunizationregisterandonapersonal
immunizationcardormaternalhealthrecord.Thepersonalimmunizationcardshouldbekept
withthewoman.
Age at last
vaccination
Previous immunizations
(based on writen records)
Recommended Immunizations
At present contact/pregnancy
Later (at intervals of
at least one year)
Infancy 3DTP
2dosesofTT/Td(min.4weeks
intervalbetweendoses)
1doseofTT/Td
Childhood 4DTP 1doseofTT/Td 1doseofTT/Td
Schoolage 3DTP+1DT/Td 1doseofTT/Td 1doseofTT/Td
Schoolage 4DTP+1DT/Td 1doseofTT/Td None
Adolescence 4DTP+1DTat4-6yrs+1
TT/Tdat14-16yrs
None None
Table 2 Guidelines for tetanus toxoid immunization of women who were immunized during infancy,
childhood or adolescence
b

b
Adaptedfrom:GalazkaAM.The immunological basis for immunization series. Module 3: tetanus.Geneva,WorldHealthOrganization,1993
(WHO/EPI/GEN/93.13),page17.
ifthewomancanshowwritenproofofvaccinationininfancy,childhoodoradolescencewith
tetanus-containingvaccine(e.g.DTP,DT,Td,TT)administerdosesasindicatedinthetable2.
Dose of TT or Td
(according to card
or history)
When to give Expected duration of protection
1 Atfrstcontactorasearlyaspossibleinpregnancy None
2 Atleast4weeksaferTT1 1-3years
3 Atleast6monthsaferTT2orduringsubsequent
pregnancy
Atleast5years
4 AtleastoneyearaferTT3orduringsubsequent
pregnancy
Atleast10years
5 AtleastoneyearaferTT4orduringsubsequent
pregnancy
Forallchildbearingageyearsand
possiblylonger

Table 1 Tetanus toxoid immunization schedule for women of childbearing age and pregnant women
without previous exposure to TT, Td or DTP
a
a
Source:Core information for the development of immunization policy. 2002update.Geneva.WorldHealthOrganization,2002(documentWHO/
V&B/02.28),page130.
Audit
Input indicators
AnationalpolicyandstrategiesandplansrelatedtoMNTareavailableinhealthfacilities.
ANCcareprovidersareacquaintedwiththevaccinationscheduleandknowhowtocheck
whethertetanustoxoidvaccinehasbeendamaged.
Tetanusvaccines(TTand/orTd)areavailableinhealthfacilitiesoferingmaternalcare.
Community-basedhealtheducationactivitiesarecarriedoutinordertoincreaseANCandTT
immunizationcoverage.
OutreachactivitiesarecarriedoutinordertoincreaseANCandTTimmunizationcoverage.
Process and output indicators
TheproportionofANCservicesprovidingtetanusimmunizationservices.
Theproportionofpregnantwomenimmunizedwithatleasttwodosesoftetanustoxoid(TT2+)
ortheproportionofneonatesprotectedatbirth(PAB).
MonthlyreportsonNTcasesarecompletedanddeliveredontime.
Outcome indicators
Incidenceofneonataltetanus(thetargetislessthan1caseper1000livebirthsatdistrictlevel).
Incidenceofmaternaltetanus.
Burden of sufering
Worldwide,tetanuskillsanestimated180000
neonates(1)(about5%ofallneonataldeaths
(2002data))andupto30000women(2)(about
5%ofallmaternaldeaths)eachyear.Ifthe
motherisnotimmunizedwiththecorrect
numberofdosesoftetanustoxoidvaccine,
neithershenorhernewborninfantisprotected
againsttetanusatdelivery.
Tetanusiscausedbyatoxinproducedduring
theanaerobicgrowthofClostridium tetani.
Infectionisacquiredthroughenvironmental
exposureofanybrokenskinordeadtissue
suchasawoundorwhentheumbilicalcord
iscuttothesporesofthebacteria.These
sporesareuniversallypresentinthesoil.
Poverty,poorhygieneandlimitedaccessto
healthservicesincreasetheriskofMNT.
WHOestimatesthatonly5%ofNTcases
arereported,evenfromcountrieswithwell-
developedsurveillancesystems.Since1989,
whentheWorldHealthAssemblycalled
Rationale
fortheeliminationofNT,110outof161
developingcountriesarethoughttohave
achievedelimination(asoftheendof2004).
UNICEF,WHOandUNFPAagreedin1999
tosettheyear2005asthetargetdatefor
worldwideelimination.Eliminationisdefned
asthereductionofNTcasestolessthan1
per1000livebirthsineverydistrictofevery
country.Thisdefnitionisalsobeingusedasa
proxyfortheeliminationofmaternaltetanus.
Efcacy and efectiveness
Thepurposeofgivingthevaccinetowomen
ofchildbearingageandtopregnantwomen
istoprotectthemfromtetanusandtoprotect
theirnewborninfantsagainstNT(3,4).
Tetanusvaccinationproducesprotective
antibodylevelsinmorethan80%ofrecipients
afertwodoses(13).Twodosesprotectfor
13years,althoughsomestudiesindicate
evenlongerprotection(3).Tetanusvaccineis
safetogiveduringpregnancy(4,5).
Ifacaseofneonataltetanusisidentifed,givethemotheronedoseoftetanustoxoidassoonas
possibleandtreatthebabyaccordingtonationalguidelines.Aseconddoseshouldbegiven(at
least)fourweeksaferthefrst,andathirddoseshouldbegiven(atleast)sixmonthsaferthe
second.Asearchshouldbemadeforothernon-immunizedwomenlivinginthesamearea,and
vaccinationprovidedaccordingly.
RecordallcasesofNTandreporttothedistrictauthority.AllNTcasesfromlow-riskareas
shouldbeinvestigated.
Recordandreportallcasesoftetanusoccurringinotheragegroupsseparately.Wherepossible,
casesofmaternaltetanusshouldbehighlighted,forexamplethroughreporting.
Becausetetanussporesareubiquitousinthe
environment,eradicationisnotbiologically
feasible.Highimmunizationcoverageof
pregnantwomen,cleandeliveryandthe
identifcationandimplementationofcorrective
actioninhigh-riskareasarethethreeprimary
strategiesforeliminatingMNT(seealso
standard2.4.2Careoftheumbilicalcord).
Antenatalservicesprovideaconvenient
opportunityforvaccinatingpregnantwomen
(6,7).WhereANCcoverageisinadequate,
massimmunizationofwomenofchildbearing
agecouldbeanalternativethoughmore
costlyoption(3,5).AboutUS$1.20isneeded
toprotectawomanwiththreedosesofTT/Td
usingthehigh-riskapproach.Reminding
patients,trackingandoutreachactivitiesare
efectiveinincreasingimmunizationcoverage
(8).
Servicesdealingwithpatientswithatetanus-
pronewound,includingwomenwho
underwentanunsafeabortion,shouldalso
immunizethepatientifsheisconsiderednot
protectedtoensurethatsheisnolongeratrisk
inthefuture.Inaddition,prophylaxiswith
tetanusimmunoglobulinsmayberequiredif
thewoundislargeandpossiblyinfectedwith
soilorinstrumentscontaminatedwithanimal
excreta(9).
Efectivesurveillanceiscrucialtomonitoring
progress,andispossibleevenwhereresources
arescarce(9).However,obtainingcomplete
andreliabledatahasproventobedifcult,
asshownbythelowefcacyofreporting.
Incircumstanceswhereabortionisillegalor
sociallyunacceptable,post-abortiontetanus
casesareneglectedandunderreportingcanbe
evenmorecommon.
Study (Type
& Level of
evidence)
Population & Seting
Objective &
Intervention
Outcomes considered for the
Standard
Results
3.Koenigetal.
1998
Observational
study nested
in a
randomized
controlled trial
2+
41571non-pregnant
adultwomen
Bangladesh
(Matlabcholeratrial
1974)
BaselineNT*mortality
rate:14.4/1000livebirths
Toassessvaccine
efcacytoreduce
mortalityfromNT
1or2injectionsof
tetanustoxoidvs
controlgivento
pregnantwomen
Vaccineefcacyrate
Neonatalmortalityondays414
(suspectedNT)
3yearspost-immunization
NTmortality
1 dose vs.
control
91(33-99)
NS
a
NS
2 doses vs.
control
56(17-76)
48(3-73)
74(23-91)
8.Szilagyietal.
2003
Mostrecent
substantive
amendment
August2002
Systematic
review
1++
41studies;morethan
50000patients(children
andadultsover20years
ofage)
Communityseting
Australia,Canada,
Denmark,NewZealand,
USA
Baselineimmunization
rate:
minimum3%
maximum95%
Toidentifyefective
intervention
toimprove
immunizationrate
Utilizationofpatient
reminder/recall
systems
Increasedimmunizationrate
minimum
maximum
Patient reminders vs. control
NNT
b
24(17-35)
NNT34(30-41)

*Neonataltetanus
a
Non-signifcant
b
Numberneededtotreat
Thetablebelowsummarizestheevidencefromthemostrelevantstudies.Thelevelofevidenceis
presentedusingtheNICEmethodologywhichappliesacodingfrom1(highlevel)to4(lowlevel).
Fordetails,seealsotheIntroduction to the Standards for Maternal and Neonatal CareandtheProcess
to develop the Standards for Maternal and Neonatal Careonhtp://www.who.int/making_pregnancy_
safer/publications/en.Foranoverviewofacomprehensivelistofevidence,pleaserefertothe
referencesectionofthestandard.
References
1. ValidationofneonataltetanuseliminationinAndhraPradesh,India.Weekly Epidemiological
Record,2004,79:292297.
2. FauveauVetal.Maternaltetanus:magnitude,epidemiologyandpotentialcontrolmeasures.
International Journal of Gynecology and Obstetrics,1993,40:312.
3. KoenigMAetal.Durationofprotectiveimmunityconferredbymaternaltetanustoxoid
immunization.FurtherevidencefromMatlab,Bangladesh.American Journal of Public Health,
1998,88:903907.
4. StanfeldJP,GallD,BrackenPM.Single-doseantenataltetanusimmunisation.Lancet,1973,
1:215219.
5. BlackRE,HuberDH,CurlinGT.Reductionofneonataltetanusbymassimmunizationof
non-pregnantwomen:durationofprotectionprovidedbyoneortwodosesofaluminium-
adsorbedtetanustoxoid.Bulletin of the World Health Organization,1980,58:927930.
6. MacLennanRetal.ImmunisationagainstneonataltetanusinNewGuinea.Antitoxin
responseofpregnantwomentoadjuvantandplaintoxoids.Bulletin of the World Health
Organization,1965,32:683697.
7. LumbiganonP.Appropriatetechnology:antenatalcare.International Journal of Gynecology and
Obstetrics,1998,63:S91S95.
8. SzilagyiPetal.Interventionsaimedatimprovingimmunizationrates(CochraneReview).In:
The Cochrane Library,Issue 4, 2004.Chichester,JohnWiley&Sons,2004.
9. D.Heymann.Control of communicable diseases manual,18thEdition,WHOandAPHA2004,
p.531.
10. JohnTJetal.Diseasesurveillanceatdistrictlevel:amodelfordevelopingcountries.Lancet,
1998,352:5861.
Links and additional sources
I. Field manual for neonatal tetanus elimination.Geneva,WorldHealthOrganization,1999(document
WHO/V&B/99.14)(htp://www.who.int/vaccines-documents/DocsPDF/www9563.pdf,accessed7
December2004).
II. Maternal and neonatal tetanus elimination by 2005. Strategies for achieving and maintaining elimination.
Geneva,UNICEF,WHO,UNFPA,2000(documentWHO/V&B/02.09)(htp://www.who.int/
vaccines-documents/DocsPDF02/www692.pdf,accessed7December2004).
III. WHO-recommended standards for surveillance of selected vaccine-preventable diseases.Geneva,
WorldHealthOrganization,2003(documentWHO/V&B/03.01)(htp://www.who.int/vaccines-
documents/DocsPDF06/843.pdf,accessed8March,2006).
IV. Immunization in practice. A practical resource guide for health workers. 2004 update. Module 3: The cold
chain. Module 8: Building community support for immunization.Geneva,WorldHealthOrganization,
2004(htp://www.who.int/vaccines-documents/DoxTrng/h4iip.htm,accessed7December2004).
V. GalazkaAM.The immunological basis for immunization series.Module 3: tetanus.Geneva,World
HealthOrganization,1993(documentWHO/EPI/GEN/93.13)(htp://www.who.int/vaccines-
documents/DocsPDF-IBI-e/mod3_e.pdf,accessed7December2004).
VI. Core information for the development of immunization policy. 2002 update.Geneva,WorldHealth
Organization,2002(documentWHO/V&B/02.28)(htp://www.who.int/vaccines-documents/
DocsPDF02/www557.pdf,accessed7December2004).
VII.Postpartum care of the mother and newborn: a practical guide. Report of a technical working group.
Geneva,WorldHealthOrganization,1998(documentWHO/RHT/MSM/98.3)(htp://whqlibdoc.
who.int/hq/1998/WHO_RHT_MSM_98.3.pdf,accessed7December2004).
VIII.Pregnancy, childbirth, postpartum and newborn care: a guide for essential practice.Geneva,World
HealthOrganization,2003(htp://whqlibdoc.who.int/publications/2003/924159084X.pdf,accessed
7December2004).
Thisdocument
isnotaformal
publicationof
theWorldHealth
Organization
(WHO),and
allrightsare
reservedbythe
Organization.
Thedocument
may,however,be
freelyreviewed,
abstracted,
reproducedand
translated,inpart
orinwhole,but
notforsalenorfor
useinconjunction
withcommercial
purposes.
This document is part of the
Standards for Maternal and Neonatal
Care developed by the Department
of Making Pregnancy Safer,
World Health Organization.
For further information please
contact:
DepartmentofMakingPregnancy
Safer(MPS)
WorldHealthOrganization(WHO)
20AvenueAppia
1211Geneva27
Switzerland
Tel:+41227913371
Fax:+41227915853
Email:MPSinfo@who.int
Website:www.who.int/making_
pregnancy_safer/publications/en/
Standards for Maternal and Neonatal Care Steering Commitee
Chair:PaulVanLook,Director,DepartmentofReproductiveHealthandResearch;
OrnellaLinceto,HelgaFogstad,DellaSherrat,AnniePortela,RitaKabraandLucdeBernis
(DepartmentofMakingPregnancySafer).
Acknowledgments
ThisstandardwasdevelopedbyOrnellaLincetowithvaluableinputsfrommembers
oftheabovesteeringcommiteeandWHORegionalOfcesandreviewedataTechnical
ConsultationinGeneva,14-16October2002.MembersoftheCenterforevaluationof
efectivenessofhealthcare-CeVEAS(SimonadiMario,VitorioBasevi,GianfrancoGori,
DanielaSpetoli,DanteBaroncianiandNicolaMagrini)developedthetableofevidenceand
providedadditionalinsightfulreviewoftheevidencesection.WethankJosVandelaerand
MathewsMathaiforhelpfulcommentsonthefnaldraf,FrankTeckstonfortheeditingand
DukeGyamerahforthelayout.
WHOacknowledgesthegenerouscontributionofover80individualsandorganizationsin
thefeldofmaternalandneonatalhealthwhotooktimetoreviewthisdocumentatdiferent
stagesofitsdevelopment.
Thefundingtowardsthepreparationandproductionofthisdocumentprovidedbythe
GovernmentsofAustralia,ItalyandUSAisgratefullyacknowledged.Inaddition,WHOs
MakingPregnancySaferDepartmentisgratefultotheGovernmentsofDenmark,Ireland,
Netherlands,Norway,Sweden,andtheUnitedKingdom,andtotheWorldBank,UNICEF
andUNFPAforunspecifedprogrammesupport.
for Maternal and
Neonatal Care
Standards
| NTLGPATLD MANAGLMLNT OP PPLGNANC AND CH| LD8| PTH (I MPAC)
Requirements
Anationalpolicyandlocallyadaptedguidelinesonthepreventionand
managementofSTIs/RTIsareavailableandarecorrectlyimplemented.
Maternalandneonatalhealthcareprovidersareavailableandarecompetentto
informwomenonthepreventionofSTIs/RTIsandtodiagnoseandtreatthese
infections.
Allessentialequipment,suppliesanddrugsforthediagnosisandmanagementof,
andcounsellingon,STIsareavailableatalllevelsofcare.
STIhealthcareservicesareaccessibleandafordabletopregnantwomenandtheir
partners.
Amechanismforrecordingtestsfor,andtreatmentof,STIsisavailable.
Healtheducationactivitiesarecarriedouttoincreasecommunityawarenessonthe
preventionandmanagementofSTIs/RTIs.
Prevention and management
of sexually transmitted and
reproductive tract infections
Allwomenseenduringpregnancy,childbirthandthepostnatalperiod
shouldbegivenappropriateinformationonthepreventionand
recognitionofsexuallytransmitedinfections(STIs)andreproductive
tractinfections(RTIs).TheyshouldbeassessedforSTIs/RTIsand,when
required,providedwithpromptandefectivetreatmentforthemselves
and,inthecaseofSTIs,theirpartners.
The standard
Toreducematernalandperinatalmorbidityandmortalityandinfertility
causedbySTIs/RTIs.
Aim
Providersofmaternalandneonatalhealthcare,inparticularskilledatendants,must:
Askthepregnantwomanateachantenatalcare(ANC)visit,neardeliveryandinthe
postpartumvisitandinasensitiveandculturallyacceptablemanner,ifshehasany
complaintwhichmaysuggestaSTI/RTI.
IfthewomanhasacomplaintsuggestingaSTI/RTI(suchasabnormalvaginal
discharge,ulcer,lowerabdominalpain,etc.)assessherforsignsandsymptomsof
reproductivetractinfection,includingvaginalexamination.
Performanon-sitesyphilistestinallpregnantwomen,preferablyatthefrstANC
visit,andatdeliveryorinthepostpartumperiod(seealsostandard1.3Preventionof
mother-to-childtransmissionofsyphilis)ifnotdoneearlier.
W
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1. 2 Preventi on and management of sexual l y transmi tted
and reproducti ve tract i nfecti ons
Standards
Audit
Input indicators
NationalpoliciesandstrategiesandguidelinesonSTI/RTIpreventionandtreatmentin
pregnancyareavailableinhealthfacilities.
Theproportionofprimary-levelfacilitiesoferingappropriateSTIdiagnosisandtreatmentat
primary-carelevel.
ThenumberofSTIcasesidentifedandproperlytreated(recordsinantenatal,maternityand
postnatalclinicsandmonthlyreports).
TheproportionofneonatestreatedforcomplicationsduetoSTIs.
Outcome indicators
Prevalenceofsyphilisinpregnancy.
Incidenceofgonorrhoeaandchlamydialinfectionsinpregnancy.
Perinatalmortalityduetosyphilis.
NeonatalmorbidityandsequelaeduetoSTIs(ophthalmia).
HIVtransmission.
WomensandfamiliesawarenessofthenatureofSTIs,howtoavoidthem,whentosuspect
them,wheretogofortreatmentandtheneedtotreatsexualpartners.
Burden of sufering
WHOestimatesthatworldwideabout340
millionnewcasesofcurableSTIsoccur
annually,alargeproportionofthemamong
womeninthereproductiveage(1).In
addition,manymillionsofcasesofincurable
viralSTIs,includinganestimated5million
HIVinfections,occurannually.Mostinfections
beforeconceptionandduringpregnancy
goignoredbymanywomen,becausethe
symptomsaremildoraccesstohealthcare
anddrugsislimited(1).
Rationale
Surveysinfamilyplanningandantenatal
clinicsindevelopingcountriesindicatethat
theprevalencesofsyphilis,gonorrhoeaand
chlamydialinfectionsrangebetween6%
and40%(2).Inmanycountries,STIsare
amongthetopfveconditionsforwhichboth
menandwomenseekcare,representing
aconsiderabledrainonhealthservices.
Althoughinfectionratesaresimilarinboth
menandwomen,theburdenofserious
consequencesofSTIsfallsmostlyonwomen
andtheirinfants.Failuretodiagnoseand
Immediatelytreatorarrangetreatmentforthewoman,herpartner(s)andtheinfantaccording
totheresultsofSTI/RTIcase-fnding,theon-sitesyphilistestandexaminationofthebaby,and
referiftreatmentisnotavailableatthatlevelofcare.
Discusswiththewomantheimportanceoftreatmentforherself,herpartner(s)andthebaby,
explaintheconsequencesofnottreatingtheinfection,anddiscussthenecessityofcondomuse
duringtreatment.
ProvideinformationontheprimarypreventionofSTIs,condomuse,signsandsymptoms
ofSTIsandtheconsequencesforthewomanandtheinfantofleavinginfectionsuntreated,
includingadviceonHIVpreventionandonvoluntarycounsellingandtestingforHIVinfection.
Providefollow-upandreferthewoman,herbabyorpartner(s)incaseofcomplicationsor
treatmentfailure.
Recordthediagnosisandtreatmentprovidedinthehealthfacilityslogbookandintheclients
card.
3
Standards
treatSTIsatanearlystagemayresultin
seriouscomplicationsandsequelae,including
infertility,fetalwastage,neonatalandinfant
infections,aswellasectopicpregnancy,
anogenitalcancerandprematuredeath(3).In
addition,thepresenceofSTIsincreasestherisk
oftransmissionofHIV(1,3).
EfectivemanagementofSTIsiskeytotheir
control,asitpreventsthedevelopmentof
complicationsandsequelae,reducesthe
spreadofthesediseasesinthecommunity
andofersauniqueopportunityfortargeted
educationonHIVprevention.Therefore,
appropriatetreatmentofSTIpatientsattheir
frstencounterwiththehealthservices,and
inparticularinterventionstodetectandtreat
STIsinpregnancy,arebelievedtobeamong
themostcost-efectiveusesofpublichealth
resources(4).Indevelopingcountries,the
prevalenceandincidenceofSTIsarehigh
andtheircomplicationsareveryfrequent,
especiallyinAfricancountries(58).Therefore,
theneedforprovidingscreeningand
treatmentatthefrstvisit,whichforawoman
isofenanANCvisit,issuchthathealth
providersshouldhaveskillsincounselling
andinidentifyingandmanagingSTIsatall
levelsofcare.
WHOsuggestsanumberofstrategiesto
preventandmanageSTIsinhealthfacilities
inlow-incomecountriesduringpregnancy
andinthepostpartumperiod.Theseinclude:
case-fnding;syndromicmanagementand
presumptivetreatmentofcombineddiseases;
on-siteRPRtestsonallpregnantwomen;
treatmentofpartner(s)andofthenewborn
baby;andindividualcounsellingandother
formsofhealtheducation.Theefectiveness
ofsomeofthesestrategieshasbeenreported
throughsystematicreviews(5,6,911).
Case-fndingmeansidentifyingthoseatrisk
by(a)askingthewomanifherpartner(s)has/
haveurethraldischargeorothersymptoms
ofSTI,(b)lookingforsignsofinfectionatthe
antenatalclinic,duringlabouranddelivery
andduringpostnatalvisits,and(c)managing
accordingly.
Syndromicmanagementandpresumptive
treatmentofcombineddiseases,suchas
gonorrhoeaandchlamydia,orsyphilis
andchancroid,mustbeadaptedtothe
epidemiologicalcontextandtreatment
policyofthecountryinquestion(5,6).The
strategyismotivatedbythefactthatdiferent
infectionsmaycoexistorevenreinforce
oneanother(12,13),laboratorydiagnosisis
difcult,expensiveandofennotaccurate
(12-17),whiletreatmentisrelativelycheapand
easy(5).Selectedsyndromiccasedefnition
includesgenitalulcer,urethraldischarge,
vaginaldischargeandlowerabdominalpain.
Syndromicmanagementforgenitalulcers
inbothsexesandurethraldischargeinmen
hasprovedvalidandfeasible(5).However,
evidencefromstudiesconductedinpregnant
womenisstilllimited.Vaginaldischarge
andabdominalpainalgorithmshaveshown
somelimitations,particularlyifappliedto
themanagementofcervical(gonococcaland
chlamydial)infections.Contemporarydirect
examinationofvaginaldischargespecimen
underthemicroscopemayimprovesensitivity
andspecifcity,eventhoughtheyremainfar
fromoptimal(6).Inaddition,theequipment
andskillstousemicroscopyarenotalways
availableattheprimaryhealthcarelevel.
Anon-siteRPRtestonallpregnantwomen
hastheadvantagesofbeingcheap,simpleand
rapiddespitetherelativelylowspecifcitythat
isevenmorereducedinHIV-positivepatients
(13).AmongthediferentavailablerapidSTI
diagnostictests,on-siteRPRandvoluntary
counsellingandtestingforHIVinfection
aretheonlyrecommendedinprimarylevel
facilities(forsyphilisseealsostandard1.3
Preventionofmother-to-childtransmissionof
syphilis).
InthecaseofanSTI,thepartner(s)should
betreatedwheneverpossible(9).Diferent
partnernotifcationstrategieshavebeen
used(18).Itshouldalwaysbeborneinmind
thatdisclosingthewomansconditiontoher
partner(s)canhaveadisruptiveefectandcan
exposethewomantorisk.WHOrecommends
preventivetreatmentofasymptomatic
newbornbabiesifthemothertestspositivefor
syphilisandaspartofroutinenewborncare
topreventophthalmianeonatorum(seealso
standard2.5.2Eyecare).
Recentreviewsindicatethatanumberof
antibioticsefectamicrobiologicalcure
ofgonorrhoeaandchlamydiainfections
andaresafeforuseinpregnancy(1921).
However,theextenttowhichsucha
microbiologicalcurecorrespondstothe
preventionofneonatalorpostnatalinfection
inthemotherhasnotbeenestablished
(19,20).Cefriaxoneanderythromycinarethe
recommendedtreatmentsforgonorrhoeaand
4
Standards
chlamydialinfection,respectively(4,19,20).
Amoxicillinischeaperandbetertolerated
thanerythromycin,andmayrepresentan
acceptablealternativetoerythromycinin
thetreatmentofchlamydialinfectionsin
pregnancy(19).Forgonorrhoea,thesuccess
oftherapywithpenicillinsdependson
theproportionofpenicillinase-producing
Neisseriagonorrhoea(PPNG),whichin
developingcountriesmightbeashighas30%;
itiscommonlyacceptedthatwheneverPPNG
prevalenceexceeds3%itismorecost-efective
totreatempiricallywithanantibioticactive
againstPPNGstrainsthantoscreenandtreat
non-PPNGstrainswithampicillin(4).
Individualcounsellingandotherformsof
healtheducationaimtoincreasecommunity
awarenessofSTItransmissionandthe
consequencesfortheinfantifthepregnant
womanisinfected.Somehealtheducation
strategieshaveundergonesystematicreview,
mainlyincludingstudiesconductedinwestern
countries(10,11).Whileitisclearthathealth
educationincreasessexualknowledge,
promotesbehaviouralchangeandshows
clinicalimpact,thebeneftsareseenonly
whencounsellingincludesthedevelopment
ofnegotiationskillsandthecreationofa
supportiveenvironment(11).Seting-specifc
counsellingisoftheutmostimportance
andrequiresspecifctrainingofhealthcare
providers.
Study
(Type & Level
of evidence)
Population & Seting
Objective &
Intervention
Outcomes linked to the
Standard
Results Comments
5.Sangani,
Rutherford&
Wilson2004
Mostrecent
substantive
amendment
February2004
Systematic
review
1++
Fiverandomized
controlledtrials;
morethan58000
generaladult
populationand
peoplewithSTIs
Peru,SouthAfrica,
Uganda,United
RepublicofTanzania
Baselinerisk
HIVincidence1.8%
STIprevalence
minimum1.2%
maximum54%
Safesexualbehaviour
minimum11%
maximum62%
Todetermine
theimpactof
population-based
STIsinterventions
onthefrequency
ofHIVandSTIs
infectionandquality
ofSTImanagement
(thatis%ofpatient
correctlyexamined,
diagnosed,treated,
compliant,cured,
givenpartner
notificationcard,
condomsand
counseling)
HIVincidence
STIsprevalence
Qualityoftreatment
Safersexualbehaviour
Any intervention vs
control
NS
a
2studies,17925patients
min.NNT490(397-595)
max.NNT11(9-13)
min.NNT61(41-114)
max.NNT11(7-20)
Syndromic
management vs control
NNT
b
146(99-462)
1study,8549patients
NNT52(37-103)
1study,8772patients
min.NNT146
(107-210)
max.NNT2(1-2)
8studies,1786
patients
NS
1study,967patients
Theseareresults
3.Sloan2000
Systematic
review of
validation
studies
2++
32studiesconducted
inantenatal,family
planning,motherand
childhealthclinics
(moderateprevalence
<20%-ofcombined
gonorrhoeaand
chlamydia)andin
STDclinicsoramong
femalesexworkers
(highprevalence
>20%-ofcombined
gonorrhoeaand
chlamydia)
Toassesstheability
ofsimpletoolsusing
acombination
ofriskfactors,
algorithms,clinical
flowcharts,risk
scoringandsimple
laboratoryscreening
tests(including
WHOalgorithm)to
identifygonorrhoea
andchlamydial
infectioninwomen
indeveloping
countries
Individualriskfactors
moderate
prevalence
highprevalence
Symptomsandsigns
moderateprevalence
highprevalence
Simplelaboratory
screeningtests
moderateprevalence
highprevalence
Algorithmsandrisk
scoring
moderateprevalence
highprevalence
Sensitivity
12-69%
45-90%
29-45%
20-58%
31-52%
42-48%
28-54%
47-78%
False
positive
76-92%
59-70%
77-92%
59-71%
89-90%
35-42%
82-90%
54-67%
Inahypothetical
groupof1000women
withmoderate
prevalenceof
infection,using
thescreeningtools
analysed,wewill
correctlytreat35
of100infectedand
incorrectlytreat225
of900uninfected
a
Non-signifcant
b
Numberneededtotreat
Fordetails,seealsotheIntroduction to the Standards for Maternal and Neonatal Care andthe Process to
develop the Standards for Maternal and Neonatal Careonhtp://www.who.int/making_pregnancy_safer/
publications/en.Foranoverviewofacomprehensivelistofevidence,pleaserefertothereference
sectionofthestandard.
5
Standards
Study
(Type & Level
of evidence)
Population &
Seting
Objective &
Intervention
Standard
Results Comments
10.Wald&Link
2002
Systematic
review of
cohort and
case-control
studies
2++
31studies(9cohort
ornestedcase-
controland22
case-control);15
studiesincluded
women,7included
menwhohavesex
withmen(MSM)
and14included
heterosexualmen
20studies
performedinpoor
countriesand11in
richcountries
Todetermine
the
contribution
ofherpes
simplextype
2(HSV2)
infectionto
theriskofHIV
acquisition
Diagnosis
ofHSV2:
type-specific
serology
(nohistory
ofgenital
herpes)
RiskofHSV2-infected
peoplebecomingHIV-
infected
longitudinalstudies
case-control/cross-
sectionalstudies
RiskofHIV-infected
peoplebecomingHSV2-
infected
longitudinalstudies
Populationattributable
risk
a
ofHIVduetoHSV2
infectionHSV2prevalence
22%(generalpopulation,
USA)
HSV2prevalence50%
(Afro-AmericanorMSM,
USA)
HSV2prevalence>80%
(commercialsexworkers)
Relativerisk2.1(1.43.2)
Oddsratio3.9(3.15.1)
Relativerisk4.7(3.36.7)
19%
35%
47%
Success
ofmass
treatmentof
bacterialSTIs
asastrategy
forHIV
prevention
maybe
significantly
limitedby
thehigh
prevalence
ofHSV2
infection
16.Brocklehurst
&Rooney2004
Mostrecent
substantive
amendment
June1998
Systematic
review
1++
11randomized
controlledtrials
involving1449
pregnantwomen
withgenital
Chlamydia
trachomatis
infection
Settingnot
specified
Baselineriskof
microbiological
curefailure
minimum6.6%
maximum27.6%
Toassess
theeffects
ofdifferent
antibioticsin
thetreatment
ofgenital
infectionwith
Chlamydia
trachomatis
during
pregnancy
withrespect
toneonatal
andmaternal
morbidity
Treatment
giventothe
womanandto
thepartner
Microbiologicalcure
Side-effectssufficientto
stoptreatmentavoided
Amoxicillin vs
erythromycin
NS
b
3studies,390
women
NNT11(1013)
4studies,
503women
Azithromycin vs
erythromycin
min.NNT
c
25(1961)
max.NNT
7(518)
4studies,290
women
NNT6(611)
3studies,160
women
Noneof
thestudies
included
resultson
neonatal
death,
ophthalmia
neonatorum,
neonatal
pneumonitis,
maternal
postpartum
endometritis,
clinicalcure
a
Populationatributablerisk:percentageofsexuallytransmitedHIVinfectionsthatcanbeatributedtoHSV2infection(calculatedfrom
longitudinalstudies)
b
Non-signifcant
c
Numberneededtotreat
6
Standards
References
1. Sexually transmited and other reproductive tract infections. A guide to essential practice.Geneva,
WorldHealthOrganization,2005(htp://www.who.int/reproductive-health/pages_resources/
listing_RTIs_STIs.html,accessed2February2006).
2. Globalprevalenceandincidenceofselectedcurablesexuallytransmitedinfections.Overview and
estimates.Geneva,WorldHealthOrganization,2001.(WHO/HIV_AIDS/2001.02andWHO/CDC/
CSR/EDC/2001.01)
3. Guidelines for the management of sexually transmited infections.Geneva,WorldHealthOrganization,
2001(documentWHO/HIV_AIDS/2001.01;WHO/RHR/01.10)(htp://whqlibdoc.who.int/hq/2001/
WHO_HIV_AIDS_2001.01.pdf,accessed2February2006).
4. GencM,MardhPA.Cost-efectivetreatmentofuncomplicatedgonorrhoeaincludingco-infection
withChlamydiatrachomatis.Pharmacoeconomics,1997,12:374-83.
5. SanganiP,RutherfordG,WilkinsonD.Population-basedinterventionsforreducingsexually
transmitedinfections,includingHIVinfection(CochraneReview).In:The Cochrane Library, Issue
4, 2004.Chichester,JohnWiley&Sons,2004.
6. SloanNLetal.Screeningandsyndromicapproachestoidentifygonorrheaandchlamydial
infectionamongwomen.Studies in Family Planning,2000,31:5568.
7. GoyauxNetal.EctopicpregnancyinAfricandevelopingcountries.Acta Obstetricia et
Gynecologica Scandinavica,2003,82:305312.
8. VuylstekeB,LagaM,AlaryM,GerniersMM,LebugheJP,NzilaN,etal.Clinicalalgorithmsfor
thescreeningofwomenforgonococcalandchlamydialinfection:evaluationofpregnantwomen
andprostitutesinZaire.Clinical Infectious Diseases.1993,17(1):82-8.
9. HamrickM,ChamblissML.Bacterialvaginosisandtreatmentofsexualpartners.Archives of
Family Medicine,2000,9:647-8.
10. SongEYetal.Ameta-analysisexaminingefectsofschoolsexualityeducationprogramson
adolescentssexualknowledge,19601997.Journal of School Health,2000,70:413416.
11. ShepherdJetal.Cervicalcancerandsexuallifestyle:asystematicreviewofhealtheducation
interventionstargetedatwomen.Health Education Research,2000,15:681694.
12. RotingenJA,CameronDW,GarnetGP.Asystematicreviewoftheepidemiologicinteractions
betweenclassicsexuallytransmiteddiseasesandHIV:howmuchreallyisknown?Sexually
Transmited Diseases,2001,28:579597.
13. WaldA,LinkK.Riskofhumanimmunodefciencyvirusinfectioninherpessimplexvirustype
2-seropositivepersons:ameta-analysis.Journal of Infectious Diseases,2002,185:152.
14. PatelSRetal.Systematicreviewofdiagnostictestsforvaginaltrichomoniasis.Infectious Diseases
in Obstetrics and Gynecology,2000,8:248257.
15. WieseWetal.Ameta-analysisofthePapanicolaousmearandwetmountforthediagnosisof
vaginaltrichomoniasis.American Journal of Medicine,2000,108:301308.
16. WatsonEJetal.TheaccuracyandefcacyofscreeningtestsforChlamydiatrachomatis:a
systematicreview.Journal of Medical Microbiology,2002,51:102131.
17. NelsonHD,HelfandM.Screeningforchlamydialinfection.American Journal of Preventive
Medicine,2001,20:95107.
18. MathewsCetal.Strategiesforpartnernotifcationforsexuallytransmiteddiseases(Cochrane
Review).In:The Cochrane Library, Issue 4, 2004.Chichester,JohnWiley&Sons,2004.
19. BrocklehurstP,RooneyG.Interventionsfortreatinggenitalchlamydiatrachomatisinfectionin
pregnancy(CochraneReview).In:The Cochrane Library,Issue4,2004.Chichester,JohnWiley&
Sons,2004.
20. BrocklehurstP.Antibioticsforgonorrhoeainpregnancy(CochraneReview).In:The Cochrane
Library, Issue 4, 2004.Chichester,JohnWiley&Sons,2004.
21. LauCY,QureshiAK.Azithromycinversusdoxycyclineforgenitalchlamydialinfections.Ameta-
analysisofrandomizedclinicaltrials.Sexually Transmited Diseases,2002,29:497502.
7
Standards
I. Pregnancy, childbirth, postpartum and newborn care: a guide for essential practice.Geneva,World
HealthOrganization,2003(htp://whqlibdoc.who.int/publications/2003/924159084X.pdf,accessed
13December2004).
II. Care of mother and baby at the health centre: a practical guide.Geneva,WorldHealthOrganization,
1997(documentWHO/FHE/MSM/94.2)(htp://www.who.int/reproductive-health/publications/
msm_94_2/msm_94_2_1.html,accessed13December2004).
Thisdocument
isnotaformal
publicationof
theWorldHealth
Organization
(WHO),and
allrightsare
reservedbythe
Organization.
Thedocument
may,however,be
freelyreviewed,
abstracted,
reproducedand
translated,inpart
orinwhole,but
notforsalenorfor
useinconjunction
withcommercial
purposes.
contact:
Safer(MPS)
20AvenueAppia
1211Geneva27
Switzerland
Tel:+41227913371
Fax:+41227915853
Acknowledgments
ThisstandardwasdevelopedbyOrnellaLincetowithvaluableinputsfrommembersofthe
aboveSteeringCommiteeandWHORegionalOfcesandreviewedataTechnicalConsultation
inGeneva,14-16October2002.MembersoftheCenterforevaluationofefectivenessofhealth
care-CeVEAS(SimonadiMario,VitorioBasevi,GianfrancoGori,DanielaSpetoli,Dante
BaroncianiandNicolaMagrini)developedthetableofevidenceandprovidedadditional
insightfulreviewoftheevidencesection.WethankNathalieBroutetandMathewsMathaifor
helpfulcommentsonthefnaldraf,FrankTeckstonfortheeditingandDukeGyamerahforthe
layout.
WHOacknowledgesthegenerouscontributionofover80individualsandorganizationsinthe
feldofmaternalandneonatalhealthwhotooktimetoreviewthisdocumentatdiferentstages
ofitsdevelopment.
Netherlands,Norway,Sweden,andtheUnitedKingdom,andtotheWorldBank,UNICEFand
UNFPAforunspecifedprogrammesupport.
8
Standards
for Maternal and
Neonatal Care
Standards
Requirements
Anationalpolicyandlocallyadaptedguidelinesonsyphilisprevention,
managementandcareinpregnantwomenareavailableandarecorrectly
implemented.
Allwomenhaveaccesstocareduringpregnancy,childbirthandthepostpartum
period.
Healthcareprovidersarecompetentinsyphilisprevention,screeningduring
pregnancy,treatmentofseropositivepregnantwomenandtheirpartners,
prophylaxisandtreatmentinthenewborn,counsellingonSTIprevention,andhow
topreventre-infectionduringpregnancybypromotingcondomuse.
Oneon-sitescreeningmethodisavailableinantenatalcare(ANC)clinicsand
maternitywards.
SuppliesfortestingareavailableatbothANCandlaboratorylevel.
Laboratorycentresandfacilitiestoensurequalitylaboratorytestingareavailable.
PenicillinisavailableintheANCclinic,maternitywardandpostnatalclinic.
Afunctioningreferralsystemensuresthatpregnantwomenwhoareallergicto
penicillincanbereferredfortreatmenttoahigherlevelofcare.
Anefectivesyphilismonitoringandinformationsystemisavailableforpregnant
women.
Healtheducationactivitiesarecarriedouttoraisetheawarenessofindividuals,
familiesandcommunitiesoftheimportanceofatendingANCclinicsearlyin
pregnancyforsyphilispreventionandtreatment.
Prevention of
mother-to-child
transmission of syphilis
Allpregnantwomenshouldbescreenedforsyphilisatthefrst
antenatalvisitwithinthefrsttrimesterandagaininlatepregnancy.
Atdelivery,womenwhoforsomereasondonothavetestresults
shouldbetested/retested.Womentestingpositiveshouldbetreated
andinformedoftheimportanceofbeingtestedforHIVinfection.Their
partnersshouldalsobetreatedandplansshouldbemadetotreattheir
infantsatbirth.
The standard
Toreducematernalmorbidity,fetallossandneonatalmortalityand
morbidityduetosyphilis.
Aim
W
o
r
l
d
H
e
a
l
t
h
O
r
g
a
n
i
z
a
t
i
o
n
2
0
0
7
1. 3 Preventi on of mother- to- chi l d transmi ssi on of syphi l i s Standards
Audit
Input indicators
Anationalpolicyandlocallyadaptedguidelinesonsyphilisprevention,managementandcare
inpregnantwomenareavailableandarecorrectlyimplemented.
TheproportionofhealthfacilitiesprovidingANCthathaveascreeningtestforsyphilis
available.
Theavailabilityofascreeningtestforsyphilisinprimarylevelhealthfacilities.
Theavailabilityofpenicillinattheprimarycarelevel(includingANCandchildbirthcare).
HealthprovidersknowwhenandhowtoperformtheRPRtestorVDRL(VenerealDisease
ResearchLaboratory)testorthetestwhichisavailableinthefacility.
Healthprovidersknowwhenandhowtotreatorreferwomenandtheirinfantswithsyphilis.
CoverageofRPRtesting(orotherusedtest)inpregnantwomeninANC.
CoverageofcorrecttreatmentintheANCclinic.
Coverageofpartnerstestedandtreatedaccordingly.
Coverageofasymptomaticbabiesborntoapositivemotherwhoreceivedprophylactic
treatment.
Outcome indicators
Incidenceofcongenitalsyphilis.
Perinatalandneonatalmortalityandmorbidityduetocongenitalsyphilis.
Stillbirthrate.
Providersofmaternalandneonatalhealthcare,inparticularskilledatendants,must:
Screenallpregnantwomenforsyphiliswithon-siteRPRorotheravailablerapidtestatthefrst
antenatalvisit.Screeningshouldbedonepreferablybefore16weeksofgestationtoprevent
congenitalinfection,andagaininthethirdtrimester.
Reviewsyphilistestresultsatsubsequentvisitsandattimeofdelivery.Ifthewomanwasnot
testedduringpregnancy,syphilisscreeningshouldbeoferedaferdelivery.
Treatallseroreactivewomenwithbenzathinebenzylpenicillinattherecommendeddosage
ofatleast2.4millionunitsintramuscularlyasasingledose,aferhavingexcludedallergyto
penicillin.Inthecaseofallergytopenicillin,theatendantshoulddesensitizeandtreatwith
penicilliniftrainedtodoso,orreferthepatienttoahigherlevelofcare.
Advisewomenwhotestpositivethattheirpartner(s)mustalsobetreatedwiththesame
regimen,aswellasthebabyassoonaspossibleaferbirth.
Advisewomenwhotestnegativehowtoremainnegativebypromotingcondomuseduring
pregnancy.
Testforsyphilisallwomenwithahistoryofadversepregnancyoutcome(abortion,stillbirth,
syphiliticinfant,etc.)andtreataccordingly.
Treatwomenwithclinicaldiseaseorahistoryofexposuretoapersonwithinfectioussyphilis.
ScreenallwomenwithsyphilisforotherSTIsandHIVinfection,andprovidecounsellingand
treatmentaccordingly.
OfervoluntarycounsellingandtestingofHIVtoallwomenwhoscreenpositiveforsyphilis.
Makeplansfortreatingthebabyatbirth.
Recordtestingresultsandtreatmentinthefacilityslogbookandinthewomanscard.
Burden of sufering
Syphilisisachronic,ofenlatentinfection
withsomeclinicallyrecognizablestages.
Wherethediseaseisprevalentmostcasesmay
beasymptomatic.Althoughestimatesvary,
atleast50%ofwomenwithacutesyphilis
suferadversepregnancyoutcomes.The
adversepregnancyoutcomesareestimated
tobedistributedasfollow:50%arestillbirths
orspontaneousabortion,and50%perinatal
death,seriousneonatalinfectionorlowbirth
weight.Mortalityininfectedinfantscanbe
higherthan10%(1).
Themorerecentthematernalinfection,the
morelikelytheinfantwillbeafected(2).
Transmissionoccursmorecommonlyinthe
lasttwotrimesters,butthespirochetecancross
theplacentaatanytimeduringpregnancy
(2).Clinicalsimilaritywithothercongenital
diseasesandthelimitationsofdiagnostictests
makeitdifculttoarriveatanearlydiagnosis
inthenewborn(1).
Syphiliscontrolinpregnantwomenthrough
universalantenatalscreeningandtreatment
ofpositivecaseshasbeenestablishedasa
feasibleandcost-efectiveintervention(3,4),
especiallyowingtothehighdirectandindirect
costofcomplicationsofsyphilisinpregnancy
(5)andtheavailabilityofcheapandefective
therapy(68).Nevertheless,inlow-income
countriesanumberoftechnical,logisticaland
structuralconstraintsmakecasedetectionand
treatmentthroughantenatalscreeningdifcult
(4,9),resultinginavoidableperinatalmortality
(10,11).
Non-treponemaltestssuchasRPRandVDRL
arehelpfulindicatorsofinfectionandare
cheaperandeasiertoperformthantreponemal
tests.Theirsensitivityincreasesfromprimary
tosecondarysyphilis,whiletheirspecifcityis
generallyhighintheabsenceofanunderlying
chroniccondition(7);theyarethereforeuseful
forfollow-upafertreatment(68,12).Titres
inafectedpersonsusuallyrisewithinfection
anddecreaseafertreatment(7).Theon-site
RPRtestisquickandsimpletouse,andallows
treatmenttobegivenimmediatelyifindicated;
thisfastprotocolhasprovencost-efective
insetingswheresyphilisprevalenceishigher
than0.15%(13).Nevertheless,thesetests
maygivefalse-negativeresultsintheafected
motherorherbaby(7,14).RPRandVDRL
canalsogivefalse-positiveresultsowingto
Rationale
tissuedamagefromothercauses,suchas
viralinfections,vaccinations,intravenaldrug
abuseandchronicdisease(7).Ideally,non-
treponemaltestsshouldbeconfrmedbya
treponemaltest.Treponemaltestssuchas
theTreponemapallidumhaemagglutination
assay(TPHA)havehighersensitivityand
specifcitybutdonotcorrelatewithdisease
activity,aredifcultandcostlytoconduct,
andarethusnotrecommendedforprimary
healthcarefacilities(7,15,16).Therefore,the
lackofresourcesandhigherprevalenceof
syphilisinlessdevelopedcountriesjustifythe
treatmentofallpeopletestingseropositive
withRPR(12).
Newtreponemal-basedtestsforsyphilismake
on-sitetestingfeasible.Simpleandefective
screeningtestsforsyphilisarenowavailable,
whichcanevenbeusedatthelowestlevels
ofhealthservicedelivery.Asimplestripof
paper,impregnatedwithtreponemalantigen,
isusedtotestbloodobtainedbyfngerprick.
Resultsareavailableinjustafewminutes.
Thesepoint-of-carediagnostictestsare
accurate,afordableandsimpletoperform.
Unlikeearlierdiagnostictests,theydonot
requireaccesstoalaboratoryorarefrigerator.
Inshort,thenewtestsoferapractical
alternativetooldertechniques.Thesetests
havethepotentialtochangethewhole
approachtosyphilistestingeveninisolated
clinics.Becausetheresultscanbeavailable
immediately,womencanbetestedandreceive
treatmentatthesamevisit.Thenewtestscost
amereUS$0.93-1.44perwomanscreened
(16).Althoughthisismorecostlythanthe
previousstandardtests,thenewtestsarein
factmorecost-efective,sincemorewomen
canbetestedandtreatedinatimelymanner
andhencemorecasesofcongenitalsyphilis
prevented.Itisestimatedthatthenewrapid
treponemalbasedtestscostonlyUS$7for
eachcaseofcongenitalsyphilisaverted(17).
Adequatepenicillintreatmentusuallyends
infectivitywithin2448hours.ACochrane
review(18)indicatesthat,whilethereisno
doubtthatpenicillinisefectiveintreating
syphilisinpregnancyandinpreventing
congenitalsyphilis,uncertaintyremainsabout
theoptimaltreatmentregimen(dose,duration
andpreparation)(18).Benzylpenicillin,
administeredparenterallyinasingledose,
isthepreferreddrugfortreatingpregnant
womenandpreventmother-to-child
transmissionofsyphilis(68,18).

Study
(Type & Level
of evidence)
Population &
Seting
Objective & Intervention
Outcomes
considered for
the Standard
Results Comments
10.Rotchford
etal.2000
Observational
study
2+
158pregnant
womenwith
syphilis
ANCclinical
seting;South
Africa
Baseline risk
Syphilis
prevalence
amongpregnant
women9%
(810%)
Perinataldeath
inofspringof
inadequately
treatedpregnant
womenwith
syphilis20%
Tostudytheimpacton
perinatalmortalityof
inadequatetreatmentfor
maternalsyphilis
despiteadequatescreening
Defnition
Completesyphilis
treatment:threedoses
ofpenicillinatweekly
intervals(2.4mega-unitsof
benzathinebenzylpenicillin
intramuscularly)
Adequatesyphilis
treatment:twoormore
dosesofpenicillin
Inadequatesyphilis
treatment:oneornodoses
ofpenicillin
Inadequatesyphilis
treatment
Partnernotifcation
Partnertreatment
Perinataldeath
30%
77%
26%
Adequatevs
inadequate
treatment
NNT
a
5(313)
Despiteefective
screening,
manypregnant
womenwith
syphilisremain
inadequately
treated,
resultingin
avoidable
perinatal
mortality
18.Walker2004
Mostrecent
substantive
amendment
March2001
Systematic
review
1++
26studiesmet
thecriteriafor
detailedscrutiny;
noneofthestudies
includedinthe
review
Toidentifythemost
efectiveantibioticregimen
forsyphilisinpregnant
women,withandwithout
concomitantHIVinfection
Whilethere
isnodoubt
thatpenicillin
isefectivein
thetreatment
ofsyphilisin
pregnancyand
intheprevention
ofcongenital
syphilis,
uncertainty
remainsabout
optimum
treatment
regimens
a
Numberneededtotreat
Singledose,however,wonttreatlatent
syphilisinpregnantwomen.Basedon
theavailableevidence,pregnantwomen
withahistoryofpenicillinallergyshould
bedesensitizedbeforetreatmentwith
benzylpenicillin(8).
Internationalguidelinesrecommendthat
everywomanwhotestsseropositivefor
syphilisbealsotestedforHIVinfection(8).
Althoughthereisnoconclusiveevidence,
itispossiblethatHIVcoinfectionaltersthe
predictivevalueofdiagnostictests(7,8,15).
HIVcoinfectioncouldincreasethepossibility
ofearlydevelopmentofneurosyphilisand
couldincreasethepossibilityoftreatment
failure;someguidelinesthereforesuggest
modifyingcurrentlyrecommendeddose
regimensinthecaseofHIVcoinfection
(68)(seealsostandard1.2Preventionand
managementofsexuallytransmitedand
reproductivetractinfections).
Fordetails,seealsotheIntroduction to the Standards for Maternal and Neonatal Care andthe Process
to develop the Standards for Maternal and Neonatal Careonhtp://www.who.int/making_pregnancy_
Study
(Type & Level
of evidence)
Title & author/
organization
Contents of the recommendations Comments
8.CDC2002
Guideline
4
Sexuallytransmited
diseasestreatment
guidelines
CentresforDisease
Controland
Prevention
UnitedStates
AllpatientwhohavesyphilisshouldbetestedforHIV
infection.
CoinfectionwithHIVcanincreasetheriskofneurologic
complicationandtheriskoftreatmentfailurewithcurrently
recommendedregimens.
Allwomenshouldbescreenedserologicallyforsyphilisat
thefrstprenatalvisit.Insetingofhighsyphilisprevalence,
serologictestingshouldbeperformedtwiceduringthethird
trimester.
Parenteral Penicillin G is the only therapy with documented
efcacy for syphilis during pregnancy.
Basedonavailableevidence,pregnantwomenwhohavea
historyofpenicillinallergyshouldbedesensitizedandtreated
withpenicillin
Parenteral
benzylpenicillinhas
beenusedefectively
forsyphilistreatment
andpreventionfor
morethan50years;
nevertheless,no
comparativetrials
havebeenadequately
conductedtoguide
theselectionofan
optimalregimen
(dose,durationand
preparation)
References
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recommendations.Bulletin of the World Health Organization,2004,82:424430.
2. BermanSM.Maternalsyphilis:pathophysiologyandtreatment.Bulletin of the World Health
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3. ConnorN,RobertsJ,NicollA.Strategicoptionsforantenatalscreeningforsyphilisinthe
UnitedKingdom:acostefectivenessanalysis.Journal of Medical Screening,2000,7:713.
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5. BatemanDAetal.Thehospitalcostofcongenitalsyphilis.Journal of Pediatrics,1997,130:752
758.
6. MusherDM,HamillRJ,BaughnRE.Efectofhumanimmunodefciencyvirus(HIV)infection
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KenyaandSouthAfrica.Bulletin of the World Health Organization,2004,82:410416.
10. RotchfordKetal.Impactonperinatalmortalityofmissedopportunitiestotreatmaternal
syphilisinruralSouthAfrica:baselineresultsfromaclinicrandomizedcontrolledtrial.
Tropical Medicine & International Health,2000,5:800804.
11. GoldenbergRL,ThompsonC.Theinfectiousoriginsofstillbirth.American Journal of Obstetrics
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12. PeelingR.Diagnostictoolsforpreventingandmanagingmaternalandcongenitalsyphilis:
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Thisdocument
isnotaformal
publicationof
theWorldHealth
Organization
(WHO),and
allrightsare
reservedbythe
Organization.
Thedocument
may,however,be
freelyreviewed,
abstracted,
reproducedand
translated,inpart
orinwhole,but
notforsalenorfor
useinconjunction
withcommercial
purposes.
contact:
Safer(MPS)
20AvenueAppia
1211Geneva27
Switzerland
Tel:+41227913371
Fax:+41227915853
Acknowledgments
ThisstandardwasdevelopedbyOrnellaLincetowithvaluableinputsfrommembersofthe
aboveSteeringCommiteeandWHORegionalOfcesandreviewedataTechnicalConsultation
inGeneva,14-16October2002.MembersoftheCenterforevaluationofefectivenessofhealth
care-CeVEAS(SimonadiMario,VitorioBasevi,GianfrancoGori,DanielaSpetoli,Dante
insightfulreviewoftheevidencesection.WethankNathalieBroutetandMathewsMathaifor
helpfulcommentsontheseveraldrafs,FrankTeckstonfortheeditingandDukeGyamerahfor
thelayout.
feldofmaternalandneonatalhealthwhotooktimetoreviewthisdocumentatdiferentstages
ofitsdevelopment.
I. Sexually transmited and other reproductive tract infections. A guide to essential practice.
Geneva,WorldHealthOrganization,2005(htp://www.who.int/reproductive-health/
publications/rtis_gep/index.htm,accessed2February2006).
II. Annual technical report 2002. Section 3. Controlling sexually transmited and reproductive tract
infections.Geneva,WorldHealthOrganization,2002(htp://www.who.int/reproductive-
health/publications/annual_technical_reports/2002/index.html,accessed8March,2006).
III. Motherbaby package: implementing safe motherhood in countries.Geneva,WorldHealth
Organization,1996(documentWHO/FHE/MSM/94.11)(htp://www.who.int/
reproductive-health/publications/MSM_94_11/MSM_94_11_table_of_contents.en.html,
accessed13December2004).
IV. Care of mother and baby at the health centre: a practical guide.Geneva,WorldHealth
Organization,1997(documentWHO/FHE/MSM/94.2)(htp://www.who.int/
reproductive-health/publications/msm_94_2/msm_94_2_1.html,accessed13December
2004).
V. ClohertyJP,StarkA,EichenwaldE.Manual of neonatal care.LippincotWilliams&
Wilkins,1998.
VI. Pregnancy, childbirth, postpartum and newborn care: a guide for essential practice.Geneva,
WorldHealthOrganization,2003(htp://whqlibdoc.who.int/publications/2003/
924159084X.pdf,accessed7December2004).
16. Terris-PrestholtFetal.Isantenatalsyphilisscreeningstillcost-efectiveinsub-Saharan
Africa?Sexually Transmited Infections,2003,79:375-381.
17. BronzanRetal.On-Siterapidantenatalsyphilisscreeningwithanimmunochromatographic
stripimprovescasedetectionandtreatmentinruralSouthAfricanclinics,Bulletin of the
World Health Organization(submited,2005).
18. WalkerGJA.Antibioticsforsyphilisdiagnosedduringpregnancy(CochraneReview).In:The
Cochrane Library, Issue 4, 2004.Chichester,JohnWiley&Sons,2004.
for Maternal and
Neonatal Care
Standards
| NTLGPATLD MANAGLMLNT OP PPLGNANC AND CH| LD8| PTH (I MPAC)
Requirements
Incountrieswhererubellavaccineisincludedinthenationalimmunization
programme,apolicytoprovidevaccineforwomenofchildbearingageis
available;anationalpolicy,nationalimmunizationprogrammeandlocallyadapted
guidelinesonrubellaimmunizationareavailableandarecorrectlyimplementedto
ensuresustainedhighcoverage.
Thevaccine,equipmentandsupplies(coldchain,auto-disablesyringes,needles,
etc.)neededtoconductrubellaimmunizationarereadilyavailableinthehealth
facilities.
Healthpersonnelhavetheknowledgeandskillstodeterminewhenandhowto
vaccinateagainstrubella(includinginjectionsafetyandsafewastedisposal),andto
advisepregnantwomenonpreventionofrubella.
Asystemisinplacetomonitorcoveragewithrubellavaccineinwomenof
childbearingage.
Surveillanceisconductedforrubellainallagegroupsandforcongenitalrubella
syndrome in children <12 months of age using appropriate case defnitions.
Investigationofcasesofrubellainpregnancyandrubellaexposureduring
pregnancyisgivenpriority.
Healtheducationactivitiesarecarriedouttoincreasecommunityawarenessonthe
importanceofpreventingrubellaandcongenitalrubellasyndrome.
Prevention of congenital
rubella syndrome (CRS)
Incountrieswhererubellavaccineisincludedinthenational
immunizationprogramme,womenshouldbeimmunizedagainst
rubellabeforetheybecomepregnant.Inallcountries,pregnantwomen
withsuspectedrubellaorexposuretorubellashouldbefollowedup
andreported.Inallcountries,infantswithsuspectedcongenitalrubella
syndrome(CRS)shouldbeassessedandreported.
The standard
Topreventcongenitalrubellasyndrome(CRS).
Aim
NOTE:Recommendationsinthisstandardarerestrictedtothoserelevanttomanagementofwomeninthe
pre-pregnancy,antenatalandpostpartumperiods,andtheneonate.Extensiverecommendationsonrubellaand
congenitalrubellasyndromeareavailablefromtheWHODepartmentofImmunization,VaccinesandBiologicals.
W
o
r
l
d
H
e
a
l
t
h
O
r
g
a
n
i
z
a
t
i
o
n
2
0
0
6
2 1. 4 Preventi on of congeni tal rubel l a syndrome ( CRS) Standards
Prior to pregnancy and in the postpartum period
Incountrieswhererubellavaccinehasbeenintroducedintothenationalimmunizationschedule,
healthprovidersofmaternalandchildservicesmust:
Vaccinatechildrenaged12monthsorolderand/orschoolgirlsand/orwomenofchildbearing
ageagainstrubella,accordingtonationalpolicyandguidelines.
During pregnancy
In all countries, health providers of maternal and neonatal services, and skilled atendants in
particular,must:
Ensure that rubella vaccine is not ofered to pregnant women and that women are advised to
avoid pregnancy for one month afer rubella vaccination.
Informpregnantwomenoftheimportanceofavoidingcontactwithindividualswithrubella.
Reportandinvestigatesuspectedrubellainpregnancy,exposureofapregnantwomanto
rubella,andinfantswithsuspectedCRS.
Be able to counsel women with confrmed rubella infection during pregnancy on the risk of fetal
abnormalitiesandrelevantlawsandregulationswithrespecttoterminationofthepregancy,if
theysowish.
Reportandinvestigatecasesofsuspectedcongenitalrubellasyndromeinnewbornsandinfants
promptly,asrequiredbythenationalcommunicablediseasesurveillancesystem.
Audit
Input indicators
Nationalguidelinesforimmunizationofwomenagainstrubellaareavailableinthe
health facilities and are known to the health care staf.
Rubellavaccineisavailableandiscorrectlystored.
Health providers correctly ofer and administer rubella vaccine to women as
recommendedbythenationalpolicy(eitherinmasscampaigns,toadolescentsinor
outofschool,intheworkplace,atfamilyplanningclinics,inthepremaritalperiod,or
postpartum).
Asystemisinplacetomonitorrubellavaccinecoverageinwomen.
Thereisafunctioningsurveillancesystemforrubellainallagegroups,withpriorityfor
investigationofsuspectedrubellaorexposuretorubellainpregnantwomen,andfor
congenitalrubellasyndromeinchildren<12monthsofage.
Healthprovidersadvisepregnantwomenonrubellaprevention.
Thenumberandproportionofwomenofchildbearingagevaccinatedagainstrubellaby
districtandbymonth.
Theproportionofwomenofchildbearingagewhoareseropositiveforrubella.
Outcome indicators
Numberofcasesofrubellainallagegroups.
Numberofcasesofrubellainpregnantwomen.
Numberofcasesofcongenitalrubellasyndromeininfants<12monthsofage.
Perinatalmortalityduetocongenitalrubella.
Burden of sufering
Rubellainfectionoccursworldwide.Itis
amild,self-limitinginfectioninchildren
and adults but its efects on the fetus can be
devastating(1).Fetusesinfectedwithrubella
earlyinpregnancyareatgreatestriskof
intrauterinedeath,spontaneousabortionand
congenitalmalformationsofmajororgan
systems(1).Typically,congenitalrubella
syndrome(CRS)ischaracterizedbycongenital
heartdisease,cataractsanddeafness,but
infantswithCRSmayalsopresentwith
singleorcombineddefectsincluding
microcephaly,microphthalmia,congenital
glaucoma,meningoencephalitis,mental
retardation,purpura,hepatosplenomegaly
andbonedisease(1,2).Severeandmoderate
casesarerecognizedatbirth,butmildcases
withonlyslightcardiacinvolvementor
deafnessmaynotbedetecteduntillaterin
infancyorinchildhood.CRSalsohaslate-
onsetmanifestations,includingautism,
diabetesmellitus,andthyroiditis(3).Alarge
prospectivestudyinEnglandandWales
thatfollowedinfantsforameanperiodof26
months,foundthattheriskofrubellabirth
defectswas90%whenthemotherwasinfected
in the frst 11 weeks of pregnancy; 33% in
weeks 11-12; 11% in weeks 13-14; and 24% in
weeks15-16(4).AstudyinSwedenfoundthat
theriskwas2%whenthemotherwasinfected
duringweeks17-20ofpregnancy,with
deafnessasthesoledefect(5).
In1996,WHOsponsoredaglobal
epidemiologyreviewtoassesstheevidence
fortheoccurrenceofCRSindeveloping
countries(6).Morethan50developing
countrieswerefoundtohaveconducted
studies on the burden of CRS, and 14 of these
providedincidenceratesfornumberofCRS
casesper1000livebirths.Intheoutbreak
seting, the incidence of CRS was 0.6-2.2 per
1000livebirths.Theseratesaresimilarto
thosereportedinindustrializedcountries
beforevaccinationwasintroduced.These
dataexcludeabortionandareunderestimates
ofcongenitalmalformations,sinceonly
anomaliesthatweremanifestatbirthor
during the frst months of life were included.
Altogether 43 developing countries had
conductedrubellaserosurveysinhealthy
womenofchildbearingagewithasamplesize
of at least 100 women. In 12 countries 25% of
womenofchildbearingageweresusceptible
and in 20 countries 10-24% were susceptible;
highsusceptibilityratesindicatethatthereare
manywomenatriskfordeliveryofaninfant
Rationale
withCRS.Basedonserosurveydata,amodel
wasdevelopedwhichpredictedtherewere
some110,000newcasesofCRSininfantsin
developingcountries(excludingthoseinthe
EuropeanRegion)in1996(7).
Guidelinesonsurveillanceforrubellain
personsofallages,duringpregnancy,
andforCRSininfantswerepublished
byWHO(8,9).Since2000,allcountries
havebeenrequestedtoreporttheannual
numberofcasesofrubellaandCRSonthe
WHO-UNICEFJointReportingForm,and
thesedataaremaintainedbytheWHO
DepartmentofImmunization,Vaccines
andBiologicalsinGeneva.Inrecentyears,
therehasbeenenormousimprovement
intheglobalunderstandingofrubella
epidemiology,thankstothenearly700
laboratories(reference,regional,national,
andsubnational)participatingintheWHO
GlobalMeasles/RubellaLaboratoryNetwork.
WHOregionswithrubellaelimination
targets(theAmericasandEurope)have
standardsforreportingcasesofrubellaand
CRSweeklyormonthly.IntheRegionofthe
Americas,countriesreportcasesofrubella
andCRSweekly,withpublicationofthese
data (htp://www.paho.org/english/AD/FCH/
IM/Measles.htm).IntheEuropeanRegion,
47 of 52 countries have established rubella
surveillanceandthesedataarereported
monthly (htp://www.euro.who.int/vaccine).
By 2003, some 131 countries/territories (60%)
outofatotalof215countries/territories
haveaddedrubellavaccinetotheirnational
immunizationsystem.TwoWHOregions
-theAmericasandEurope-haveestablished
regionaltargetsforeliminationofrubellaand
CRSbytheyear2010(10-14).
There is no specifc therapy for maternal
orcongenitalrubellainfection.Thevalue
of immunoglobulin given afer exposure
earlyinpregnancyhasnotbeenestablished.
TheprimarymeansofpreventingCRSis
byrubellaimmunization.Rubellavaccine
is highly efective: a single dose of the most
commonly used RA27/3 rubella vaccine strain
leadstoseroconversioninatleast95%of
vaccinees and is thought to aford lifelong
protection(3).Allstudiesthathaveexamined
cost-efectiveness of rubella vaccination have
found a positive cost-beneft ratio (15).
AWHOpositionpaperonrubellavaccines
*CRScongenitalrubellasyndrome
providesextensiveguidanceforcountries
(3).WHOrecommendsthatallcountries
shouldassesstheirrubellasituationand,if
appropriate,makeplansfortheintroduction
ofrubellavaccine.
Theprimarypurposeofrubellavaccination
istopreventCRS.Twoapproachesare
recommended:(a)preventionofCRS
only,throughimmunizationofwomenof
childbearingage;or(b)eliminationofrubella
aswellasCRS,throughimmunization
ofyoungchildrenaswellaswomenof
childbearingage(3).Thedecisiontoinclude
rubellavaccineismadeatthenationallevel
andthechoiceofapproachshouldbebasedon
thelevelofrubellasusceptibilityinwomenof
childbearingage;theburdenofdiseasedueto
CRS;thestrengthofthebasicimmunization
programmeasindicatedbyroutinemeasles
vaccinecoverage(whichshouldbe>80%for
severalyearsbeforeimplementingchildhood
rubellavaccination);infrastructureand
resourcesforchildandadultimmunization
programmes;assuranceofinjectionsafety;
andotherdiseasepriorities.Apolicyofrubella
vaccinationofwomenofchildbearingageonly
isessentiallyfreeofrisksofalteringrubella
transmissiondynamics,whereasinadequately
implementedchildhoodvaccinationrunsthe
riskofincreasingthenumberofcasesofCRS
(16,17).Therefore,childhoodrubellavaccine
introductionisnotrecommendedunlessthe
nationalprogrammewillbeabletosustain
highlevelsofcoverage(above80%)onalong-
termbasis.
Rubellavaccineshouldbeavoidedin
pregnancybecauseofthetheoreticalbut
neverdemonstratedteratogenicrisk(3).
NocaseofCRShasbeenreportedinmore
than1000susceptiblepregnantwomenwho
inadvertentlyreceivedrubellavaccinein
earlypregnancy;thus,inadvertentrubella
vaccinationduringpregnancyisnotan
indicationforabortion(18).Ifpregnancyis
beingplanned,thenanintervalofonemonth
should be observed afer rubella vaccination.
Generally,theadverseeventsfollowing
vaccination with RA27/3 rubella vaccine are
mild(3).Commonadverseeventsinclude
pain,rednessandindurationatthesiteof
injection.Jointsymptomsarecommonin
adolescentandadultwomenwhoreceive
rubellavaccine;theyincludearthralgia(25%)
andarthritis(10%)thatusuallylastafew
daysto2weeks.Thesetransientreactions
seemtooccurinseronegativeindividuals
only,forwhomthevaccineisimportant.
Althoughconcernshavebeenraisedthat
rubellavaccinationofadultwomenmight
occasionallyleadtochronicarthritis,large
epidemiologicalstudieshavenotsupporteda
roleforrubellavaccineinchronicjointdisease
(3).
Personswithahistoryofanaphylacticreaction
toneomycinshouldnotreceiverubella
vaccine.Rubellavaccineshouldnotbegiven
to immunodefcient individuals, although it is
recommendedforasymptomaticHIV-positive
people(3).Personswithactivetuberculosis
shouldnotreceiverubellavaccineuntil
treatmentisestablished.Breastfeedingis
notacontraindicationtopostpartumrubella
vaccination.Althoughvaccinevirushasbeen
detectedinbreastmilkandtransmissioncan
occur,noillnesshasbeenreportedininfants
(19,20).
RoutineantenatalrubellaIgGantibody
screeningisnotrecommendedforall
countries,asthisisexpensive.Rather,
laboratoryresourcesshouldbedirectedto
diagnosisofrubellainpregnantwomenwho
havesuspectedrubellaorhavebeenexposed
torubella.Abloodspecimenneedstobe
obtained as soon as possible afer suspected
rubellainfectionandthisshouldbesentfor
rubellaIgMantibodytesting.Wherefurther
clarifcation is needed, rubella IgG antibody
testsmaybehelpfuliftheseareavailable.
Researchisongoingtodeterminehowbest
touserubellaaviditytestsasanadditional
diagnosticmethodforpregnantwomen.
NeonateswithCRSshedrubellavirusduring
the frst months of life, and care should be
takenthattheseinfantsarenotincontactwith
pregnantwomen.
Study
(Type & Level of
evidence)
Population &
Seting
Objective &
Intervention
Standard
Results Comments
16.
Panagiotopoulos
etal.1999
Observational
study
3
Children,
adolescents
andwomenof
childbearing
age
Greece
Todescribethe
eventsleading
totheepidemic
ofCRSinGreece
afer a major
rubellaepidemic
1977:MMRvaccinationoptional
1989:MMRvaccination(one
dose)compulsoryforchildren1
yearold
1991:MMRvaccination(two
doses)compulsory(at15months
and1112years)
Averagecoveragewith
MMRinthe1990s:5060%
Proportionofpregnantwomen
susceptibletorubelladuringthe
1980s:12%(1980) 36% (1990)
Rubella epidemic: 1993 (Feb.
June); 64% of cases were 15 years
oldorover
CRS epidemic: 1993 (Sept.Dec.);
25 cases serologically confrmed
with7deaths
RubellaandCRSsurveillance
werepassive,withlikelyhigh
ratesofunderreporting
Withlow
vaccination
coverage,the
immunization
ofchildrenaged
1yearagainst
rubellawithout
anyimmunization
ofwomenin
thepostpartum
periodorinthe
childbearingage
carriestherisk
ofincreasingthe
occurrenceofCRS
18.Vynnycky,Guy
Cuts 2003
Modelling
study
Dynamic
transmission
model
AssumesthatMMRvaccination
isrestrictedtoyoungchildren
Modelindicates
thatincountries
withamedium
tohighforceof
rubellainfection,
levelsofMMR
*
vaccinecoverage
<80%wouldlead,
inthelong-term,to
anincreaseinCRS
Highlightstherisks
ofprivatesector
MMRvaccination.
Concludesthat
systematicrubella
vaccinationshould
beconducted
amongadult
women
15.Hinman,Irons
&Kandola2002
Systematic review
of economic
studies
1+
Diferent
populations
(children,
womenof
childbearing
age,infants)in
diferent parts
oftheworld
12studiesin
developed
countries;
10studiesin
developing
countries
Toinvestigate
whetherthe
incorporation
ofrubella
vaccinationinto
immunization
programmes
indeveloping
countriesis
economically
justifed
AnnualcostoftreatingaCRS
case
LifetimecostoftreatingaCRS
case
Beneft-to-cost ratio
AverageUS$
200014 000
Average
US$ 50 00064 000
Alwayspositive,
rangingfrom2
to 40 depending
onthestrategy
adopted
Onlyresults
fromdeveloping
countriesreported
here
7. Cuts &
Vynnycky.1999
Modellingbased
onserologicaldata
Rubella
serosurvey
datafrom
developing
countries
abstractedfor
preparation
ofasimple
catalyticmodel
toestimate
CRSincidence
Tomodelthe
incidenceofCRS
indeveloping
countries
of diferent
WHOregions
(excluding
Europe)in1996
Estimatedmeannumberofnew
casesofCRSininfantsbornin
1996indevelopingcountries,by
WHOregion
Africa 22,471
Americas 15,994
E.Mediterranean
12,080
SE Asia 46,621
W Pacifc 12,634
Meanglobaltotal
of110,000CRS
casesindeveloping
countriesindicates
CRSisanunder-
recognizedhealth
probleminmany
developing
countries
presented using the NICE methodology which applies a coding from 1 (high level) to 4 (low level).
Fordetails,seealsotheIntroduction to the Standards for Maternal and Neonatal Care andthe Process
to develop the Standards for Maternal and Neonatal Care on htp://www.who.int/making_pregnancy_
*
Measles,mumpsandrubella
References
1. ClohertyJP,StarkA,EichenwaldE.Manual of neonatal care. Lippincot Williams & Wilkins, 1998.
2. Postpartum care of the mother and newborn: a practical guide. Report of a technical working group.Geneva,
World Health Organization, 1998 (document WHO/RHT/MSM/98.3). (htp://whqlibdoc.who.int/
hq/1998/WHO_RHT_MSM_98.3.pdf, accessed 17 December 2004).
3. Rubella vaccines: WHO position paper. Weekly Epidemiological Record, 2000, 75 (20):161-169 (htp://
www.who.int/wer/en/,accessed8March,2006).
4. Miller E, Cradock-Watson JE, Pollock TM. Consequences of confrmed maternal rubella at successive
stagesofpregnancy.Lancet, 1982, 9:781-784.
5. Grillner L, Fosgren M, Barr B, Botiger M, Danielsson L, DeVerdier C. Outcome of rubella during
pregnancy with special reference to the 17-24th weeks of gestation. Scandinavian Journal of Infectious
Diseases, 1983,15:321-325.
6. Cuts FT, Robertson SE, Diaz-Ortega JL, Samuel R. Control of rubella and congenital rubella
syndrome(CRS)indevelopingcountries,part1:burdenofdiseasefromCRS.Bulletin of the World
Health Organization, 1997, 75:55-68 (htp://www.who.int/vaccines-documents/DocsPDF/ww9656a.
pdf,accessed8March,2006).
7. Cuts FT, Vynnycky E. Modelling the incidence of congenital rubella syndrome in developing
countries.International Journal of Epidemiology, 1999, 28:1176-1184.
8. Cuts FT, Best J, Siqueira MM, Engstrom K, Robertson SE. Guidelines for surveillance of congenital
rubella syndrome and rubella, feld test version(May1999).Geneva,WorldHealthOrganization,1999.
(documentWHO/V&B/99.22).
9. WHODepartmentofImmunization,VaccinesandBiologicals.WHO-recommended standards for
surveillance of selected vaccine-preventable diseases.Geneva,WorldHealthOrganization,(document
WHO/V&B, 03.01). (htp://www.who.int/vaccines-documents/DocsPDF/ww9656a.pdf, accessed 8
March,2006).
10. SpikaJSetal.MeaslesandrubellaintheWorldHealthOrganizationEuropeanRegion:diversity
createschallenges.Journal of Infectious Diseases, 2003, 187(Suppl. 1):S191S197.
11. IronsBetal.StrategiestoeradicaterubellaintheEnglish-speakingCaribbean.American Journal of
Public Health, 2000, 90:15451549.
12. Castillo-SolorzanoC,AndrusJK.Rubellaeliminationandimprovinghealthcareforwomen.
Emerging Infectious Diseases, 2005,10(11):2017-20 (htp://www.cdc.gov/ncidod/EID, accessed 8 March, accessed8March,
2006). ).
13. WHO. Progress towards elimination of measles and prevention of congenital rubella infection in
the WHO European Region, 1990-2004. Weekly Epidemiological Record, 2005, 80(8):66-75. (htp://www.
who.int/wer/en/,accessed 8 March, 2006). accessed8March,2006). ).
Study
(Type & Level of
evidence)
Population &
Seting
Objective &
intervention
Outcomes linked to
the Standard
Results Comments
6. Cuts,
Robertson,Diaz-
Ortega&Samuel
1997
Systematic
review of disease
burden studies
from developing
countries
1+
Systematic review
of serosurveys on
rubella immunity
of women of
childbearing age
in developing
countries
1+
CRSsurveillance
studieswith
incidence data: 14
studiesfrom12
developingcountries
Rubella(serum
IgG)susceptibility
in 45 developing
countries,eachof
whichhadatleast
oneserosurveyof
healthywomenwith
asamplesize>100
Toassessthe
incidenceofCRS
amonginfantsin
developingcountries
Toassessthe
potentialriskofCRS
Annualincidence
ofCRSper1000live
births
Rubellasusceptibility
inwomenof
childbearingage
Rangefrom0.6-
2.2CRScases/1000
livebirthsinthe
outbreak seting
>25%susceptible
in12countries;10-
24% susceptible in
20countries;<10%
susceptible in 13
countries
Incidence
comparableto
thatreportedby
industrialised
countriesinthe
pre-vaccinationera
Reviewlimited
todeveloping
countries,since
allindustrialized
countrieshad
alreadyadopted
rubellavaccine
Thisdocument
isnotaformal
publicationof
theWorldHealth
Organization
(WHO),and
allrightsare
reservedbythe
Organization.
Thedocument
may,however,be
freelyreviewed,
abstracted,
reproducedand
translated,inpart
orinwhole,but
notforsalenorfor
useinconjunction
withcommercial
purposes.
contact:
Safer(MPS)
20AvenueAppia
1211Geneva27
Switzerland
Tel: +41 22 791 3371
Fax: +41 22 791 5853
Web site: www.who.int/making_
pregnancy_safer/publications/en
Ornella Linceto, Helga Fogstad, Della Sherrat, Annie Portela, Rita Kabra and Luc de Bernis
Acknowledgments
This standard was developed by Ornella Linceto with valuable inputs from members of the
above steering commitee and WHO Regional Ofces and reviewed at a Technical Consultation
in Geneva, 14-16 October 2002. Members of the Center for evaluation of efectiveness of health
care-CeVEAS (Simona di Mario, Vitorio Basevi, Gianfranco Gori, Daniela Spetoli, Dante
insightfulreviewoftheevidencesection.WethankSusanElizabethRobertsonforhelpful
comments on the fnal draf, Frank Teckston for the editing and Duke Gyamerah for the layout.
feld of maternal and neonatal health who took time to review this document at diferent stages
ofitsdevelopment.
GovernmentsofAustralia,ItalyandUSAisgratefullyacknowledged.Inaddition,WHOsMaking
PregnancySaferDepartmentisgratefultotheGovernmentsofDenmark,Ireland,Netherlands,
Norway,Sweden,andtheUnitedKingdom,andtotheWorldBank,UNICEFandUNFPAfor
unspecifed programme support.
I. Rubellaandcongenitalrubellasyndrome(chapter).In:HeymannDL,editor.Control of Communicable
Diseases Manual, 18th edition.Geneva,WorldHealthAssociationandWashingtonDC:AmericanPublic
Health Association, 2004, pp 464-468.
II. Guidelines for surveillance of congenital rubella syndrome and rubella.Geneva,WorldHealthOrganization,
1999 (document WHO/V&B/00.03) (htp://www.who.int/vaccines-documents/DocsPDF99/www9934.
pdf, accessed 17 December 2004).
III. Pregnancy, childbirth, postpartum and newborn care: a guide for essential practice.Geneva,WorldHealth
Organization, 2003 (htp://whqlibdoc.who.int/publications/2003/924159084X.pdf, accessed 7 December
2004).
IV. ExpandedProgrammeonImmunizationintheAmericas.FLASOGtoparticipateinthe
implementationofstrategiestocontrolrubellaandpreventCRSintheAmericas.EPI Newsleter,2001,
23 (6):7.
V. RobertsonSE,FeatherstoneDA,Gacic-DoboM,HershBS.Rubellaandcongenitalrubellasyndrome:
globalupdate.Pan American Journal of Public Health 2003, 14(5):306-315.
VI. Standardizationofthenomenclatureforgeneticcharacteristicsofwild-typerubellaviruses.Weekly
Epidemiological Record, 2005, 80:126-132. (htp://www.who.int/wer/en/, accessed 8 March, 2006) ,accessed8March,2006) )
VII.WHO.Acceleratedcontrolofrubellaandpreventionofcongenitalrubellasyndrome,Brazil.Weekly
Epidemiological Record 2002, 77:169-175. (htp://www.who.int/wer/en/, accessed 8 March, 2006). ,accessed8March,2006). ).
VIII.Control of rubella and congenital rubella syndrome (CRS) in developing countries.Geneva,WorldHealth
Organization, 2003 (document WHO/V&B/00.03) (htp://www.who.int/vaccines-documents/DocsPDF/
ww9656a.pdf,accessed 8 March, 2006 ). accessed8March,2006 ). ).
14. Expanded Programme on Immunization in the Americas. Rubella and congenital rubella syndrome
eliminationintheAmericas:thebeginningoftheend.EPI Newsleter, 2005, 27(1):1-3.
15. HinmanAR,IronsB,KandolaK.Economicanalysesofrubellaandrubellavaccines:aglobalreview.
Bulletin of the World Health Organization, 2002, 80:264270. (htp://www.who.int/bulletin/en/, accessed accessed
8March,2006). ).
16. Panagiotopoulos T et al. Increase in congenital rubella occurrence afer immunisation in Greece:
retrospectivesurveyandsystematicreview.British Medical Journal, 1999, 319:14621466.
17. Report of a meeting on preventing congenital rubella syndrome: immunization strategies, surveillance needs.
Geneva,WorldHealthOrganization,2000(documentWHO/V&B/00.10).
18. Vynnycky E, Guy NJ, Cuts FT. The predicted impact of private sector MMR vaccination on the
burdenofCongenitalRubellaSyndrome.Vaccine, 2003, 21: 2708-2719.
19. ACOG Commitee Opinion: number 281, December 2002. Rubella vaccination. Obstetrics and
Gynecology, 2002, 100:1417.
20. Canadian Immunization Guide, Sixth edition. Otawa: Canadian Medical Association, 2002.
for Maternal and
Neonatal Care
Standards
Requirements
Anationalpolicyandlocallyadaptedguidelinesonfolicacidsupplementationare
availableandarecorrectlyimplemented.
Healthprovidersarecompetentinthefollowingareas:theriskoffolicaciddefciency;
thebeneftsoffolicacidsupplementationbeforeconceptionandduringearly
pregnancy;correctsupplementdosages;andtheimportanceofadvisingpregnant
womentotakefolicacidbeforeconceptionandduringthefrsttrimesterofpregnancy.
Folicacidisavailableandafordabletowomen.
Amethodtorecordthepreventivetreatmentprovidedisinplace.
Healtheducationactivitiesareconductedtoraisetheawarenessofwomenandofthe
communityontheimportanceoftakingfolicacidsupplementsinthepericonceptional
period.
Prevention of
neural tube defects
Allwomen,fromthemomenttheybegintryingtoconceiveuntil12
weeksofgestation,shouldtakeafolicacidsupplement.Womenwho
havehadafetusdiagnosedasafectedbyaneuraltubedefect(NTD)or
havegivenbirthtoababywithNTDshouldreceiveinformationonthe
riskofrecurrence,beadvisedontheprotectiveefectofpericonceptional
1
folatesupplementationandbeoferedhigh-dosesupplementation.
The standard
TopreventNTDsandothercongenitalmalformationsinthefetus.
Aim
Healthprovidersinantenatalandfamilyplanningclinicsmust:
Advisewomentryingtoconceivetotakeadoseof400gfolicaciddaily,startingtwo
monthsbeforetheplannedpregnancy.
Advisewomenwhohavenotbeensupplementingtheirdietandwhosuspect
themselvestobepregnanttobegintaking400gfolicaciddailyandtocontinueuntil
theyare12weekspregnant.
CounselpregnantwomenwhohavepreviouslyhadababywithNTDorwhohave
diabetesorwhoareunderanticonvulsanttreatmentabouttheincreasedriskofafuture
babybeingafected,andadvisethemtotake5mgfolicaciddailyandincreasetheir
foodintakeoffolate.
Recordthetreatmentgiveninthematernalcard.
RecordcasesofNTD,inaccordancewithlocalguidelines,inthelogbookandinthe
womansrecord.
1
Beforepregnancyandinthefrstthreemonthsofpregnancy.
W
o
r
l
d
H
e
a
l
t
h
O
r
g
a
n
i
z
a
t
i
o
n
2
0
0
6
1. 5 Preventi on of neural tube defects Standards
Burden of sufering
NTDsrepresentoneofthemostcommon
congenitalmalformationsinneonates
worldwide(1).Theyconstitutea
heterogeneousgroupofdisordersthatoccur
duringthefrstweeksofgestation,involving
specifcelementsoftheneuraltubeandits
derivatives(1,2).TheincidenceofNTDsin
thegeneralpopulationvariesfrom1per1000
pregnanciesintheUSAto12per1000inparts
ofIrelandandWalesandamongIndianSikhs
andcertainethnicgroupsinEgypt(1,2).
TheexactcauseofNTDsisnotknown;
over95%occurincoupleswithanegative
familyhistory(1,2).Nevertheless,theriskof
recurrenceis1in33coupleswithoneafected
pregnancyand1in10forthosewithtwo
afectedpregnancies(1).Sistersofwomen
withanafectedchildhavea1in100riskand
sistersofamanwithanafectedchildhavea1
in300risk(1).Folicacidandzincdefciencies
havebeenproposedaspossiblecauses.Known
factorsassociatedwithhigherriskinclude
maternaldiabetes,alcoholabusebythe
mother,aminopteriningestionandantenatal
X-irradiation(1).Suspectedcontributing
factorsareanticonvulsanttherapy,maternal
hyperthermia,antenatalexposuretorubella
andhallucinogeningestion(2).
Folicacidsupplementationbeforeconception
andduringthefrsttrimesterofpregnancy
isoneofthefewpublichealthinterventions
efectiveinreducingtheriskofNTDs(25).
Controlledrandomizedclinicalstudies
showedthatfolicacidsupplementation
Rationale
duringtheperinatalperiodreducedtherisk
ofrecurrenceinwomenwhohadpreviously
borneachildwithNTDs(3).Theevidence
indicatesthatpericonceptionalfolate
supplementationreducestheincidenceof
NTDsinthegeneralpopulation(2,4,5).The
reductionissimilarforfrstandrecurrent
casesofdefects.Owingtotheheterogeneous
etiologyofNTDs,however,theriskcannotbe
eliminatedbythisintervention.
Amongotherfactorspossiblyassociatedwith
NTDsisageneticmutationinvolvingthe
methylenetetrahydrofolatereductasegene
(theC677Tallelicvariant)(6),butitisnot
cleariftheoccurrenceofNTDsamongthe
ofspringofwomenwithsuchamutation
isreducedbyahigherintakeoffolate
(7).Itisalsounclearwhetherthereisa
linkbetweenvitaminB
12
defciencyand
NTDs(8),butanyfuturesupplementation
schemecouldalsoincludethisvitamin(4,9).
Folatesupplementationcouldbeespecially
importantinwomenundergoingfolate-
depletingtreatment,suchaswithantiepileptic
drugs(2,10),aminopterin,methotrexate,
sulfamethoxazoleorpyrimethamine,but
furtherresearchisneededtoreachafrm
conclusion.
Randomizedtrials,supportedbymany
observationalstudies,indicatethat
periconceptionaluseoffolicacidin
multivitaminsupplementsreducestheoverall
riskofbirthdefects,evenaferexcluding
NTDs(11).Thisoverallreductionseemsto
beduetoareducedriskofcardiovascular
anomalies(reductionof34-58%indiferent
studies),orofacialdefects(reductionof
Audit
Input indicators
Policyandlocalguidelinesonfolicacidsupplementationareavailableinclinics.
TrainingonfolicacidsupplementationandNTDsisprovidedtohealthstafofantenataland
familyplanningclinics.
Informationonthebeneftsofincreasingfolicacidintakeisavailableanddisplayedinantenatal
andfamilyplanningclinics.
TheproportionofANCcardsreportingwhetherornotawomanhastakenfolicacidpriorto
conceptionand/orduringthefrst12weeksofpregnancy.
Theproportionofwomenreportingtakingfolicacidsupplementsduringthepericonceptional
period.
Outcome indicators
Incidenceofneuraltubedefectsinthenewborn.
30%),limbdefciencies(reductionof46-81%),
urinarydefects(reduction40-83%),and
onphaloceleandimperforateanus.
Folatesupplementationhasbeenassociated
withasmallincreaseinmultiplegestation,but
arecentsystematicreviewdoesnotsupport
thisfnding(3).Noharmfulefectsoffolate
supplementationhavebeendemonstrated,
eitherintheshortorthelongterm(2,12).
However,ifanincreaseinmultiplegestationis
confrmed,itmightbenecessarytoreconsider
thebeneftsoffolatesupplementation.The
efectivenessoftheintervention,bothin
developedandinlessdevelopedcountries,
dependsoninformingwomenofchildbearing
ageandontheabilitytoplanapregnancy
(13).Possiblealternativesorcomplements
togivingfolatesupplementsaspillscould
beinformationonchangingthediet(7,14)
andfoodfortifcation(5),althoughthese
interventionsalonearelessefectivein
increasingplasmafolatelevelsowingtolower
bioavailability(5,7,14).Iffoodfortifcationis
employed,itisrecommendedthatahigher
leveloffolate(350g/100gfood)beused(15).
IntheNorthAmericanseting,high-dosage
fortifcationisconsideredtohaveahigh
beneft-to-costratio(15).Itisstillunclearasto
whetherNTDscanbepreventedbyincreasing
theconsumptionoffoodsrichinfolates.There
isalsouncertaintyastothebeneftsandrisks
forthewholepopulationfromfortifcationof
basicfoodswithfolate;thisislinkedmainly
tothepossibilityofmaskingpernicious
anaemiainelderlypatientswhoreceivefolate
supplementation(4).
Study
(Type &
Level of
evidence)
Population &
Seting
Objective & Intervention
Outcomes
linked to the
standard
Results Comments
2.Lumley
etal.2004
Mostrecent
substantive
amendment
April2001
Systematic
review
1++
4trials,6425women
Australia,Canada,
France,Hungary,
Ireland,Israel,
UnitedKingdom,
countriesofthe
formerUSSR
Baselineriskof
NTD
minimum0.2%
maximum7.8%
Toassesstheefects
ofpericonceptional
increasedconsumptionof
folateormultivitaminson
theprevalenceofNTD
Thedoseoffolateinthe
trialsrangedfrom0.36to
4mg/day
NTDincidence
minimum
maximum
Miscarriage
Stillbirth
Multiple
gestation
Folate+vitamin
supplementvscontrol
NNT
a
694(5751190)
NNT18(1530)
4studies,6424women
NS
b
3studies,7600women
NS
3studies,7600women
NS
3studies,6241women
Twotrialscomparing
folatealonevs
vitaminsaloneshowed
thatreductioninNTD
isduetofolateandnot
tovitamins
8.Ray&
Blom2003
Systematic
review of
case control
studies
2++
17case-control
studieswere
included,mean
samplesize33cases
and93controls.
Toinvestigatethe
associationbetween
lowmaternalB12and
increasedriskoffetal
NTD
NTD
Lowlevelvshighlevel
ofserumvitaminB12
Oddsratio0.913.3
(0.465.5)
Thereseemstobea
moderateassociation
betweenlowmaternal
vitaminB12statusand
theriskoffetalNTDs;
nofnalconclusions
canbedrawn
References
1. ClohertyJP,StarkA,EichenwaldE.Manual of neonatal care.LippincotWilliams&Wilkins,
1998.
2. LumleyJetal.Periconceptionsupplementationwithfolateand/ormultivitaminstoprevent
neuraltubedefects(CochraneReview).In:The Cochrane Library, Issue 4, 2001.Chichester,
JohnWiley&Sons,2001.
3. CentralTechnicalCo-ordinatingUnit.Multicentricstudyofefcacyofpericonceptionalfolic
acidcontainingvitaminsupplementationinpreventionofopenneuraltubedefectsfrom
India.Indian Journal of Medical Research,2000,112:206211.
a
Numberneededtotreat
b
Non-signifcant
Fordetails,seealsotheIntroduction to the Standards for Maternal and Neonatal Care andthe Process to
develop the Standards for Maternal and Neonatal Careonhtp://www.who.int/making_pregnancy_safer/
I. Auditable standards. Care afer birth.London,RoyalCollegeofObstetriciansand
Gynaecologists,1999.
II. Pregnancy, childbirth, postpartum and newborn care: a guide for essential practice.Geneva,World
HealthOrganization,2003(htp://whqlibdoc.who.int/publications/2003/924159084X.pdf,
accessed7December2004).
4. WaldNJetal.Quantifyingtheefectoffolicacid.Lancet,2001,358:20692073.
5. WilliamsLJetal.Prevalenceofspinabifdaandanencephalyduringthetransitionto
mandatoryfolicacidfortifcationintheUnitedStates.Teratology,2002,66:3339.
6. vanderPutNM,EskesTK,BlomHJ.Isthecommon677C Tmutationinthemethylenetetr
ahydrofolatereductasegeneariskfactorforneuraltubedefects?Ameta-analysis.QJM: An
International Journal of Medicine,1997,90:111115.
7. Ashfeld-WatPALetal.Methylenetetrahydrofolatereductase677C Tgenotypemodulates
homocysteineresponsestoafolate-richdietoralow-dosefolicacidsupplement:arandomized
controlledtrial.American Journal of Clinical Nutrition,2002,76:180186.
8. RayJG,BlomHJ.VitaminB
12
insufciencyandtheriskoffetalneuraltubedefects.QJM: An
International Journal of Medicine,2003,96:289295.
9. BronstrupAetal.EfectsoffolicacidandcombinationsoffolicacidandvitaminB-12on
plasmahomocysteineconcentrationsinhealthy,youngwomen.American Journal of Clinical
Nutrition,1998,5:11041110.
10. YerbyMS.Managementissuesforwomenwithepilepsy:neuraltubedefectsandfolicacid
supplementation.Neurology,2003,61:S23S26.
11. CzeizelAE.Periconceptionalfolicacidcontainingmultivitaminsupplementation.Eur J Obstet
Gynecol Reprod Biol.1998June;78(2):15161.
12. DoboM,CzeizelAE.Long-termsomaticandmentaldevelopmentofchildrenafer
periconceptionalmultivitaminsupplementation.European Journal of Pediatrics,1998,9:719723.
13. ForrestJD.Epidemiologyofunintendedpregnancyandcontraceptiveuse.American Journal of
Obstetrics and Gynecology,1994,170:14851489.
14. VennBJetal.Dietarycounselingtoincreasenaturalfolateintake:arandomized,placebo-
controlledtrialinfree-livingsubjectstoassessefectsonserumfolateandplasmatotal
homocysteine.American Journal of Clinical Nutrition,2002,76:758765.
15. RomanoPSetal.Folicacidfortifcationofgrain:aneconomicanalysis.American Journal of
Public Health,1995,85:667676.
Thisdocument
isnotaformal
publicationof
theWorldHealth
Organization
(WHO),and
allrightsare
reservedbythe
Organization.
Thedocument
may,however,be
freelyreviewed,
abstracted,
reproducedand
translated,inpart
orinwhole,but
notforsalenorfor
useinconjunction
withcommercial
purposes.
contact:
Safer(MPS)
20AvenueAppia
1211Geneva27
Switzerland
Tel:+41227913371
Fax:+41227915853
Acknowledgments
ThisstandardwasdevelopedbyOrnellaLincetowithvaluableinputsfrommembers
oftheabovesteeringcommiteeandWHORegionalOfcesandreviewedataTechnical
ConsultationinGeneva,14-16October2002.MembersoftheCenterforevaluationof
efectivenessofhealthcare-CeVEAS(SimonadiMario,VitorioBasevi,GianfrancoGori,
DanielaSpetoli,DanteBaroncianiandNicolaMagrini)developedthetableofevidenceand
providedadditionalinsightfulreviewoftheevidencesection.WethankBrunodeBenoist
forreviewingfnaldraf,FrankTeckstonfortheeditingandDukeGyamerahforthelayout.
WHOacknowledgesthegenerouscontributionofover80individualsandorganizationsin
thefeldofmaternalandneonatalhealthwhotooktimetoreviewthisdocumentatdiferent
for Maternal and
Neonatal Care
Standards
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Requirements
A national policy and locally adapted guidelines are in place that protect the rights of
all women, regardless of their socioeconomic status or place of residence, to access good
quality ANC services.
National evidence-based guidelines exist detailing the essential minimum components
of ANC, in line with the country epidemiological profle and country priorities and
based on WHO guidelines and recommendations.
The health system ensures that sufcient skilled atendants are recruited and deployed
to be able to provide all women with good quality ANC.
Services and care are organized to ensure that ANC is available and acceptable to all the
women in the service area, regardless of social, religious or ethnic background.
The health system ensures that all necessary equipment and drugs to provide essential
ANC are in place and are in good working order.
Each pregnant woman receives an individual record card on which details of ANC are
given, including all action taken, advice and treatment given, the results of all tests and
examinations and proposed plans for the actual birth; ideally, this record is held by the
woman.
All skilled atendants are linked to, and have the capacity to refer any pregnant woman
to, a facility capable of managing obstetrical and neonatal complications.
National or locally-adapted evidence-based protocols and/or guidelines for the
management of pregnancy-related complications are available and are widely
distributed to all skilled atendants and other health care providers ofering ANC.
Provision of effective
antenatal care
All pregnant women should have at least four antenatal care (ANC)
assessments by or under the supervision of a skilled atendant. These
should, as a minimum, include all the interventions outlined in the new
WHO antenatal care model and be spaced at regular intervals throughout
pregnancy, commencing as early as possible in the frst trimester.
The standard
To prevent, alleviate or treat/manage health problems/diseases (including
those directly related to pregnancy) that are known to have an unfavourable
outcome on pregnancy, and to provide women and their families/partners with
appropriate information and advice for a healthy pregnancy, childbirth and
postnatal recovery, including care of the newborn, promotion of early exclusive
breastfeeding and assistance with deciding on future pregnancies in order to
improve pregnancy outcomes.
Aim
1. 6 Provi si on of effecti ve antenatal care Standards
National and local health education activities and programmes are in place to promote the need
for all women to access ANC, and for all pregnant women, their partners and families to make a
birth and emergency preparedness plan.
Skilled atendants, and other health care providers ofering antenatal care services, must:
Organize ANC services, including scheduling clinic atendance where appropriate, to ensure
that all pregnant women in the locality can access the services.
Work with community leaders and other infuential parties to ensure that the community
understands the benefts of ANC and especially the need for early ANC.
Apply accurately all components of the national antenatal care model identifed for the period
of gestation in question, or as outlined by WHO (1,2), and record these on the home-based ANC
record card.
Provide appropriate health education to all pregnant women and their partners and families,
including healthy lifestyles, healthy diet, smoking cessation where required, preparation for
parenthood, relaxation therapy and/or other activities as required, such as exercises to prepare
the woman for the process of birth.
Ensure that ANC is conducted in a suitable environment that afords privacy.
Provide information and counselling to both partners on postpartum family planning methods.
Ensure that, at some point in the pregnancy, all women have the opportunity to discuss their
pregnancy and personal concerns confdentially, with or without the presence of the partner.
Refer all pregnant women requiring specialized medical care/treatment and all women with
signs of complications of pregnancy.
Refer women with social and/or psychological problems or concerns to an appropriate advice/
service agency.
Record fndings on the maternal card.
Audit
Input indicators
A national ANC policy and locally adapted guidelines are in place.
The availability of skilled ANC atendants.
The proportion of pregnant women having at least one ANC visit.
The proportion of pregnant women having four or more ANC visits.
The proportion of pregnant women able to access ANC within a specifed distance or time span.
The proportion of pregnant women immunized against tetanus.
The proportion of pregnant women screened for syphilis.
The proportion of pregnant women with a writen birth plan by 37 weeks of pregnancy.
Outcome indicators
Proportion of pregnant women satisfed with the ANC services they receive, increased from the
baseline value.
Proportion of pregnant women with a major complication of pregnancy directly referred by the
skilled atendant, increased from the baseline value.
Proportion of pregnant women referred who are assessed by the referral facility as having
received appropriate frst-line management as identifed by WHO (2), increased from the
baseline value.
Burden of sufering
Many maternal and perinatal deaths occur
in women who have received no ANC.
Nevertheless, true progress has been made
globally in terms of increasing access and use.
A recent study on antenatal care estimated that
worldwide only 70% of women ever receive
any ANC, whereas in industrialized countries
more than 95% of pregnant women receive
ANC (3).
Epidemiological studies have demonstrated
the benefts of ANC in reducing maternal
and perinatal complications, although the
exact components and timing of such ANC
has been difcult to demonstrate (4). This
uncertainty leads to the adoption of antenatal
practices that are not comparable and are
largely inconsistent between and within
countries (5,6). There is evidence to show that
certain components of care appear to be more
Rationale
critical than others, whilst some long-held
traditional components have litle scientifc
basis (4,7). Also, there is growing agreement
that ANC should be limited to a small
number of specifc tests carried out at certain
critical times in the pregnancy (4,8,9). The
optimum number of ANC visits for countries
with limited resources is still the subject of
considerable debate, the problem being linked
not only with efectiveness but also with
costs and other barriers to ANC access (5).
Nevertheless, a recent systematic review (7)
showed that essential interventions required
by healthy women with no underlying
medical problems can be provided over
four visits at specifed intervals. The results
of the review also revealed that women in
developed countries receiving ANC through
this four-visit model were less satisfed and
felt their expectations were not met, although
they did not perceive that the care they
received was of lower quality (4,8). The results
of this review prompted WHO to defne a
Box 1. The essential elements of care in pregnancy
The essential elements of care in pregnancy are as follows.
Pregnancy surveillance of the woman and her unborn child.
Preventive measures, including immunization (especially with tetanus toxoid) and screening for
underlying conditions and diseases such as anaemia, malaria, sexually transmited infections (of
which syphilis is particularly important owing to its negative impact on maternal and neonatal health
and the links to a high incidence of stillbirth and low birth weight), HIV infection, and underlying
mental health problems and/or symptoms of stress or domestic violence.
Recognition and management of pregnancy-related complications.
Recognition and treatment of underlying or concurrent illness or disease.
Advice and support to the woman and her family in developing a birth and emergency preparedness
plan.
Health education and promotion for the woman and her family:
to increase awareness of maternal and neonatal health needs and self-care during pregnancy and
the postnatal period, including the need for social support during and afer pregnancy;
to increase health in the home, including healthy lifestyles, healthy diet, health and safety/injury
prevention, and support and care in the home (including adherence to advice on prophylactic
treatments such as iron supplementation, and use of insecticide-treated bednets);
to support care-seeking behaviour, including recognition of danger signs for the woman and the
newborn;
to promote postpartum family planning/birth spacing; and
to prepare emotionally and physically the pregnant woman and her partner and, where required,
supporters for birth.
new model of ANC (1), the essential elements
of which are outlined in Box 1.
Evidence suggests that, given the need for
early identifcation of underlying problems
to ensure efcacious treatment, the frst
ANC visit should be as early as possible in
pregnancy, preferably in the frst trimester
(4). At this visit, there should be a general
assessment of the womans health, with
appropriate remedial action or treatment of
underlying medical conditions, if required,
to try to ensure that the woman is as healthy
as possible during pregnancy and for birth
(4). It is also suggested that, given the lack of
sensitivity in predicting problems, especially
those that occur during or around birth, all
pregnant women should be encouraged to
make a birth and emergency preparedness
plan (see Standard 1.9 Birth and emergency
preparedness in antenatal care for further details).
An antenatal assessment at around 37 weeks
or near the expected date of confnement/birth
is also advisable, to ensure that appropriate
action is taken to prevent problems. Such
appropriate action should include advice on
avoiding postmaturity and the identifcation
of malpresentations, especially breech
presentation, in which case an atempt should
be made at external cephalic version (9).
Thus, there is general consensus that all
women with an uncomplicated pregnancy
should have a minimum of four visits, as
outlined by WHO (1,2).
Evidence also indicates that good record-
keeping is essential to facilitate appropriate
decision-making and interventions. These
records should be available at all times. The
best mechanism to ensure that essential
information is always available is for the
record to stay with the woman. Ensuring the
woman can hold her own records is also a way
to encourage women to feel involved in their
care. A number of studies have shown the
benefts of hand-held or home-based antenatal
care records (10,11). Women who hold their
own records are more likely to keep follow-
up appointments, to ask questions about their
health and to feel in control of their pregnancy
(11). Therefore, home-based or hand-held
records are recommended. Countries may
design their own antenatal care records, but
should ensure that all the essential information
is readily available to the caregiver. A
prototype form is included in the new WHO
model of ANC (1).
Finally, family and community membership
has been shown to be a major determinant
in access to antenatal care services (12). Lone
or unsupported pregnant women, especially
adolescents, therefore need services that are
specifcally targeted to their needs; service
providers should do all they can to seek out
such women and take the services to them, if
they are unable or unwilling to atend a clinic.
Study
(Type & Level of
evidence)
Population & Seting
Objective &
Intervention
Outcomes linked
to the Standard
Results Comments
7. Villar et al. 2004
Most recent
substantive
amendment,
August 2001
Systematic review
1++
10 trials, 7 conducted
in developed
countries (individual
randomization trials)
and 3 in developing
countries (cluster
randomization trials)
Over 60 000 pregnant
women atending
ANC clinics and
considered to be at
low risk of developing
complications during
pregnancy and labour
To assess the efects
of ANC programmes
for low-risk women
Intervention: ANC
programme with
reduced frequency
and timing of visits
compared with
standard frequency
and timing of visits;
ANC programme
based on midwife
support versus
programme
including obstetric/
gynaecological
personnel
Neonatal
and maternal
outcomes
Satisfaction with
care received
Fewer vs standard
number of visits
No diference in
any of the negative
maternal and
perinatal outcomes
reviewed
Trials from developed
countries: women can
be less satisfed with
the reduced number
of visits and feel that
their expectations of
care are not fulflled
ANC by a midwife/
general practitioner
vs obstetric/
gynaecological
personnel
Improved perception
of care by women
No diference in
clinical efectiveness
13. Bricker &
Neilson 2003
Most recent
substantive
amendment,
October 1999
Systematic review
1++
7 trials recruiting
25 036 women in late
pregnancy (afer 24
weeks gestation)
Australia, New
Zealand, Norway,
United Kingdom, USA

Baseline risk
Post-term delivery rate
minimum 0.4%
maximum 4.6%
To assess the
efects of routine
late pregnancy
ultrasound (afer 24
weeks gestation), in
women with either
unselected or low-
risk pregnancies, on
obstetric practice and
pregnancy outcome
Intervention: routine
ultrasound versus
no or selected or
concealed ultrasound
afer 24 weeks of
gestation
Caesarean section
Instrumental
delivery
Post-term delivery
(>42 weeks)

Apgar score <7 at
5 minutes
Perinatal mortality
Routine vs no or
selective ultrasound
NS
a
3 studies, 3886 women
NS
4 studies, 19 037
women
min. NNT
b
809
(5971320)
max. NNT 72 (53119)
2 studies, 1751
neonates*
NS
3 studies, 3891
neonates
NS
6 studies, 22 278
neonates
*Signifcant
data only from
one large study
a
Non-signifcant
b
Number needed to treat. (95% confdence interval)
The table below summarizes the evidence from the most relevant studies. The level of evidence is
For details, see also the Introduction to the Standards for Maternal and Neonatal Care and the Process to
develop the Standards for Maternal and Neonatal Care on htp://www.who.int/making_pregnancy_safer/
publications/en. For an overview of a comprehensive list of evidence, please refer to the reference
section of the standard.
This document
is not a formal
publication of
the World Health
Organization
(WHO), and
all rights are
reserved by the
Organization.
The document
may, however, be
freely reviewed,
abstracted,
reproduced and
translated, in part
or in whole, but
not for sale nor for
use in conjunction
with commercial
purposes.
contact:
Department of Making Pregnancy
Safer (MPS)
World Health Organization (WHO)
20 Avenue Appia
1211 Geneva 27
Switzerland
Tel: +41 22 791 3371
Fax: +41 22 791 5853
Email: MPSinfo@who.int
Chair: Paul Van Look, Director, Department of Reproductive Health and Research;
(Department of Making Pregnancy Safer).
Acknowledgments
This standard was developed by Della Sherrat with valuable inputs from members of the above
Steering Commitee and WHO Regional Ofces and reviewed at a Technical Consultation in
Geneva, 14-16 October 2002. Members of the Center for evaluation of efectiveness of health care-
CeVEAS (Simona di Mario, Vitorio Basevi, Gianfranco Gori, Daniela Spetoli, Dante Baronciani
and Nicola Magrini) developed the table of evidence and provided additional insightful review
of the evidence section. We thank Mathews Mathai for revising the fnal draf, Frank Teckston
for the editing and Duke Gyamerah for the layout.
WHO acknowledges the generous contribution of over 80 individuals and organizations in
the feld of maternal and neonatal health who took time to review this document at diferent
stages of its development.
The funding towards the preparation and production of this document provided by the
Governments of Australia, Italy and USA is gratefully acknowledged. In addition, WHOs
Making Pregnancy Safer Department is grateful to the Governments of Denmark, Ireland,
Netherlands, Norway, Sweden, and the United Kingdom, and to the World Bank, UNICEF
and UNFPA for unspecifed programme support.
References
1. WHO antenatal care randomized trial: manual for implementation of the new model. Geneva, World
Health Organization, 2002 (document WHO/RHR/01.30) (htp://www.who.int/reproductive-
health/publications/RHR_01_30/RHR_01_30.pdf, accessed 5 January 2005).
2. Pregnancy, childbirth, postpartum and newborn care: a guide for essential practice. Geneva, World
Health Organization, 2003 (htp://whqlibdoc.who.int/publications/2003/924159084X.pdf,
accessed 7 December 2004).
3. Antenatal care in developing countries. Promises, achievements and missed opportunities. An analysis
of trends, levels and diferentials, 1990-2001. Geneva, World Health Organization, 2003.
4. Carroli G et al. WHO systematic review of randomised controlled trials of routine antenatal
care. Lancet, 2001, 357:15651570.
5. Perez Woods RC. Barriers to the use of prenatal care: critical analysis of the literature 1966
1987. Journal of Perinatology, 1990, 10:420434.
6. Haertsch M, Campbell E, Sanson Fisher R. What is recommended for healthy women during
pregnancy? A comparison of seven prenatal clinical practice guideline documents. Birth,
1999, 26:2430.
7. Villar J et al. Paterns of routine antenatal care for low-risk pregnancy (Cochrane Review). In:
The Cochrane Library, Issue 4, 2004. Chichester, John Wiley & Sons, 2004.
8. Langer A et al. The evaluation of womens and providers perception of quality of antenatal
care in the WHO Antenatal Care Randomized Controlled Trial. Paediatric and Perinatal
Epidemiology, 1998, 12(Suppl.):98112.
9. Hofmeyr GJ, Kulier R. External cephalic version for breech presentation at term (Cochrane
Review). In: The Cochrane Library, Issue 4, 2004. Chichester, John Wiley & Sons, 2004.
10. Homer CS, Davis GK, Everit LS. The introduction of woman-held record into a hospital
antenatal clinic; the bring your own records study. Australian and New Zealand Journal of
Public Health, 1999, 39:5457.
11. Brown HC, Smith HJ. Giving women their own case notes to carry during pregnancy
(Cochrane Review). In: The Cochrane Library, Issue 4, 2004. Chichester, John Wiley & Sons,
2004.
12. Pebley A, Goldman N, Rodriguez G. Prenatal and delivery care and childhood immunization
in Guatemala: do family and community mater? Demography, 1996, 33:231247.
13. Bricker L, Neilson JP. Routine ultrasound in late pregnancy (afer 24 weeks gestation)
(Cochrane Review). In: The Cochrane Library, Issue 1, 2005. Chichester, John Wiley & Sons,
2004.
for Maternal and
Neonatal Care
Standards
Requirements
Anationalpolicyandguidelinesonprevention,diagnosisandtreatmentofmalariain
pregnancyareavailableandarecorrectlyimplemented.
Healthprovidershavebeentrainedandarecompetentin:malaria-relatedrisksduring
pregnancy;administrationofIPT;advisingontheuseofITNs;anddiagnosisand
treatmentofmalariaduringpregnancy,deliveryandthepostpartumperiod.
Womenhaveaccesstomaternitycare,particularlyintheantenatalperiod.
AntimalarialsforIPTandtreatmentofsymptomaticmalariaandITNsareavailableand
afordable.
Healtheducationactivitiestoincreasecommunityawarenessofmalariapreventionand
treatmentarecarriedout.
Malaria prevention
and treatment
Inmalariousareas,allpregnantwomenshouldsleepunderaninsecticide-
treatedbednet(ITN).Inaddition,inareasofstabletransmissionof
falciparum malaria, all pregnant women should be given intermitent
preventivetreatment(IPT).Pregnantwomensuspectedofhavingmalaria
shouldbeassessedandtreatedinaccordancewithnationalprotocols.In
thepostnatalperiod,boththemotherandthebabyshouldsleepunderan
insecticide-treatedbednet.
The standard
Toreducetheincidenceofnegativeoutcomesinwomenandtheirbabiesdueto
malariaduringpregnancy.
Aim
Providersofmaternalandneonatalhealthcaremust:
Inareasofstablefalciparummalariatransmissiongiveallpregnantwomenatleasttwo
doses of IPT afer quickening (2nd and 3rd trimester) and advise them to seek care in
caseoffever.Dosesshouldbegivenatanintervalatleastonemonth.Toensurethat
womenreceiveatleasttwodoses,IPTshouldbecarriedoutduringroutinevisitstothe
antenatalclinic.WHOcurrentlyrecommendsascheduleoffourantenatalclinicvisits,
three of them afer quickening.
Inmalaria-endemicareas,encourageallpregnantwomentosleepunderanITNfrom
asearlyinpregnancyaspossibleandtocontinueusinganITNduringthepostpartum
period,togetherwiththeirbabies.Theyshouldalsobeencouragedtoseekcareifthe
baby shows danger signs such as fever or difcult breathing.
Assessanypregnantwomanwithanaemiaand/orfeverwhohasbeenexposedto
malariaandtreatherformalariaaccordingtocountryguidelines.
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1. 7 Mal ari a preventi on and treatment Standards
Burden of sufering
The deleterious efects of malaria infection
duringpregnancyonmaternal,fetaland
infant health are caused chiefy by Plasmodium
falciparum. In Africa, at least 25 million
pregnanciesarethreatenedbymalariaeach
year, resulting in an estimated 215% of
maternalanaemia.Maternalmalariainfection
accounts for almost 30% of all the causes
oflowbirthweightthatcanbeprevented
duringpregnancy.Maternalmalariainfection
is estimated to account for 38% of all infant
deaths(1).Inareasofhighandmoderate
(stable)malariatransmission,adultwomen
acquire immunity, and most malaria infections
inpregnantwomenareasymptomatic.
Nevertheless,theseasymptomaticinfections
contributetothedevelopmentofsevere
anaemiainthemother,resultinginan
increasedriskofmaternalmortalityand
morbidity.Thehealthofthefetusandinfant
is afected by maternal infection during the
secondhalfofpregnancy.Malarialinfection
oftheplacentaandmaternalanaemiadue
tomalariacontributetolowbirthweight
andpretermbirth,whichleadtohigher
infantmortalityandmorbidityandimpaired
developmentofthechild.Stabletransmission
predominatesinAfricasouthoftheSahara,
and consequently this region bears the greatest
burdenofmalariainfectionsduringpregnancy.
Intheseareasofhighormoderate(stable)
malaria transmission, the ill-health efects are
particularly apparent in the frst and second
pregnanciesexposedtomalaria(2).
Rationale
Audit
Input indicators
Anationalpolicyandstandardsandlocallyadaptedguidelinesonmalariainpregnancyare
availableinhealthfacilities.
AntimalarialdrugsandITNsareavailableinantenatalclinicsand/oraccessiblethroughthe
commercialmarket.
ProportionofpregnantwomenreceivingIPT.
ProportionofpregnantwomenusingITN.
Appropriatecasemanagementofmalariaillness.
Outcome indicators
Incidenceofcomplications(anaemia,severemalaria,abortion,pretermdelivery)inthemother.
Perinatal/neonatalmortalityandmorbidity(stillbirth,prematurebirth,lowbirthweight,
anaemia,congenitalmalaria).
Awarenessofwomenandtheirfamiliesoftheriskofmalariaforthemselvesandtheirbabies.
Giveadviceonpreventivemeasurestoallpregnantwomenlivinginortravellingtomalarious
areas.
Recordthetreatmentprovidedinthewomansantenatalcarecard.
Malaria during pregnancy in areas
of high or moderate (stable) transmission
IntheabsenceofHIV
infection, frst and
secondpregnanciesat
highestrisk
IPT,ITNs,case
managementofmalaria
andanaemia
Acquired immunity high
Asymptomatic infection
Anaemia
Placental sequestration
Altered placental integrity
Less nutrient transport
Low birth weight
Higher infant
mortality and
morbidity
Inareasofepidemicandlow(unstable)
malariatransmission,adultwomenhaveno
signifcant level of immunity and will develop
clinicalillnessiftheyhaveparasitaemia.
Pregnantwomenwithnoimmunityareat
riskofdyingfromseveremalarialdisease
and/orexperiencingspontaneousabortion,
prematuredelivery,lowbirthweightor
stillbirth.Allpregnantwomenareatsimilar
riskformalarialinfection,irrespectiveof
parity. Abortion is common in the frst
trimester,andprematurityiscommoninthe
third trimester. Other consequences during
pregnancycommonlyassociatedwithP.
falciparuminfectionincludehypoglycaemia,
hyperpyrexia,severehaemolyticanaemiaand
pulmonaryoedema(2).
HIVinfectiondiminishesapregnantwomans
abilitytocontrolP. falciparuminfections.The
prevalenceandintensityofmalariainfection
duringpregnancyishigherinwomenwhoare
HIV-infected.WomenwithHIVinfectionare
morelikelytohavesymptomaticdiseaseand
tobeatincreasedriskofmalaria-associated
adversebirthoutcomes.Multigravidaewith
HIVinfectionaresimilartoprimigravidae
withoutHIVinfectionintermsoftheir
susceptibility to and negative consequences of
malariainfection.
The efects of the other three parasites that
causemalariainhumans(P. vivax, P. malariae
andP. ovale)arelessclear.Thereisaneedfor
studies to beter defne the impact of P. vivax
infectiononthehealthofpregnantwomenand
neonates.
IPT seems to be a feasible and efective
strategyforreducingtheriskofsevere
anaemia(2,3),placentalandperipheral
parasitaemia(25),lowbirthweight(46)
andperinataldeath(3)inprimigravidaeand
secundigravidaelivinginmalaria-endemic
areas, and it is more efcient than selective
casemanagementofclinicalmalaria(5).
Currently, the most efective drug for IPT is
sulfadoxine-pyrimethamine,becauseofits
safety for use during pregnancy, efcacy in
reproductive-agewomenandfeasibilityfor
useinprogrammesasitcanbedeliveredas
asingle-dosetreatmentunderobservation
bythehealthworker(1,2,5,7).Nevertheless,
astudyinMalawishowedthat,evenifIPT
isadoptedasnationalpolicy,obtaininga
widecoverageofpregnantwomenand
assuring efective implementation is not easily
achievable(8). Costefectiveness studies of
IPTarebasedontheassumptionthatANC
coverageisrelativelyhighandwillfurther
increase. Consequently, ANC represents the
bestentrypointforreachingpregnantwomen
withthisintervention(7,9,10).
StudiesinKenyaandMalawihave
demonstratedthatmoredosesofIPTmaybe
benefcial in HIV-infected pregnant women. In
such women, three doses afer quickening may
be needed to derive benefts similar to those
obtainedinuninfectedwomenwithtwodoses
overtheentirepregnancy(5).Noadverse
efects are apparent, in either mothers or their
infants,ofIPTgiveninthesecondandthird
trimestersofpregnancy(2,5).
TheuseofanITNbyapregnantwoman
benefts the woman and her family. Studies
onadultsandchildrenindicatethatITNs
reducetheriskofmalarialinfectionand
overallmortality(11,12).Inhighlymalarious
westernKenya,studiesindicatethatwomen
protected by ITNs every night in their frst
fourpregnanciesdeliveredapproximately
25% fewer babies who were either small for
gestationalageorbornprematurelythan
womenwhowerenotprotectedbyITNs(13).
Inendemicareas,priorityshouldbegivento
developingantenatalclinic-basedprogrammes
thatprovidebothIPTandITNs,alongwith
otheressentialpreventiveinterventions.ITNs
reduce humanvector contact by physically
excluding mosquitoes and either killing or
repellingthem,therebydrivingthemfrom
thevicinityofsleepers.Becauseoftheir
documented efect in several studies on
reducingmalaria-relatedillnessanddeath,
ITNsarebeingpromotedforusethroughboth
publicandprivatesectoroutletsinAfrican
countries.
ITNsarestillrecommendedforareaswith
unstablemalariatransmission,whereasIPT
cannotberecommendedfortheseareas
becauseoflackofevidence.Studiesshouldbe
carriedoutinareasoflow/unstablemalaria
transmissionandwheretheparasiteisP. vivax.
One randomized controlled trial specifcally
assessedthewillingnessofpeopletopayfor
ITNsinanIndianruralarea(14). Some 20%
ofthepopulationwasunwillingtopayany
amountofmoneyforITNs.Ofthosewilling
to pay, almost 30% preferred to do so on an
instalment basis and to pay no more than 12
pernet.
Operationalproblemsrelate,amongothers,to
the difculty to implement IPT in areas of low
ANCcoverage(7).
Study
(Type & Level
of evidence)
Population & Seting
Objective &
Intervention
Outcomes
linked for the
Standard
Results
3. Garner &
Glmezoglu
2003
Mostrecent
substantive
amendment,
July 2002
Systematic
review
1++
14 trials, 8768 women
(insomestudies
onlyprimigravidae
included)
13 trials in African
countries, 1 in Thailand
Baseline risk
Severeantenatal
anaemia
minimum 4%
maximum 24%
Perinataldeath
minimum 11/1000
maximum 178/1000
Lowbirthweight
minimum 9%
maximum 34%
Toassessdrug
efectiveness in
preventingclinical
malariaandits
consequences among
pregnantwomen
livinginmalarious
areas
Interventions:
antimalarialdrug
regimensdescribed
asprophylaxis
(typically chloroquine
givenweekly)or
aspresumptive
treatment
(typicallySP
a
given
intermitently)
Maternal
mortality
Severeantenatal
anaemia
(haemoglobin
<8g/l)
Antenatal
parasite
prevalence
Perinataldeath
Lowbirth
weight
Malaria prophylaxis vs control
1st and 2nd
pregnancies only
NS
b
2 studies, 772
women
min.NNT
c
63 (48
108)
max. NNT 11 (819)
4 studies, 2809
women
NNT 5 (57)
6 studies, 2495
women
min. NNT 337
(1939090)
max. NNT 21
(12562)
3 studies, 1986
neonates
min. NNT 25 (2037)
max. NNT 6 (510)
6 studies, 1947
neonates
All women
NS
1study, 1049 women
NNT 10 (733)
NS
4 studies, 2890
neonates
NS
2 studies, 1438
11. Lengeler
2004
Mostrecent
substantive
amendment,
January 2004
Systematic
review
1++
14 cluster and 8
individualrandomized
controlledtrials,more
than 150 000 people
Africa,SouthAmerica,
MiddleAsiaandSouth-
EastAsia
To assess the efects
ofITNsorcurtainsin
preventingmalaria
Bednetswere
treatedwith
syntheticpyrethroid
insecticide at diferent
concentrations
Childmortality
fromallcauses
Livespotentially
savedin
children 159
months
Severemalaria
(areaofstable
malaria)
Average
haemoglobin
levelinchildren
ITNs vs all controls
Relative risk 0.83 (0.760.89)
5 studies, 149 221 children
5.5/1000 children protected/year
45% protective efcacy
Increased by 1.7% packed cell volume

a
Sulfadoxine-pyrimethamine
b
Non-signifcant
c
Fordetails,seealsotheIntroduction to the Standards for Maternal and Neonatal CareandtheProcess to
develop the Standards for Maternal and Neonatal Care on htp://www.who.int/making_pregnancy_safer/
References
1. A strategic framework for malaria prevention and control during pregnancy in the African region.
Harare, World Health Organization, Regional Ofce for Africa, 2004 (document AFR/
MAL/04/01).
2. Shulman CE et al. Intermitent sulphadoxine-pyrimethamine to prevent severe anaemia sec-
ondarytomalariainpregnancy:arandomisedplacebo-controlledtrial.Lancet, 1999, 353:632
636.
3. Garner P, Glmezoglu AM. Drugs for preventing malaria-related illness in pregnant wom-
enanddeathinthenewborn(CochraneReview).In:The Cochrane Library, Issue 4, 2004.
Chichester, John Wiley & Sons, 2004.
4. DAlessandro U et al. The impact of a national impregnated bed net programme on the out-
comeofpregnancyinprimigravidaeinTheGambia.Transactions of the Royal Society of Tropical
Medicine and Hygiene, 1996, 90:487492.
5. Parise ME et al. Efcacy of sulfadoxine-pyrimethamine for prevention of placental malaria
in an area of Kenya with a high prevalence of malaria and human immunodefciency virus
infection.American Journal of Tropical Medicine and Hygiene, 1998, 59:813822.
6. Menendez C et al. Malaria chemoprophylaxis, infection of the placenta and birth weight in
Gambianprimigravidae.Journal of Tropical Medicine and Hygiene, 1994, 97:244248.
7. Goodman CA, Mills AJ. The evidence base on the costefectiveness of malaria control meas-
uresinAfrica.Health Policy and Planning, 1999, 14:301312.
8. Rogerson SJ et al. Intermitent sulfadoxine-pyrimethamine in pregnancy: efectiveness
against malaria morbidity in Blantyre, Malawi, in 199799. Transactions of the Royal Society of
Tropical Medicine and Hygiene, 2000, 94:549553.
9. Goodman CA, Coleman PG, Mills AJ. Costefectiveness of malaria control in sub-Saharan
Africa.Lancet, 1999, 354:378385.
10. Goodman CA, Coleman PG, Mills AJ. The costefectiveness of antenatal malaria preven-
tioninsub-SaharanAfrica.American Journal of Tropical Medicine and Hygiene, 2001, 64(12,
Suppl.):4556.
11. Lengeler C. Insecticide-treated bednets and curtains for preventing malaria (Cochrane
Review).In:The Cochrane Library, Issue 2, 2004. Oxford, Update Sofware, 2004.
12. Newsome F. Review. Insecticide-treated bednets and curtains reduce overall mortality and
incidenceofmalaria.Evidence-based Medicine, 1999, 4:78.
13. ter Kuile FO et al. Reduction of malaria during pregnancy by permethrin treated nets in
anareaofintensetransmissioninwesternKenya.American Journal of Tropical Medicine and
Hygiene, 2003, 68(4, Suppl.):4556.
14. Bhatia MR, Fox Rushby JA. Willingness to pay for treated mosquito nets in Surat, India.
Thedesignanddescriptiveanalysisofahouseholdsurvey.Health Policy and Planning, 2002,
17:402411.
I. Motherbaby package: implementing safe motherhood in countries.Geneva,WorldHealth
Organization, 1996 (document WHO/FHE/MSM/ 94.11) (htp://www.who.int/reproductive-
health/publications/MSM_94_11/MSM_94_11_table_of_contents.en.html, accessed 13
December 2004).
II. Pregnancy, childbirth, postpartum and newborn care: a guide for essential practice.Geneva,World
Health Organization, 2003 (htp://whqlibdoc.who.int/publications/2003/924159084X.pdf,
accessed 7 December 2004).
Thisdocument
isnotaformal
publicationof
theWorldHealth
Organization
(WHO),and
allrightsare
reservedbythe
Organization.
Thedocument
may,however,be
freelyreviewed,
abstracted,
reproducedand
translated,inpart
orinwhole,but
notforsalenorfor
useinconjunction
withcommercial
purposes.
contact:
Safer(MPS)
20 Avenue Appia
1211 Geneva 27
Switzerland
Tel: +41 22 791 3371
Fax: +41 22 791 5853
Acknowledgments
This standard was developed by Ornella Linceto with valuable inputs from members of the
above Steering Commitee and WHO Regional Ofces and reviewed at a Technical Consultation
in Geneva, 14-16 October 2002. Members of the Center for evaluation of efectiveness of health
insightfulreviewoftheevidencesection.WethankNahlemBernard,PaolaMarchesiniand
Juliana Yartey for helpful comments on the fnal draf, Frank Teckston for the editing and
WHO acknowledges the generous contribution of over 80 individuals and organizations in
the feld of maternal and neonatal health who took time to review this document at diferent
Netherlands, Norway, Sweden, and the United Kingdom, and to the World Bank, UNICEF
and UNFPA for unspecifed programme support.
for Maternal and
Neonatal Care
Standards
Requirements
Anationalpolicyandlocallyadaptedguidelinesonironandfolatesupplementationare
inplaceandarecorrectlyimplemented.
Healthcareprovidersofmaternalandneonatalcarearecompetentin:theimportanceof
ironsupplementationduringpregnancyandthepostpartumperiod;thecorrectdosage
anddurationofsupplementationforthepreventionandtreatmentofanaemia;anaemia
detectioninpregnantwomen;andwhentoreferwomenforfurtherdiagnosisand
treatment.
Ironandfolatesupplementsareavailableatalllevelsofcare.
Thereisafunctioningreferralsystemthatensurestimelyreferralofpregnantwomen
formonitoringandtreatment,especiallyinthecaseofsevereanaemia.
Amechanismisinplaceforrecordingcasesandcareofanaemia.
Healtheducationactivitiesarecarriedouttoincreaseawarenessamongwomenandin
thecommunityoftheimportanceofironandfolatesupplementationinpregnancy.
Iron and folate
supplementation
Allpregnantwomeninareasofhighprevalenceofmalnutritionshould
routinelyreceiveironandfolatesupplements,togetherwithappropriate
dietaryadvice,topreventanaemia.Wheretheprevalenceofanaemiain
pregnantwomenishigh(40%ormore),supplementationshouldcontinue
forthreemonthsinthepostpartumperiod.
The standard
To prevent and treat iron defciency anaemia in women during pregnancy and
inthepostpartumperiodinordertoimprovematernalandperinatalhealth.
Aim
Health providers, in particular skilled atendants, atending women during antenatal and
postpartumvisitsmust:
Giveallpregnantwomenastandarddoseof60mgiron+400gfolicaciddailyfor6
monthsor,if6monthsoftreatmentcannotbeachievedduringthepregnancy,either
continuesupplementationduringthepostpartumperiodorincreasethedosageto120
mgironduringpregnancy.
Wheretheprevalenceofanaemiainpregnancyisover40%,advisethewomanto
continuetheprophylaxisforthreemonthsinthepostpartumperiod.
Giveironsupplementationeveniffolicacidisnotavailable.
Examineorscreenallwomenforanaemiaduringantenatalandpostpartumvisits.
W
o
r
l
d
H
e
a
l
t
h
O
r
g
a
n
i
z
a
t
i
o
n
2
0
0
6
1. 8 I ron and fol ate suppl ementati on Standards
Burden of sufering
Iron-defciency anaemia is the most common
micronutrient defciency in the world,
afecting more than two billion people
globally(1).Itcontributestolowbirthweight,
loweredresistancetoinfection,poorcognitive
developmentandreducedworkcapacity(1).
Pregnantandpostpartumwomenandchildren
aged624monthsareusuallythemost
afected groups (1,2).Itishighlyprevalentin
lessdevelopedcountries,where,inaddition
topoornutrition,parasiticandbacterial
infectionscancontributetodepletionofiron
reserves(14).
Anaemia in pregnancy is defned as
haemoglobin<11g/dlorhaematocrit<33%(1).
It aggravates the efects of maternal blood loss
andinfectionsatchildbirth,andisassociated
withincreasedmaternalandperinatal
mortalityandmorbidity(3,4).Whereanaemia
is prevalent, iron defciency is usually the
mostcommoncause(1).
A substantial reduction in iron defciency
anaemiabytheyear2000wasamongthe
mostimportantnutritionalgoalsadoptedby
the frst World Summit for Children (1990),
reiterated by the International Conference on
Nutrition (1992) (1).
Anaemia prophylaxis
Wheretheprevalenceofanaemiainpregnant
womenis<40%,adoseof60mgironand400
gfolicaciddailyfor6monthsisconsidered
tomeetthephysiologicalrequirements
forironinpregnancy.Ifthedurationof
supplementationisshorter,ahigherdose
(120mg)isrecommended.However,the
majorityofthesystematicreviewsonthis
Rationale
Audit
Input indicators
National standards and locally adapted guidelines for the control of iron defciency anaemia are
availableinhealthfacilities.
Iron/folatesupplementsareavailableandareproperlymanaged.
Staf are available in antenatal care (ANC) and postpartum care (PPC) to prescribe, provide and
administeriron/folatesupplements.
The proportion of women routinely receiving iron/folate supplements during ANC or PPC.
The proportion of women receiving dietary advice during ANC and PPC.
Theproportionofwomenwithsevereanaemiareferred.
Outcome indicators
Maternalmortalityassociatedwithsevereanaemia.
Maternalcomplicationsassociatedwithsevereanaemia.
Perinatalmortalityassociatedwithsevereanaemiainpregnancy.
Incidenceoflowbirthweightassociatedwithanaemiainpregnancy.
Treatanaemiawithdosesof120mgirondailyforthreemonths.
Followupintwoweekstocheckclinicalprogress,testresultsandcomplianceandagainfour
weekslaterallwomenwithsevereanaemiathathavebeentreatedwithironandfolate.
Referwomenwithsevereanaemiatoahigherlevelofcareiftheyareinthelastmonthof
pregnancy,havesignsofrespiratorydistressorcardiacabnormalitiessuchasoedema,orwhen
the conditions do not improve or worsen afer one week of iron/folate therapy.
Provide advice on the consumption of iron-rich foods and vitamin C.
Recordtestresultsandthetreatmentprovidedinthewomanscard.
topicrefertoadoseofaround100mgiron
and350500gfolicaciddailyfor16weeks
ormoreduringpregnancy(57).Inareas
withahigherprevalenceofanaemia,itis
recommendedthatsupplementationcontinue
forthreemonthspostpartum.
Basedonthepossibleassociationbetween
maternalanaemiaandnegativeperinatal
outcome(8), it is assumed that efective iron-
supplementingprogrammeswhereanaemia
isprevalentmayreducetheincidenceof
lowbirthweightandperinatalmortality,as
wellasmaternalmortalityandobstetrical
complicationsassociatedtosevereanaemia.
Accordingtocurrentlyavailablereviews,
however,whilethereisclearevidenceofa
positive efect of routine iron supplementation
duringpregnancyinpreventinglow
haemoglobinatdeliveryoratsixweeks
postpartum(5,6),thereisnoevidenceof
any efect, benefcial or harmful, on clinical
outcomesforthemotherandthebaby(5,6).
The lack of a positive efect might be due to
thesmallsamplesizeinthestudiesthattried
toassessthoseclinicalaspects.Theresultsof
thelargesttrialincludedinonereviewsuggest
thatroutineironsupplementationmayreduce
theneedforpostpartumbloodtransfusions
(5).Thisresultmustbeinterpretedwith
cautionsince,asnotedbytheauthorsofthe
review,thetrialwasnotblindinrespectof
treatmentallocationandtherapeuticdecisions
couldthushavebeenbiased.Nevertheless,if
confrmed, this result could have implications
inHIV-prevalentareas.
Anaemia treatment
Thereisconsensusontheneedforhigher
dosagesintreatingwomenwithanaemia(9).
Thereisevidencethatacombinedtreatment
withironandvitaminAcouldhaveagreater
impactinanaemiatreatmentduringthe
secondtrimesterofpregnancy(9). Severe
anaemiaisnotfrequent,butmaycausealarge
proportionofseveremorbidityandmortality
related to iron defciency. Prompt detection
andtimelytreatmentorreferralofwomen
withsevereanaemiaarethereforeimportant
attheprimarycarelevel.Withpropertraining,
andusingamultiple-siteassessment(inferior
conjunctiva,palmandnailbed)(10),health
workerscanassessextremepallororvery
lowhaemoglobinlevelswithreasonable
sensitivity and high specifcity (1012).Further
improvement of the sensitivity and specifcity
oftheclinicalassessmentcouldbeachieved
byaddingafewanamnesticsymptomsto
thepallorassessmentandusingasimple
colorimetricscale(12).
Since the efectiveness of oral iron
supplementationishinderedbymany
factors,includingsupplyproblemsandpoor
adherencetoregimensowingtothefrequency
of side-efects (5,13,14),avarietyofother
interventionshavebeenproposedtoprevent
and correct iron-defciency anaemia, including
food fortifcation, healthy dietary education
and antiparasitic treatment. The efectiveness
oftheseinterventionsisstillunclear.Dietary
improvements(15) and fortifcation of water
(16)andfoods(17)arenotsupportedby
strong evidence of efectiveness, while control
ofparasitic(helminthandplasmodium)
infectionsseemstoenhanceironprophylaxis
and the efcacy of therapy (14,18).More
researchisneededincommunitieswhereiron-
defciency anaemia is prevalent to establish the
mostappropriatestrategies.
Thereispromisingevidencefromstudies
wherebyironcookingpotsareintroducedat
community level. Cooking in iron pots has
led to a signifcant increase in haemoglobin
concentrations,especiallyamongadults(19),
butthereareproblemsofacceptability(pots
areheavyandwhennotproperlydriedwill
becomerusty)(20).
Study
(Type & Level
of evidence)
Population &
Seting
Objective &
intervention
Outcomes linked
to the Standard
Results Comments
5.Mahomed
2004
Mostrecent
substantive
amendment,
August 1997
Systematic
review
1++
20trials;pregnant
womenpriorto28
weeksgestation
andwithnormal
haemoglobinlevels
(>10g/dl)(number
ofenrolledwomen
not specifed)
Europe,North
America,Australia,
Gambia,India,
Myanmar,Niger
Baselinerisk
Lowpre-delivery
haemoglobinlevel
minimum 9%
maximum56%
Lowpost-delivery
haemoglobinlevel
minimum 9.7%
Toassessthe
efects of iron
supplementation
onhaematological
andbiochemical
parametersandon
pregnancyoutcomes
Intervention:100
mgelementaliron
orallycompared
withplaceboorno
treatment
Inonestudy:iron
givenroutinely
vsirongiven
selectivelyto
womenwith
haemoglobin<10
g/dl
Lowpre-delivery
haemoglobin(<10
g/dl)
Lowhaemoglobin6
weekspostpartum
Caesarean section
Mother:blood
transfusionneeded
Stillbirth/neonatal
death
Side-efects from
treatmentavoided
Iron vs no iron
min.NNT
a
13(1214)
max.NNT2(23)
12studies,1802women
min. NNT 15 (1319)
max. NNT 7 (610)
2studies,1482women
Selective vs routine
iron
NNH
b
42 (20369)
NNH 75 (311011)
NNT 200 (15013 459)
NNT 11 (913)
1 study, 2694 women
Comment from the
authors:increasein
caesareansectionsand
bloodtransfusions
intheselectiveiron
supplementation
grouppossiblydueto
fearofmidwifeand
doctors(notblindto
treatment)
6.Mahomed
2004
Mostrecent
substantive
amendment,
August 1997
Systematic
review
1++
8trialsinvolving
5449 pregnant
womenpriorto28
weeksgestation
andwithnormal
haemoglobinlevels
(>10g/dl)including
adolescentwomen
Myanmar,Nigeria,
UnitedKingdom,
Baselinerisk
Lowpre-delivery
haemoglobinlevel
minimum14%
maximum56%
Lowpost-delivery
haemoglobinlevel
minimum10%
maximum20%
Caesarean section
minimum 9%
maximum11%
Toassessthe
efects of routine
ironandfolate
supplementation
onhaematological
andbiochemical
parametersandon
pregnancyoutcomes
Intervention:100
mgelementaliron
plus350gfolic
acidtakendailyby
mouthcompared
withplaceboorno
treatment
Lowpre-delivery
haemoglobin(<10
g/dl)
Lowhaemoglobin6
weekspostpartum
Caesarean section
Lowbirthweight
Stillbirth/neonatal
death
Iron & folic acid vs
placebo
min. NNT 9 (910)
max.NNT3(23)
min.NNT11(1112)
max.NNT5(56)
min. NNT 14 (1269)
max. NNT 11 (955)
2studies,104women
NS
c
1study,48women
NS1study,48women
Resultsofrelevant
clinicaloutcomesare
basedonaverysmall
singlestudy(low
birthweight,stillbirth,
pretermdelivery)
References
1. Stolzfus RJ, Dreyfuss ML. Guidelines for the use of iron supplements to prevent and treat iron
defciency anemia. Washington, DC, ILSI Press, 1998 (htp://inacg.ilsi.org/fle/b2_VUHUQ8AK.
pdf, accessed 7 January 2005).
2. Motherbaby package: implementing safe motherhood in countries.Geneva,WorldHealth
Organization, 1996 (document WHO/FHE/MSM/ 94.11) (htp://www.who.int/reproductive-
health/publications/MSM_94_11/MSM_94_11_table_of_contents.en.html, accessed 13
December2004).
a
b
Number needed to harm. (95% confdence interval)
c
Non-signifcant
3. Postpartum care of the mother and newborn: a practical guide.Reportofatechnicalworkinggroup.
Geneva, World Health Organization, 1998 (document WHO/RHT/MSM/98.3) (htp://whqlibdoc.
who.int/hq/1998/WHO_RHT_MSM_98.3.pdf, accessed 7 December 2004).
4. Pregnancy, childbirth, postpartum and newborn care: a guide for essential practice.Geneva,World
Health Organization, 2003 (htp://whqlibdoc.who.int/publications/2003/924159084X.pdf, accessed
7 December 2004).
5. Mahomed K. Iron supplementation in pregnancy (Cochrane Review). In: The Cochrane Library,
Issue 4, 2004. Chichester, John Wiley & Sons, 2004.
6. Mahomed K. Iron and folate supplementation in pregnancy (Cochrane Review). In: The Cochrane
Library, Issue 4, 2004. Chichester, John Wiley & Sons, 2004.
7. Mahomed K. Folate supplementation in pregnancy (Cochrane Review). In: The Cochrane Library,
Issue 4, 2004. Chichester, John Wiley & Sons, 2004.
8. Xiong X et al. Anemia during pregnancy and birth outcome: a meta-analysis. American Journal of
Perinatology, 2000, 17:137146.
9. Cuervo LG, Mahomed K. Treatments for iron defciency anaemia in pregnancy (Cochrane
Review).In:The Cochrane Library, Issue 4, 2004. Chichester, John Wiley & Sons, 2004.
Study
(Type & level
of evidence)
Population &
seting
Objective &
intervention
Outcomes linked to
the standard
Results Comments
13. Sloan,
Jordan &
Winikof 2002
Systematic
review
1++
23randomized
controlledtrials,
15ofwhich
conductedin
developing
countries;the
majoritysetin
antenatalclinics;
only2setinrural
areas;around1000
pregnantwomen
Averagebaseline
haemoglobinlevel
<11g/dl
Toreviewthe
efcacy of iron
supplementation
onhaemoglobin
levelinpregnant
women
Hereresultsrefer
onlytodeveloping
countrystudies
Supplementation
dosagesvaryfrom
<60mg/dayto
>120mg/day,the
majority being >90
mg/day
Haemoglobin
increasebydaily
doseofiron
supplement
Haemoglobin
increaseby
additional efect of
folate
Haemoglobin
increasebyironand
antimalarials
Haemoglobin
increasebyironand
vitaminA
Adherenceto
supplementation
60 mg: + 0.41 (0.027) g/dl
6190 mg: + 0.86 (0.018) g/dl
91120 mg: + 1.87 (0.027) g/dl
>120 mg: + 1.78 (0.042) g/dl
No additional efect of folate
comparedtoironalone(6
studies)
Onlyonesmallstudy:iron
+antimalarialisnotmore
efective than antimalarial
alone
Inonestudythereisadditive
efect
Themajorityofthestudies
reporteditasaproblem
Onlytwostudiesquantify
thisaspect:42%adherence
thatincreases(61%)with
slow-releasegastricdelivery
system;lowadherenceisdue
to side-efects and these are
dose-dependent
Theauthors
questionthe
opportunityof
recommending
large-scale,
publichealth
oraliron
supplementation
programmes
asameans
ofreducing
globalmaternal
anaemiaand
callforfurther
studiesto
determinethe
efectiveness of
otherapproaches
(prevention
ofhookworm
infection,food
fortifcation,
prenatal
prophylactic
treatmentof
falciparum
malaria)
10. Stoltzfus et
al. 1999
Validation
study
945 pregnant
womenand
720 women
at3months
postpartumfrom
ruralarea
Nepal
Tostudythe
association
betweenclinical
pallorasdetected
byhealthworkers
opportunely
trainedand
haemoglobin
concentration
(sensitivityand
specifcity)
Clinical pallor
assessedinthree
sites:inferior
conjunctiva,palm
andnailbed
Twodaysof
training
Haemoglobin10g/dl
sensitivity
specifcity
Haemoglobin 9 g/dl
sensitivity
specifcity
Haemoglobin8g/dl
sensitivity
specifcity
Haemoglobin 7 g/dl
sensitivity
specifcity
Pregnancy
18.2%
94.1%
28%
93.4%
45.8%
92.3%
67.5%
91.5%
3months
postpartum
35.7%
94.3%
51.5%
92.2%
62.7%
89.8%
81.0%
88.1%
Multiplesite
assessment
ishighly
recommended
(increasein
sensitivity
withjustslight
decreaseof
specifcity)
Thisdocument
isnotaformal
publicationof
theWorldHealth
Organization
(WHO),and
allrightsare
reservedbythe
Organization.
Thedocument
may,however,be
freelyreviewed,
abstracted,
reproducedand
translated,inpart
orinwhole,but
notforsalenorfor
useinconjunction
withcommercial
purposes.
contact:
Safer (MPS)
20AvenueAppia
1211 Geneva 27
Switzerland
Tel: +41 22 791 3371
Fax: +41 22 791 5853
Email: MPSinfo@who.int
Chair: Paul Van Look, Director, Department of Reproductive Health and Research;
(Department of Making Pregnancy Safer).
Acknowledgments
This standard was developed by Ornella Linceto with valuable inputs from members of the above
Geneva, 14-16 October 2002. Members of the Center for evaluation of efectiveness of health care-
CeVEAS (Simona di Mario, Vitorio Basevi, Gianfranco Gori, Daniela Spetoli, Dante Baronciani
andNicolaMagrini)developedthetableofevidenceandprovidedadditionalinsightfulreviewof
the evidence section. We thank Bruno Benoist and Mathews Mathai for helpful comments on the
fnal draf, Frank Teckston for the editing and Duke Gyamerah for the layout.
ofitsdevelopment.
Making Pregnancy Safer Department is grateful to the Governments of Denmark, Ireland,
Netherlands, Norway, Sweden, and the United Kingdom, and to the World Bank, UNICEF and
UNFPA for unspecifed programme support.
10. Stoltzfus RJ et al. Clinical pallor is useful to detect severe anemia in populations where anemia is
prevalentandsevere.Journal of Nutrition, 1999, 129:16751681.
11. Lewis SM, Stot GJ, Wynn KJ. An inexpensive and reliable new hemoglobin color scale for
assessinganemia.Journal of Clinical Pathology, 1998, 51:2124.
12. Chowdhury ME et al. Taking a medical history and using a color scale during clinical
examinationofpallorimprovesdetectionofanemia.Tropical Medicine & International Health,2002,
7:133139.
13. Sloan NL, Jordan E, Winikof B. Efects of iron supplementation on maternal hematological status
inpregnancy.American Journal of Public Health, 2002, 92:288293.
14. TorlesseH,HodgesM.Anthelminthictreatmentandhaemoglobinconcentrationsduring
pregnancy.Lancet, 2000, 356:1083. Erratum in: Lancet, 2000, 356:1774. Comment in: Lancet, 2000,
356:2101.
15. van Teilingen E et al. Efectiveness of interventions to promote healthy eating in pregnant women and
women of childbearing age: a review. London, Health Education Authority, 1998:189.
16. Dutra-de-Oliveira JE, de Almeida CA. Domestic drinking water an efective way to prevent
anemiaamonglowsocioeconomicfamiliesinBrazil.Food and Nutrition Bulletin,2002,23:213216.
17. Ballot DE et al. Fortifcation of curry powder with NaFe(111)EDTA in an iron-defcient
population: report of a controlled iron-fortifcation trial. American Journal of Clinical Nutrition,
1989, 49:162169.
18. GarnerP,GlmezogluAM.Drugsforpreventingmalaria-relatedillnessinpregnantwomenand
death in the newborn (Cochrane Review). In: The Cochrane Library, Issue 4, 2004. Chichester, John
Wiley & Sons, 2004.
19. Geerligs PP et al. The efect on haemoglobin of the use of iron cooking pots in rural Malawian
householdsinanareawithhighmalariaprevalence:arandomizedtrial.Tropical Medicine &
International Health, 2003,8:310315.
20. GeerligsPPetal.Acceptabilityoftheuseofironcookingpotstoreduceanemiaindeveloping
countries.Public Health and Nutrition, 2002, 5:619624.
I. Iron defciency anaemia assessment, prevention and control. A guide for programme managers.Geneva,
WorldHealthOrganization,2001(documentWHO/NHD/10.3).
II. Pandav CS et al. Cost of vitamin A and iron supplementation to at risk population. Indian
Journal of Paediatrics, 1998, 65:849856.
III. Fishman SM, Christian P, West KP Jr. The role of vitamins in the prevention and control of anae-
mia.Public Health and Nutrition,2000,3:125150.
for Maternal and
Neonatal Care
Standards
Requirements
Nationalandlocalpoliciessupportallpregnantwomenhavingaccesstomaternaland
neonatalhealthcare,includingreferralcareregardlessoftheirsocioeconomicsituation
orplaceofresidence.
Thehealthcaresystemensuresthatallhealthcareproviderswhocomeintocontact
withpregnantwomenandtheirfamilieshavethecapacities,includinginterpersonal
communicationandinterculturalskills,tosupportthewomaninpreparingabirthand
emergencyplan.
Thehealthcaresystemensuresthatallpregnantwomenareabletodiscussand
review their writen birth and emergency plan with a skilled atendant, ideally at each
antenatalassessmentbutatleastonemonthpriortotheexpecteddateofbirth.
Anationalorlocallyadaptedcardorhome-basedrecordexiststofacilitatethe
developmentandrecordingofthebirthandemergencyplan.
Nationalandlocalhealtheducationactivitiesareundertakentopromotetheneedfor
allwomentoaccessmaternalandneonatalhealthcare,andforallpregnantwomento
makeabirthandemergencyplanduringpregnancy.
Nationalandlocalactivitiesareinplacetofacilitatecommunityactiontoparticipatein,
or where necessary mobilize, local eforts to ensure the timely transfer of women and
babieswithpregnancy-andbirth-relatedcomplications,especiallyemergencies,toa
facilitythathasthecapacitytomanagesuchcomplicationsoremergencies.
Birth and emergency
preparedness in
antenatal care
All pregnant women should have a writen plan for birth and for dealing
withunexpectedadverseevents,suchascomplicationsoremergencies,
thatmayoccurduringpregnancy,childbirthortheimmediatepostnatal
period, and should discuss and review this plan with a skilled atendant
ateachantenatalassessmentandatleastonemonthpriortotheexpected
dateofbirth.
The standard
Toassistwomenandtheirpartnersandfamiliestobeadequatelypreparedfor
childbirthbymakingplansonhowtorespondifcomplicationsorunexpected
adverseeventsoccurtothewomanand/orthebabyatanytimeduring
pregnancy,childbirthortheearlypostnatalperiod.
Aim
W
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d
H
e
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g
a
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a
t
i
o
n
2
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6
1. 9 Bi r th and emergency preparedness i n antenatal care Standards
Audit
Input indicators
Theproportionofpregnantwomenreceivingantenatalcare.
Theproportionofpregnantwomenwithabirthandemergencyplan.
The proportion of communities where leaders, traditional birth atendants, etc. are promoting
birthandemergencyplansforpregnantwomen.
Theproportionofpregnantwomenandofcommunitymemberswithknowledgeofdanger
signs.
Anationallyorlocallyadaptedcardexistsandisusedfordevelopingabirthandemergency
plan.
Supportingeducationalmaterialsfordevelopingabirthandemergencyplanareavailableand
areinuse.
Outcome indicators
The proportion of births at which a skilled atendant is present.
Theproportionofbirthsatwhichabirthcompanion,designatedbythewoman,ispresent.
Theproportionofwomenwhorecentlygavebirthwhosedeliverytookplacewhereplanned.
Transportisavailabletoreferralfacilities.
Health providers, especially community workers and skilled atendants who come into
contactwithpregnantwomen,theirfamiliesandsupporters,must:
Provideinformationtopregnantwomen,theirfamiliesandthebroadercommunity
onthesignsoflabourandwhentoseekcareifdangersignsappearduringpregnancy,
birthand(forboththewomanandherbaby)thepostnatalperiod.
Supportwomenandtheirfamiliesindevelopingandreviewingthebirthand
emergencypreparednessplan,includinghelpingthemtoidentifyasafeplaceforthe
birth(takingaccountofpersonalandlocalcircumstances)anddecidingontheother
elementsoftheplansuchaschildcareandtransport.
Supportwomen,whenneeded,indiscussingtheplanwiththeirpartnersandfamilies.
Discuss with traditional healers, traditional birth atendants (where they exist ), other
layhealthworkersandcommunityleaderstheneedtopromotethedevelopmentof
birthandemergencyplansduringpregnancy,andpossiblecommunityorgroupaction
tosupportwomenandtheirbabiesinaccessingappropriatecarewhenneeded.
Disseminateinformationinthecommunityondangersignsduringpregnancy,birth
andthepostnatalperiod.
Regularlydiscusswithwomenandcommunityleaderspossiblecommunityaction
and/or plans to mobilize local assets and participate in local eforts for the emergency
transferofwomenandnewborninfantswithpregnancy-orbirth-relatedcomplications.
Identifywomenandfamilieswhohaveaproblemaccessingappropriatepregnancy,
birthorpostnatalcareandtakeactiontohelpthemensureaccessor,wherethisis
notpossible,reportsuchcasestothelocalauthoritiesresponsiblefortheprovisionof
maternalandneonatalcare.
Burden of sufering
Childbirthisanormalphysiologicalprocess
forthemajorityofwomenandaprocessthat,
likeallotherlifeevents,islookeduponwitha
mixtureofanticipationandhappyexpectation.
Studiesindevelopedcountrieshaveshown
apositiveimpactonpregnancyandbirth
outcomeswhenthewomanfeelsincontrolof
theprocessofpregnancyandbirth;making
abirthplanhasbeenshowntofacilitatethis
feelingofself-controlandautonomy.
Historicalevidenceshowsthatnocountry
hasmanagedtobringitsmaternalmortality
ratiobelow100per100000livebirthswithout
ensuring that all women are atended by an
appropriatelyskilledhealthprofessional
duringlabour,birthandtheperiod
immediately aferwards (1).Manyofthe
complicationsthatresultinmaternaldeaths
andmanythatcontributetoperinataldeaths
areunpredictable,andtheironsetcanbeboth
suddenandsevere.Delayinrespondingto
theonsetoflabourandsuchcomplications
hasbeenshowntobeoneofthemajor
barrierstoreducingmortalityandmorbidity
surroundingchildbirth(2).Informationon
howtostayhealthyduringpregnancyandthe
needtoobtaintheservicesofaskilledbirth
atendant, on recognizing signs of the onset of
labour,andonrecognizingdangersignsfor
pregnancy-relatedcomplicationsandwhatto
do if they arise would signifcantly increase the
capacitiesofwomen,theirpartnersandtheir
familiestoremainhealthy,totakeappropriate
stepstoensureasafebirthandtoseektimely
skilledcareinemergencies.Interventionsto
reducetheotherbarrierstoseekingcare,such
astransportcosts,perceptionsofpoorquality
of care and cultural diferences, must also be
addressed.
Twotypesofinterventionsfordeveloping
birth plans were identifed, each emphasizing
a diferent aspect of care. Interventions
thatwereconductedinhigher-resource
countriesfocusedmainlyonthewomans
psychologicalandphysicalcomfort(birth
plan),whilethoseinlower-resourcecountries
tendedtofocusonmeasurestoensurea
safe birth with the appropriate atendant
andtoprepareforemergencies(birth
andemergencypreparedness).Birthand
emergencypreparedness(alsoknownasbirth
preparednessandcomplicationreadiness(3,4))
isconsideredbyWHOandotheragenciesto
beausefulandpracticalinterventionwith
severaladvantages(5).Inparticular,itcan
contributetoincreaseduseofservicesby
assistingwomenandtheirfamiliestoplan
forthenecessarysupport,clothingand
equipmentforthebirth,etc.,andbymaking
womenandtheirpartners/familiesawareof
thepotentialforunexpectedevents(6).
Abirthplan/emergencypreparednessplan
includes identifcation of the following
elements(68):thedesiredplaceofbirth;
the preferred birth atendant; the location of
theclosestappropriatecarefacility;funds
forbirth-relatedandemergencyexpenses;
a birth companion; support in looking afer
thehomeandchildrenwhilethewomanis
away;transporttoahealthfacilityforthe
birth;transportinthecaseofanobstetric
emergency; and identifcation of compatible
blooddonorsincaseofemergency.
Birthpreparednessisnoteasytoachieve.
Manypeopleindevelopingcountrieslive
onlessthanUS$1aday,whichishardly
sufcient for them to feed and clothe
themselvesletaloneputasidemoneyforthe
possibilityofanobstetricemergency.Inrural
areas,thesituationisevenmorecomplex:
eveniftransportation(andthemoneytopay
forit)isavailableinthecaseofanobstetric
emergency,distanceandlackofmaintained
roads may still cause delays sufcient to put
thelifeofthewomanindanger(9).
Although litle empirical evidence exists as
yettoshowadirectcorrelationbetweenbirth
preparednessandreducingmaternaland/or
perinatalmortalityandmorbidity,limited
andsmall-scalestudiessuggestthatthereis
considerable beneft to be gained from this
intervention(912). Given the difculties in
predictingpregnancy-relatedcomplications,
providinginformation,educationandadvice
tothewoman,herfamilyandthecommunity
onseekingnecessarycareisseenasan
importantpartofantenatalcare(5).
Studiesshowthat,whilenoclearrelationship
hasbeenfoundbetweenimprovedknowledge
andincreasedhealth-seekingbehaviour,the
adoptionofnewpracticesassociatedwith
planning (such as seting aside money for
thebirth,transportarrangementsandthe
useofbirthplanningcards)atfamilyand
communitylevelsisencouraging(9).
Rationale
Thepresenceofapersonofthewomans
ownchoicetoprovidesocialsupportduring
childbirthhasalsobeenshowntohavea
positive efect (13,14).Thus,animportantpart
ofpreparingforbirthisseekingcontactwith
andobtainingtheservicesofaskilledbirth
atendant. Developing a birth plan can assist
thewomantodecidewhereshewishesto
give birth and which atendant she feels most
comfortablewith.
Birthplanshavebeenusedbymanywomen
inanumberofdevelopedcountriesformore
than a decade, with diferent and sometimes
conficting results (1517).Thereisalso
evidencethatsuchplanningforbirthcanbe
used in other setings, including low-resource
setings (18)butfewstudieshaveexamined
the efectiveness of these interventions and
existing studies are fawed owing to study
andsampledesign(19).Nevertheless,inan
unpublishedWHOreview(9),eightprojects
hadencouragingresultsinusingabirthplan/
emergencypreparednessplanasanessential
componentoftheirsafemotherhoodactivities.
Thecurrentconsensusofthoseworkinginsafe
motherhoodisthat,ifpeopleareawareofthe
importanceofhavingcarefromaskilledbirth
atendant, know where to go in an emergency,
andplanaccordinglyforcostsandother
practical maters, it is more likely they will get
thesupporttheyneedinthesecircumstances.
Takingadvantageofantenatalcaretosupport
thewomaninpreparingforbirth,usinghealth
educationphilosophy,holdsmuchpotential
forimprovementsinmaternalandneonatal
health(4).
Thelackofevidencedemonstratinganegative
impactofbirthplans/emergencypreparedness
plans,therightofwomenandfamiliesto
self-determination,andrecognitionofthe
capacitiesofwomenandfamiliestocontribute
signifcantly to maternal and neonatal health
hasledWHOtorecommendthisintervention
asafundamentalcomponentofallantenatal
careprogrammes.Consequently,birthplans/
emergencypreparednessplansareincluded
inthenewWHOantenatalcaremodel(5)
andtheintegratedmanagementofpregnancy
andchildbirth(IMPAC)(6).Ahandbookon
counsellingandcommunicatinginformation
onpregnancy,childbirth,postpartumand
newborncare,includingasessiononhow
besttosupportthewomanandherfamilyto
developsuchaplan,isinpreparation.
Study
(Type & Level
of evidence)
Population &
Seting
Objective &
Intervention
Standard
Results
11.CARE2000
Observational
studies
2
219women,128
whohadgiven
birthinthe
previousyear
andhadbeen
introducedtobirth
planningand91
whohadnotbeen
introducedtobirth
planning
Bangladesh
Toevaluatean
approachto
facilitatebirth
planning
Birthplanning
byfamilies
promotedthrough
interpersonal
communication
andapictorialbirth
planningcard
Savings/generationof
smallemergencyfundat
familylevel
Organizationof
emergencytransport
Preparationfor
emergencyblood
transfusion
Knowledgeof
appropriatehospital
Intervention(N=128)vscontrol(N=91)
95%vs25%
35%vs0%
5%vs0%
40%vs7%
12.The
Communication
Initiative2004
Observational
studies
2
Datacollection
involving
morethan1700
interviewswith
randomlyselected
individuals
toproducea
representative
sample
Indonesia
Useofradio,
television,print
materials,special
eventsandtraining
programmesto
reachIndonesian
familiesand
communitieswith
theconceptofbeing
alert(siaga)to
emergenciesduring
childbirth
Womenawareof
bleedingasan
indicativedangersign
duringpregnancy
Womenreportedusing
askilledproviderfor
childbirth
Exposedvsnon-exposed
40.7%vs16.4%
67.0%vs44.2%
References
1. VanLerbergheW,DeBrouwereV.Ofblindalleysandthingsthathaveworked:historysles-
sonsonreducingmaternalmortality.In:DeBrouwereV,VanLerbergheW,eds.Safe mother-
hood strategies: a recent review of the evidence.Antwerp,ITGPress,2001:733.
2. ThaddeusS,MaineD.Toofartowalk:maternalmortalityincontext.Social Science and
Medicine,1994,38:10911110.
3. Improving safe motherhood through shared responsibility and collective action. The Maternal and
Neonatal Health Program accomplishments and results,20022003.Baltimore,MD,JHPIEGO,
2003:1116 (htp://www.mnh.jhpiego.org/resources/mnhrev03.pdf, accessed 29 January 2005).
4. Birth preparedness and complication readiness: a matrix of shared responsibilities.Baltimore,MD,
Maternal and Neonatal Health Program, 2001 (htp://www.mnh.jhpiego.org/resources/
bpcrmatrix.PDF,accessed29January2005).
5. WHO antenatal care randomized trial: manual for the implementation of the new model.Geneva:
World Health Organization, 2001 (document WHO/RHR/01.30) (htp://www.who.int/repro-
ductive-health/publications/RHR_01_30/RHR_01_30_contents.en.html,accessed29January
2005).
6. Pregnancy, childbirth, postpartum and newborn care: a guide for essential practice.Geneva,World
Health Organization, 2003 (htp://whqlibdoc.who.int/publications/2003/924159084X.pdf, ac-
cessed7December2004).
7. MooreKM.Safer motherhood 2000. The Communication Initiative, 2000 (htp://www.com-
minit.com/misc/safer_motherhood.html,accessed29January2005).
8. SantarelliC.Working with individuals, families and communities to improve maternal and newborn
health.Geneva,WorldHealthOrganization,2003.
I. AbouZahrC.Antenatal care in developing countries: promises, achievements and missed opportunities:
an analysis of trends, levels and diferentials,19902001.Geneva,WorldHealthOrganization,2003
(htp://whqlibdoc.who.int/publications/2003/9241590947.pdf, accessed 29 January 2005).
Thisdocument
isnotaformal
publicationof
theWorldHealth
Organization
(WHO),and
allrightsare
reservedbythe
Organization.
Thedocument
may,however,be
freelyreviewed,
abstracted,
reproducedand
translated,inpart
orinwhole,but
notforsalenorfor
useinconjunction
withcommercial
purposes.
contact:
Safer(MPS)
20AvenueAppia
1211Geneva27
Switzerland
Tel:+41227913371
Fax:+41227915853
pregnancy_safer/publications/en
Acknowledgments
This standard was developed by Della Sherrat with valuable inputs from members of the above
Geneva, 14-16 October 2002. Members of the Center for evaluation of efectiveness of health
insightfulreviewoftheevidencesection.WethankFrankTeckstonfortheeditingand
ofitsdevelopment.
Netherlands,Norway,Sweden,andtheUnitedKingdom,andtotheWorldBank,UNICEFand
UNFPA for unspecifed programme support.
9. KureshyN,LashleyK.Review of selected family & community practices for safe motherhood.Geneva,
WorldHealthOrganization,2000(unpublisheddocument).
10. PerreiraMetal.Increasingawarenessofdangersignsinpregnancythroughcommunityand
clinic-basededucationinGuatemala.Maternal and Child Health Journal,2002,6:1928.
11. CARE Bangladesh Safe Motherhood project evaluation report.Dhaka,CARE,2000.
12. Programme experiences. SIAGA Campaigns Indonesia. The Communication Initiative, 2004 (htp://
www.comminit.com/pds62004/sld-10291.html,accessed29January2005).
13. MooreM,HopperU.Dobirthplansempowerwomen?Evaluationofahospitalbirthplan.Birth,
1995,22:2936.
14. WhitfordHM,HillanEM.Womensperceptionsofbirthplans.Midwifery,1998,14:248253.
15. Hodnet ED et al. Continuous support for women during childbirth (Cochrane Review). In: The
Cochrane Library, Issue 1, 2005.Chichester,JohnWiley&Sons,2005.
16. Birth rights: new approaches to safe motherhood.London,PanosInstitute,2001.
17. EkeochaCE,JacksonP.Thebirthplanexperience.British Journal of Obstetrics and Gynaecology,
1985,92:97101.
18. HarrisonMJetal.Womenssatisfactionwiththeirinvolvementinhealthcaredecisionsduringa
high-riskpregnancy.Birth,2003,30:109115.
19. LundgrenI,BergM,LindmarkG.Isthechildbirthexperienceimprovedbyabirthplan?Journal
of Midwifery & Womens Health,2003,48:322328.

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