A Suggested Approach for Implementing
CONSORT Guidelines Specific to
Obstetric Research
Suneet P. Chauhan, MD, Sean C. Blackwell, MD, and George R. Saade, MD, for the Society for Maternal-
Fetal Medicine Health Policy Committee
The conduct and reporting of randomized controlled
trials (RCTs) are enhanced by being compliant with the
CONsolidated Standards of Reporting Trials (CONSORT)
statement. The statement was meant to be general and
was aimed at most RCTs without any particular focus on
specific groups of patients. However, research in preg-
nancy presents important unique issues and challenges
that are not addressed in the CONSORT statement. Thus,
we suggest that there is a need to amend the statement
to address RCTs enrolling pregnant or postpartum
women. We propose CONSORT-OB (OBstetrics), with
more than 30 modifications to the current statement. We
hope the CONSORT group would consider our proposal,
and we respectfully suggest that investigators incorpo-
rate these additional data into their reporting of RCTs
involving pregnant or postpartum women.
(Obstet Gynecol 2013;122:952–6)
DOI: 10.1097/AOG.0b013e3182a9c9af
See related editorial on page 943.
From the Department of Obstetrics and Gynecology, Eastern Virginia Medical
School, Norfolk, Virginia; and the Division of Maternal-Fetal Medicine,
Department of Obstetrics, Gynecology, and Reproductive Sciences, UT Health-
University of Texas Medical School at Houston, Houston, and the Department of
Obstetrics and Gynecology, University of Texas Medical Branch, Galveston,
Texas.
The authors thank the members of the SMFM Health Policy Committee for
critical review of manuscript and important inputs. The members of the commit-
tee are Joanne Armstrong, William Grobman, Andrew Helfgott, Dan O’Keeffe,
Carolina Reyes, Kathryn Schubert, Cathy Spong, and Sindhu Srinivas.
Corresponding author: Suneet P. Chauhan, MD, 845 Fairfax Avenue, Suite
544, Norfolk, VA 23507; e-mail: chauhasp@evms.edu.
Financial Disclosure
The authors did not report any potential conflicts of interest.
© 2013 by The American College of Obstetricians and Gynecologists. Published
by Lippincott Williams & Wilkins.
ISSN: 0029-7844/13
952 VOL. 122, NO. 5, NOVEMBER 2013
I n 1996, the CONsolidation of Standards for Report-
ing Trials (CONSORT) statement was developed
to improve the quality of randomized clinical trials
(RCTs).1 Adherence to the guidelines in the state-
ment is associated with improvement in the quality
of the RCTs.2 Over time, the CONSORT statement
has been modified and appended to enhance the
planning, implementation, and reporting of RCTs.3,4
A modification of the statement has also been pro-
posed for RCTs involving children.5 Similarly, we
believe that modification of the CONSORT state-
ment to account for RCTs involving pregnant
women (Table 1) is warranted for several reasons.
In trials enrolling pregnant women, there are two
patients involved: mother and fetus. In some cases,
the risks and benefits of proposed interventions are
not always the same, nor in the same direction, for
both patients. In addition, ethical considerations,
informed consent requirements, and risk-benefit
issues are often more complex than in nonpregnant
populations (eg, vulnerable patient status). Preg-
nancy is associated with dynamic physiologic and
anatomic changes in multiple organ systems, which
have implications for diagnostic, preventive, and
therapeutic approaches. As such, these changes can
significantly affect trial design, implementation, and
results, and should be addressed in the planning and
reporting phases. Pregnancy outcomes and compli-
cations are influenced by a number of factors, such as
maternal age, parity, plurality (singleton compared
with multiple), race or ethnicity, body mass index,
gestational weight gain, obstetric history, medical
comorbidities, gestational age at delivery, and neonatal
gender. When applicable, these important variables
should be included in the analysis and reporting.
Maternal and fetal and neonatal effects of interven-
tions may have long-term implications, including
OBSTETRICS & GYNECOLOGY
Table 1. CONSORT-OB (OBstetrics)

Section and Topic CONSORT 20104 Suggested Additions

Title and abstract 1a Identification as a randomized trial in the title State whether study was during pregnancy or
postpartum time period
1b Structured summary of trial design, methods, If during pregnancy, then state gestational age or
results, and conclusions trimester of recruitment and intervention
Introduction
Background and 2a Scientific background and explanation of Describe knowledge gap regarding RCTs in
objective rationale obstetric population
State whether data available from nonpregnant
population are applicable to pregnant women
Describe whether there are differences in the
efficacy, effectiveness, or safety profile of
the intervention(s) being studied between the
nonpregnant population and pregnant women
Describe the potential risk and benefit profiles for
mother and fetus, including whether they are in
similar direction or competing
Include any systematic reviews on the topic,
specifically in OB
For drug studies, describe the current status of
pharmacokinetics and pharmacodynamics
specific to pregnancy and any likely differences
between the nonpregnant population and
pregnant women; include information regarding
fetal or neonatal exposure and safety profiles for
fetus or neonate
Address effect of these medications on lactation if
postpartum women are included
2b Specific objectives or hypotheses
Methods
Trial design 3a Description of trial design (such as parallel, Report whether a data safety monitoring plan or
factorial) including allocation ratio board was established and the salient
information regarding how they addressed safety
(interim analyses, stopping rules, and others)
3b Important changes to methods after trial
commencement (such as eligibility criteria), with
reasons
Participants 4a Eligibility criteria for participants Provide data on maternal demographics, baseline
characteristics, and obstetric history that
influence outcome
Specify gestational age or postpartum period for
enrollment and intervention
Specify fetal plurality
Provide definitions and diagnostic criteria for all
obstetric independent variables or outcomes
(eg, preterm birth, preeclampsia)
4b Settings and locations where the data were Specify how patients were identified, as well as
collected where and when they were screened, recruited,
and consented (prenatal clinics, labor and
delivery, postpartum floor)
Interventions 5 The interventions for each group with sufficient Provide a rationale for the intervention in the
details to allow replication, including how and control group (placebo, no intervention, and
when they were actually administered others)
Where applicable, describe preconception,
antepartum, intrapartum, and postpartum care
For drug trials, specify dose and any adjustments
for pregnancy, and provide rationale
Outcomes 6a Completely defined prespecified primary and Provide gestational age-specific and plurality-
secondary outcome measures, including how specific outcomes
and when they were assessed
(continued )

VOL. 122, NO. 5, NOVEMBER 2013 Chauhan et al Obstetric Randomized Clinical Trials 953
Table 1. CONSORT-OB (OBstetrics) (continued )
Section and Topic CONSORT 20104 Suggested Additions

Important clinical outcomes specific to pregnancy

should be included and detailed (preterm labor,
fetal growth restriction, preterm birth)
If placental findings are included, then provide
method or reference for sample collection,
processing, and evaluation
Specify whether it is known if outcomes or
variables collected and analyzed, including
psychologic instruments, are affected by
pregnancy, and how it was accounted for
Define the possible harms specific to mother and
fetus
Define plans for maternal and neonatal follow-up;
if only immediate follow-up is planned, then
specify why
6b Any changes to trial outcomes after the trial
commenced, with reasons
Sample size 7a How sample size was determined If there is potential for conflicting maternal
compared with fetal benefit and harm, then
provide the power to detect clinically significant
adverse outcomes for the one (mother or fetus)
who is disadvantaged by the intervention
7b When applicable, explanation of any interim
analyses and stopping guidelines
Randomization
Sequence generation 8a Method used to generate the random allocation
sequence
8b Type of randomization; details of any restriction
(such as blocking and block size)
Allocation 9 Mechanism used to implement the random
concealment allocation sequence (such as sequentially numbered
mechanism containers) describing any steps taken to conceal
the sequence until interventions were assigned
Implementation 10 Who generated the random allocation
sequence, who enrolled participants, and who
assigned participants to interventions
Blinding 11a If performed, who was blinded after
assignment to interventions (for example,
participants, care providers, those assessing
outcomes) and how
11b If relevant, description of the similarity of
interventions
Statistical method 12a Statistical methods used to compare groups Describe and account for potential effect modifiers
for primary and secondary outcomes specific to pregnancy (eg, gestational age,
gestational weight gain, and fetal plurality)
In case the study includes multiple gestations,
specify whether the pregnancy or the fetus is the
unit of analysis, and for the latter specify the
statistical method used to address the
interdependence of the fetuses
12b Methods for additional analyses, such as
subgroup analyses and adjusted analyses
(continued )

954 Chauhan et al Obstetric Randomized Clinical Trials OBSTETRICS & GYNECOLOGY

Table 1. CONSORT-OB (OBstetrics) (continued )
Section and Topic CONSORT 20104 Suggested Additions

Results
Participant flow (a 13a For each group, the numbers of participants Specify whether the numbers provided refer to the
diagram is strongly who were randomly assigned, received intended pregnancy or the fetus or neonate
recommended) treatment, and were analyzed for the primary Compare those who were included to those who
outcome were not, particularly for obstetric variables
13b For each group, losses and exclusions after
randomization, together with reasons
Recruitment 14a Dates defining the periods of recruitment
and follow-up
14b Why the trial ended or was stopped
Baseline data 15 A table showing baseline demographic and Baseline demographic and clinical characteristics
clinical characteristics for each group of each group, including obstetric history and
outcomes as applicable (route of delivery,
complications, and others)
Report gestational age at enrollment, at
intervention, and at delivery
Numbers analyzed 16 For each group, number of participants
(denominator) included in each
analysis and whether the analysis was by original
assigned groups
Outcomes and 17a For each primary and secondary outcome, results
estimation for each group and the estimated effect size and its
precision (such as 95% confidence interval)
17b For binary outcomes, presentation of both
absolute and relative effect sizes is
recommended
Provide any gender effect for neonatal outcomes
If applicable, neonatal outcomes at least until
discharged from hospital or until 28 d should be
provided
Ancillary analysis 18 Results of any other analyses performed,
including subgroup analyses and adjusted
analyses, distinguishing prespecified from
exploratory
Harms 19 All important harms or unintended effects in Report all important maternal and neonatal adverse
each group events or side effects in each intervention group
If there is potential for intervention to influence the
newborn’s health, then plans for follow-up at age
2–4 y should be made
Discussion
Limitations 20 Trial limitations, addressing sources of potential Discuss results within context of risks and benefits
bias, imprecision, and, if relevant, multiplicity of to mother and fetus or neonate, including long-
analyses term
Generalizability 21 Generalizability (external validity, applicability) Provide potential risks to mother and child that
of the trial findings were not addressed in the trial (eg, long-term
outcomes)
Interpretation 22 Interpretation consistent with results, Describe any effects that may be specific to
balancing benefits and harms, and considering particular gestational age or pregnancy
other relevant evidence subgroups
If immediate or intermediate newborn outcomes
are used (eg, Apgar score, umbilical cord pH,
birth weight, short-term survival), then put results
in context of the potential longer-term health
outcomes (eg, intact survival,
neurodevelopmental testing)
(continued )

VOL. 122, NO. 5, NOVEMBER 2013 Chauhan et al Obstetric Randomized Clinical Trials 955
Table 1. CONSORT-OB (OBstetrics) (continued )
Section and Topic CONSORT 20104
Other information
Registration 23 Registration number and name of trial registry
Protocol 24 Where the full trial protocol can be accessed, if
available
Funding 25 Sources of funding and other support (such as
supply of drugs), role of funders
CONSORT, CONsolidated Standards of Reporting Trials; CONSORT-OB (OBstetrics), CONsolidated Standards of Reporting Trials–Obstet-
rics; RCT, randomized controlled trial; OB, obstetrics.
potential reproductive effects for the mother and devel-
opmental outcomes for the newborn. Management
decisions and concurrent interventions outside the
one being studied may have significant confounding
effect during pregnancy and the neonatal period.
Similar to the SPIRIT (Standard Protocol Items:
Recommendations for Interventional Trials) guidance,
which was meant to improve the content and quality of
clinical trial protocols,6 we believe that adding and im-
plementing criteria specific for obstetric research within
the CONSORT guidelines, a modified CONSORT-OB
(OBstetrics), will enhance the reporting as well as the
planning, design, conduct, and analysis of RCTs involv-
ing pregnant women (Table 1). Previously, we identified
32 RCTs that were cited for level A recommendations
in American College of Obstetricians and Gynecolo-
gists practice bulletins that were published after the ini-
tial CONSORT statement in 1996.7 Of these 32 trials,
only 4 (12%) RCTs were 90% or more compliant with
the CONSORT statement.8–11 We ascertained the com-
pliance of these four RCTs with our modification of
CONSORT and noted that overall they included only
43% (range, 37–56%) of our suggestions. Thus, even the
most CONSORT-compliant obstetric RCTs incorpo-
rated only approximately one-third to one-half of our
proposed modifications.
We believe these changes will significantly
improve the quality and safety of obstetric RCTs,
which will lead to greater effect of these trials on the
health of pregnant women and their offspring. More-
over, appropriate reporting of these trials will allow
more effective implementation into clinical practice
and inform applicability to health policy decisions. We
hope the CONSORT group would consider our pro-
posal, and we respectfully suggest that investigators
incorporate these additional data into their reporting of
RCTs involving pregnant or postpartum women.
956 Chauhan et al Obstetric Randomized Clinical Trials
Suggested Additions
REFERENCES
1. Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I,
et al. Improving the quality of reporting of randomized con-
trolled trials: the CONSORT statement. JAMA 1996;276:
637–9.
2. Moher D, Jones A, Lepage L; for the CONSORT Group. Use
of the CONSORT statement and quality of reports of random-
ized trials a comparative before-and-after evaluation. JAMA
2001;285:1992–5.
3. Schulz KF, Altman DG, Moher D, Fergusson D. CONSORT
2010 changes and testing blindness in RCTs. Lancet 2010;375:
1144–46.
4. Schulz KF, Altman DG, Moher D; CONSORT Group. CON-
SORT 2010 statement: updated guidelines for reporting parallel
group randomized trials. Obstet Gynecol 2010;115:1063–70.
5. Saint-Raymond A, Hill S, Martines J, Bahl R, Fontaine O,
Bero L. CONSORT 2010. Lancet 2010;376:229–30.
6. Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H,
Berlin JA, et al. SPIRIT 2013 explanation and elaboration:
guidance for protocols of clinical trials. BMJ 2013;346:
e7586.
7. Chauhan SP, Berghella V, Sanderson M, Siddiqui D,
Hendrix NW, Magann EF. Randomized clinical trials behind
level A recommendations in obstetric practice bulletins: com-
pliance with CONSORT statement. Am J Perinatol 2009;26:
69–80.
8. Mercer BM, Miodovnik M, Thurnau GR, Goldenberg RL,
Das AF, Ramsey RD, et al. Antibiotic therapy for reduction
of infant morbidity after preterm premature rupture of mem-
branes: a randomized control trial. JAMA 1997;278:989–95.
9. Ober C, Karrison T, Odem RR, Barnes RB, Branch DW,
Stephenson MD, et al. Mononuclear-cell immunization in pre-
vention of recurrent miscarriages: a randomized trial. Lancet
1999;354:365–9.
10. The Canadian Early and Midtrimester Amniocentesis Trial
(CEMAT) Group. Randomized trial to assess safety and fetal
outcome of early and mid-trimester amniocentesis. Lancet
1998;351:242–7.
11. Levine RJ, Hauth JC, Curet LB, Sibai BM, Catalano PM,
Morris CD, et al. Trail of calcium to prevent preeclampsia.
N Engl J Med 1997;337:69–76.
OBSTETRICS & GYNECOLOGY