European Journal of Obstetrics & Gynecology and Reproductive Biology 263 (2021) 117–126

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European Journal of Obstetrics & Gynecology and

Reproductive Biology
journal homepage: www.elsevier.com/locate/euro

Full length article

Development of a core outcome set for effectiveness studies of

breech birth at term (Breech-COS): A systematic review on
variations in outcome reporting
Shawn Walker a,⇑, Tisha Dasgupta a, Alexandra Halliday a, Anke Reitter b
a
King’s College London, Department of Women and Children’s Health, London SE1 7EH, United Kingdom
b
Obstetric and Prenatal Medicine Department, Hospital Sachsenhausen, Academic Teaching Hospital of the Goethe-University Frankfurt, Schulstrasse 31, 60594 Frankfurt, Germany

a r t i c l e i n f o a b s t r a c t

Article history: Women pregnant with a breech-presenting fetus at term are at an increased risk of adverse outcomes.
Received 31 March 2021 Although the most common intervention is planned delivery by caesarean section, this is not always
Revised 12 June 2021 possible or desirable. Comparing alternative interventions is difficult due to heterogeneity in reported
Accepted 17 June 2021
outcomes and their measurements. Additionally, the evidence, particularly for women in labour with a
breech-presenting fetus, is very low quality, with several outcomes viewed as critical and important to
decision-making not reported at all. There is a need to develop a core outcome set of minimum outcomes
Keywords:
in all studies evaluating the effectiveness of interventions to improve outcomes associated with term
Consensus
Core outcome set
breech birth (Breech-COS).
Systematic review Our objectives were to (1) identify outcomes currently reported in effectiveness studies of breech birth
Delphi at term using a systematic review of the literature; (2) assess the methodological quality of outcome
Breech presentation reporting in the included studies; and (3) engage with members of an established Patient and Public
Clinical trial Involvement (PPI) group about the results, to help frame our understanding from the perspective of ser-
vice users.
We searched three databases (MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials)
for all effectiveness studies associated with vaginal breech birth published in English between 2000
and 2020. Two reviewers independently screened and extracted the data. Outcomes were categorised
into neonatal, maternal, features of labour, and long-term maternal and hierarchy of outcome classifica-
tion (primary, secondary, part of composite, or undesignated). Frequency of reporting was calculated for
each. An adapted methodological assessment was done for each study investigating whether primary and
secondary objectives were clearly stated and defined. The results of the systematic review were then dis-
cussed with a PPI group to consider importance and relevance to service users.
A total of 211 outcomes were extracted from 108 included studies, comprising of short (43) and long-
term (39) neonatal, short (54) and long-term (39) maternal and features of labour (36) outcomes. The
most frequently reported outcome in each category was: APGAR score at 5 min, developmental vulner-
ability/neurological morbidity, maternal mortality, urinary incontinence, and actual mode of birth
respectively. Long-term outcomes were infrequently reported in the included studies, with outcomes
for future pregnancies not reported at all, although these were each deemed important by service users.
There was a lack of consensus in definition and measurement of outcomes, with only 36% of the included
studies having clearly stated primary and secondary objectives.
The observed heterogeneity in reported outcomes, lack of consensus in definition and measurement, as
well as desire expressed by service users to have robust risk statistics for outcomes important to them
highlights the need to develop a core outcome set for evaluating effectiveness studies of breech birth
at term. A Breech-COS will enable useful synthesis of evidence and contribute to supported decision-
making for women pregnant with a breech-presenting fetus at term.
Ó 2021 Elsevier B.V. All rights reserved.

⇑ Corresponding author.
E-mail addresses: Shawn.Walker@kcl.ac.uk (S. Walker), Tisha.Dasgupta@kcl.ac.uk (T. Dasgupta), areitter@khs-ffm.de (A. Reitter).

https://doi.org/10.1016/j.ejogrb.2021.06.021
2215-1532/Ó 2021 Elsevier B.V. All rights reserved.
S. Walker, T. Dasgupta, A. Halliday et al. European Journal of Obstetrics & Gynecology and Reproductive Biology 263 (2021) 117–126

Nomenclature

CROWN Core Outcomes in Women’s and Newborn Health

Abbreviations and Definitions D+C Dilation and curettage
APH Antepartum haemorrhage DAMP Deficits in attention, motor control, and perception
ARDS Acute respiratory distress syndrome DIC Disseminated intravascular coagulation
Breech Refers to a foetus, lying in a longitudinal position, with DVT/PE Deep vein thrombosis/pulmonary embolism
buttocks, feet, or knees closest to the cervical os (bottom ECV External cephalic version
of the uterus) IQ Intelligence quotient
Breech-COS Core outcome set for evaluation of studies of breech NEC Necrotising enterocolitis
birth at term NICU Neonatal intensive care unit
CS Caesarean section PPH Post-partum haemorrhage
CENTRAL Cochrane Central Register of Controlled Trials PPI Public and patient involvement
COMET Core Outcome Measurement in Effectiveness Trials PSC Project steering committee
COS Core outcome set Term Refers to a term pregnancy, defined as a gestation great-
CPAP Continued air pressure pathway er than 36 weeks 5 days and less than 42 weeks 0 days
VBB Vaginal breech birth

Introduction stakeholders for consensus development. Breech-COS is part of a

larger project that seeks to evaluate an alternative model of care,
Women pregnant with breech presenting foetus at term are at ‘‘The OptiBreech care pathway: evaluating the feasibility and
an increased risk of adverse pregnancy outcomes [1]. Planned acceptability of team care for women seeking to plan a vaginal
delivery by caesarean section (CS) is the most common interven- breech birth” (NIHR 300582).
tion used to improve neonatal outcomes [2]. However, prior plan- Breech-COS has been registered with the COMET Initiative
ning is not always possible, and some women may prefer to give (www.comet-initiative.org; #1749) and has been submitted to
birth vaginally. Although alternative interventions have been pro- the CROWN Initiative.
posed by many providers, heterogeneity in the reported outcomes
[3] acts as a barrier to meaningful comparisons. Careful selection of
Objectives
primary and secondary outcomes is a crucial component of clinical
trial design [4]. Heterogeneity in outcomes measured within the
The overall aim of Breech-COS is to identify a core outcome set
same clinical area, including inconsistency about the broad
for effectiveness studies of breech birth at term by an international
domains considered, the outcomes themselves, the way these out-
multi-stakeholder consensus method. Breech-COS is intended as
comes are labelled and defined, and the methods and timing of
the international standard for randomised and non-randomised
measurement, can complicate or prevent useful synthesis and
effectiveness studies of breech births in term pregnancies. This
meta-analysis [5]. Standardised reporting of outcomes and their
review is the first stage of the Breech-COS development. The speci-
measurement enables the direct comparison of effects of different
fic objectives are in accordance to the four steps of developing a
interventions across multiple studies, thereby improving the qual-
COS, as outlined by the COMET Initiative, namely: (1) conceptual
ity of research and minimising bias [4].
considerations, (2) finding existing outcome measurement instru-
This literature review was the first step in developing a core
ments using a systematic review, (3) quality assessment of existing
outcome set (COS), the first for studies evaluating effectiveness of
instruments, and (4) recommendations for selection of outcomes
interventions to improve outcomes in breech births at term, to be
included in COS using a consensus process [6].
titled Breech-COS. A COS is a minimum set of key standardised out-
The primary objective of this systematic review was:
comes, agreed upon by all relevant stakeholders, that should be
measured and reported in all trials for the specific clinical field
1. To identify outcomes currently reported in comparative studies
[6]. The Cochrane Collaboration [5], the Core Outcome Measure-
concerning breech birth at term by way of a systematic review
ment in Effectiveness Trials (COMET) Initiative [6], and the Core
of the literature.
Outcomes in Women’s and Newborn Health (CROWN) Initiative
[7] all recommend developing a COS to improve synthesis of evi-
The secondary objectives were:
dence. Conducting a systematic review of outcomes is an efficient
way to identify an inclusive list of outcomes being reported by
1. To identify the methodological quality of outcome reporting in
researchers in the field [6]. Additionally, outcomes reported in tri-
existing studies; and
als may not be meaningful endpoints for service users [4]. There-
2. To engage with members of an established Patient and Public
fore, the COMET Initiative recognises that COS need to include
Involvement (PPI) group about the results, to help frame our
outcomes that are important to patients and carers, in order for
understanding from the perspective of service users
care to be person-centred, and recommend incorporating Public
and Patient Involvement (PPI) groups in COS development [6].
We undertook a systematic literature review to identify out- Methods
comes, definitions and measurements previously reported in effec-
tiveness studies of breech births at term and involved the study’s Search strategy and selection criteria
PPI group to discuss their importance to service users, as a prelim-
inary exercise to formal participation in the Breech-COS Delphi The methods and criteria for study selection were developed in
survey. The results of this review will be included in the interna- accordance with the scope of Breech-COS, and in consultation with
tional Delphi survey for Breech-COS and will be open to all key the research team as well as the Project Steering Committee (PSC),
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S. Walker, T. Dasgupta, A. Halliday et al.
which includes breech-experienced obstetricians, midwives and
service users. The databases searched were EMBASE, MEDLINE,
and Cochrane Central Register of Controlled Trials (CENTRAL). Full
terms of a comprehensive, electronic search strategy are included
in the supplementary material (Supplementary Material 1).
The eligibility criteria were designed to identify the choice and
consistency of outcomes reported in comparative studies concern-
ing vaginal breech birth (VBB). Studies not describing breech birth
outcomes, conference proceedings or abstracts without complete
trial description were not included. Eligible participants were all
childbearing people  37 weeks pregnant with a foetus in breech
presentation. Eligible interventions included planned modes of
delivery (planned VBB vs. planned CS), methods of management
for VBB (upright vs. supine, expediated vs. conservative, assisted
delivery), and models of care delivery (different experience levels,
professions, breech teams).
The eligibility criteria were:
 Settings: both high- and low-income
 Language: English language,
 Time: 2000 to 2020
 Study design: systematic reviews, randomised trials, compara-
tive observational studies
The time period was chosen as the ‘Term Breech Trial’, a single
large randomised trial, was published in 2000 [8]. Two other small
trials completed before 2000 are included in the Cochrane Review
last updated in 2015 [2]. The scoping search revealed no other tri-
als in this time period.
Two of the four review authors (SW, AH, AR, TD) independently
screened the title and abstracts returned by the search strategy,
followed by full-text screening to determine eligibility. A third
reviewer was consulted to moderate and resolve disagreements,
in cases of discrepancy. Covidence systematic review software [9]
was used to record the screening process. Independent data extrac-
tion was then performed for each article using a Microsoft Excel
spreadsheet-based extraction form for the following: author and
title details, year and journal of publication, study type, setting,
key eligibility criteria, study population size, description of inter-
vention, proposed outcomes, primary and secondary effectiveness
and safety outcome(s) reported, outcome definition(s), outcome
measurement tool(s) and timing(s). Original study authors were
contacted in cases of unclear or unavailable data.
Outcomes were categorised into measures associated with each
of the five following: short- and long-term neonatal, short- and
long-term maternal, and features of labour. Frequency of reporting
for each outcome was calculated, and each was designated as a pri-
mary, secondary, part of a composite, or reported but not desig-
nated; as per the outcome framework by the COMET Initiative [6].
For the features of labour outcome group, an additional designation
of group was also assigned, if the measure acted as a subject group in
the study. The subsequent Delphi survey for prioritisation of out-
comes by stakeholders will also be informed by these categories.
Assessment of methodological quality
The methodological quality of reported outcomes in included
studies were assessed using the four questions as below [6,10] rather
than performing a traditional assessment of individual studies.
1. Is the primary outcome clearly stated?
2. Is the primary outcome clearly defined so that another
researcher would be able to reproduce its measurement (e.g.,
measurement tools, measurement timing)?
3. Are secondary outcomes clearly stated?
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European Journal of Obstetrics & Gynecology and Reproductive Biology 263 (2021) 117–126
4. Are secondary outcomes clearly defined?
A scoring system was devised where each article was scored
from 1 to 4 depending on how many of the questions were
answered. The frequency of each quality score was then calculated.
PPI group involvement
The summary of findings from the systematic review were
brought to the OptiBreech study’s pre-established PPI group in an
online meeting led by members of the review team [SW and TD].
The meeting was advertised on the project website (OptiBreech.
uk) as well to invite parents with experience of breech birth. The
purpose of this stage was to gain insight into (1) how service users
with experience of breech birth value the outcomes identified in
published literature, including their importance and relevance;
and (2) to identify any outcome measures that are deemed impor-
tant by the PPI group but were not identified by the systematic
review. This was to enable the PPI group to have significant influ-
ence on the subsequent Delphi process from the start of the survey.
The meeting was recorded, and key themes and points of discus-
sion obtained from the meeting transcript. Understanding was
checked with participants repeatedly during the meeting. No iden-
tifiable information or direct quotes were collected or preserved.
Results
Our search identified 817 records in total, of which 13 were
duplicates and 629 were deemed irrelevant based on title and
abstract screening. Full text was assessed for the remaining 147
articles and 39 were removed due to various reasons such as
full-text not available in English, wrong patient population etc.
Finally, data was extracted for 108 studies, as presented in the
PRISMA flow chart in Fig. 1. The 108 articles included comprised
of reviews with or without meta-analysis, randomised controlled
trials, and non-randomised observational studies from various set-
tings: low-, middle-, and high-income countries; at home birth vs.
tertiary care centre; and comparing various interventions: mode of
delivery (e.g., VBB, external cephalic version, CS), models of service
provision (e.g., staff training levels, hospital birth volume), man-
agement of delivery (e.g., upright position vs. supine, manoeuvres
used, induction), or no intervention. A full record of the character-
istics of each article included in this review is provided in the sup-
plementary material (Supplementary material 2).
Outcomes
We extracted 211 total outcomes, divided into short-term
neonatal (43), long-term neonatal (39), short-term maternal (54),
long-term maternal (39), and features of labour (36). Frequency
of reporting and outcome hierarchy designation for each of these
is provided in detail in Table 1. In the 108 included reviews, the
most frequently reported outcome was mode of birth: vaginal birth
in 93.5%, elective CS in 76.8%, and emergency CS in 72.2% articles.
Some studies compared only vaginal birth vs emergency or elective
CS, but not both; others were concerned with the results of vaginal
births only. However, most studies reported mode of birth as a
subject group, i.e., authors compared various outcomes between
vaginal breech birth vs. elective CS vs. emergency CS.
On average, neonatal outcomes were reported in a more studies
as compared to maternal outcomes (11.1% vs. 3.7%), with very few
reporting long term or salutogenic outcomes for either. Amongst
short-term neonatal outcomes, APGAR score at 5 min was the most
commonly reported outcome, reported in 77.7% studies. This was
followed by perinatal death (67.5%) and admission to NICU
S. Walker, T. Dasgupta, A. Halliday et al.
Fig. 1. PRISMA flow chart of review screening and inclusion process.
(57.4%). The three most reported long-term neonatal outcomes
were developmental vulnerability/special needs/neurological
morbidity (18.5%), cerebral palsy (10.1%) and developmental
delay/learning disability (10.1%).
The most frequently reported short-term maternal outcome
was maternal mortality, measured in 21.2% studies. Postpartum
haemorrhage (14.8%) and requiring blood transfusion (14.8%) were
the next two most frequent. Long-term maternal outcomes were
very rarely reported, with only 6.4% studies having measured uri-
nary, and faecal incontinence each, and 5.5% having reported on
breastfeeding complications.
Planned mode of birth, for intention-to-treat analysis, or actual
mode of birth was reported in 42.5% and 30.5% studies respec-
tively. Induction of labour was also a frequently reported feature
of labour, included in 30.5% studies. The frequency of the top three
most reported outcomes in each category is listed in Table 2.
Methodological quality
Out of 108 included articles, 32 (29.6%) scored 4 i.e., answered
all four of the methodical assessment questions. However, 16 of
these did not analyses any secondary outcomes or objectives. 17
(15.7%) scored 3, 45 (41.6%) scored 2, 6 (5.5%) scored 1, and 8
(7.4%) scored 0 with neither primary nor secondary objectives sta-
ted and defined. Table 3 shows detailed frequencies for each crite-
rion. The primary objective was clearly stated in 47 (43.5%) of 108
included studies. 65 (60.1%) articles defined how the primary out-
come was measured but did not explicitly classify it as a primary or
secondary outcome. Notably, there was a discrepancy observed in
definition and measurement for certain outcomes such as mea-
surement period for perinatal death, or outcomes to include in a
composite of trauma associated morbidity. For the former, there
were 10 different time periods defined, while some left it unde-
fined. Table 4 lists frequency for each of the definitions. 21
(22.2%) of included studies had clearly stated secondary objectives
26/108 (24.1%) studies had defined them. 58/108 (53.7%) did not
European Journal of Obstetrics & Gynecology and Reproductive Biology 263 (2021) 117–126
investigate a secondary objective and did not have any secondary
outcomes listed.
Meeting with PPI group
The PPI group meeting was attended by service users, practicing
midwives, health educators, and breech birth activists. Overall, the
participants emphasised that neonatal risk outcomes should be
provided during consultation, substantiated by robust statistics,
particularly for commonly occurring negative outcomes. Women
prioritised neonatal mortality as measured from the onset of
labour, as they felt this would reflect a difference in risk compared
to cephalic (head-first) birth, rather than with caesarean section.
They emphasised the need for accurate statistics in taking
informed decisions, particularly being able to compare risk of out-
comes in vaginally born breech babies versus those born vaginally
in a head-first position. There was an issue raised of health workers
using hyper-clinical or very emotive language to describe possible
negative outcomes. For example, several PPI members reported
‘head entrapment’ described as an outcome, and although the
image was very emotive, they were unsure what the actual impact
on their baby or themselves would have been had this occurred in
their births.
The time of clamping the baby’s umbilical cord was another
common concern, and mothers agreed that the baby being taken
away immediately was distressing, though no studies reported
timing of umbilical cord clamping nor separation as outcomes. This
was also true for admission to NICU, with mothers reporting that
they needed to know why the baby had to go to the NICU, for
how long, and if they themselves could join. There was agreement
that features of labour outcomes such as rates and risks associated
with induction, manoeuvres used etc. need to be more prominently
reported in general. They also agreed on the importance of measur-
ing long-term maternal outcomes particularly mental health
effects for women and their partners, and rates and outcomes of
future pregnancies. Service users stressed the need for improved
psychological support available to women, to discuss the afteref-
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Table 1
Full list of outcomes with frequency or reporting and categorisation of outcome.

Outcomes Total P S N C
Short-term neonatal
APGAR score at 5 min 84 15 9 46 14
Perinatal mortality (includes intrapartum and/or neonatal only) 73 24 3 37 9
Admission to neonatal intensive care unit (NICU) 62 13 7 29 13
Neonatal birth trauma/morbidity (incl. any of following) 56 11 4 21 20
Brachial plexus injury/peripheral nerve injury 39 7 4 11 17
Low umbilical artery PH 39 5 6 25 3
Bone fracture (clavicle/basal skull/humerus/femur) 36 6 2 12 16
Neonatal seizures/convulsions 32 9 1 7 15
Intubation/ventilation 31 5 1 12 13
Hematoma (cephalo- or subdural- or not specified) 29 6 2 8 13
Composite neonatal outcome 27 13 4 10 0
intracerebral bleeding/laceration or haemorrhage 26 6 2 5 13
APGAR score at 1 min 22 1 1 20 0
Tube feeding 21 6 1 5 9
Spinal cord injury 20 4 1 2 13
Significant genital injury 17 3 0 2 12
Neonatal asphyxia 16 3 2 10 1
Respiratory distress syndrome/meconium aspiration 15 4 1 7 3
Cord blood base deficit 14 5 2 4 3
Hypotonia 13 5 1 2 5
Stupor/decreased response to pain/coma 10 3 0 3 4
Foetal acidaemia/acidosis 9 4 0 4 1
APGAR score at 10 min 8 1 1 6 0
Cord blood base excess 8 1 1 4 2
Admission to intermediate unit 8 2 1 4 1
Difficulty with delivery of after coming head 7 0 0 7 0
Intrauterine Stillbirth 6 1 0 4 1
Hip dislocation 5 0 0 5 0
Low APGAR score 5 0 1 4 0
Assisted ventilation after delivery (greater than30mins) 5 3 0 1 1
Neurologically normal at 6 weeks 5 2 0 3 0
Hyperbilirubinemia 4 1 0 3 0
Other birth injury 3 0 0 2 1
Perinatal infection 3 1 1 1 0
Paresis or paralysis 3 2 0 1 0
Lacerations to baby buttocks 2 0 0 2 0
Transfer to higher service level hospital 2 0 0 1 1
Venous cord blood PH 1 0 0 1 0
Umbilical cord lactate 1 0 1 0 0
External heart massage required at birth 1 0 0 1 0
Neonatal hypoglycaemia 1 0 0 1 0
Surgical procedures 1 0 0 0 1
Jaundice 1 0 0 1 0
Long-term neonatal
Developmentally vulnerable/special needs/neurological morbidity 20 3 3 14 0
Diagnosis of cerebral palsy 11 5 0 6 0
Developmental delay or learning disability (incl. non-verbal cognition, 11 2 1 8 0
social-emotional development, language deficiencies)
Neonatal encephalopathy 8 3 2 3 0
Infant mortality (up to 1 year) 7 1 2 4 0
Congenital malformation/defect 6 0 1 5 0
Speech/language problems 6 1 0 5 0
motor development 5 0 0 5 0
Autism 5 1 0 4 0
Any medical problem at 2 years 5 0 2 3 0
Child follow up in outpatient care/ Hospitalisation 5 1 0 4 0
Epilepsy 4 1 0 3 0
Visual defect 4 1 0 3 0
Auditory defect 4 1 0 3 0
Pedagogical support in school 4 1 0 3 0
Short term problems with breathing/bradycardia 4 1 0 3 0
Hypoxia 4 0 0 4 0
Developmental dysplasia of the hip 3 0 0 3 0
Need for resuscitation 3 0 0 2 1
Continuous Positive Airway Pressure (CPAP) 3 2 0 0 1
Facial palsy 3 1 1 0 1
Childhood mortality 2 1 0 1 0
Deficits in Attention, Motor Control and Perception (DAMP) or DAMP related symptoms 2 0 0 2 0
No unassisted walking 2 0 0 2 0
Pedagogical support in kindergarten 2 1 0 1 0
Speech/language support 2 1 0 1 0
Special childcare support 2 1 0 1 0
Poor infant health (general) 1 1 0 0 0

(continued on next page)

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Table 1 (continued)

Outcomes Total P S N C
Spasticity 1 0 0 1 0
Hyperactivity 1 1 0 0 0
Level of educational attainment 1 0 0 1 0
Necrotizing enterocolitis (NEC) 1 1 0 0 0
Long term medication 1 0 0 1 0
Ordinary childcare support 1 0 0 1 0
Increased childcare support 1 0 0 1 0
Low intelligence quotient (IQ) 1 0 0 1 0
Asthma 1 0 0 1 0
Postponed school start 1 0 0 1 0
Low scores on school tests 1 0 0 1 0
Short-term maternal
Maternal mortality 23 5 3 15 0
PPH requiring blood transfusion 16 3 5 7 1
Genital tract trauma 16 1 4 10 1
Other serious maternal morbidity/other complications 15 1 4 8 2
Wound infection requiring prolonged hospital stay/readmission/antibiotics 13 1 5 6 1
Postpartum haemorrhage (PPH) transfusion not specified 11 0 4 7 0
Deep vein thrombosis/Pulmonary embolism (DVT/PE) requiring anticoagulant therapy 11 0 3 7 1
Prolonged hospital stay 11 1 3 6 1
Gestational Diabetes Mellitus 10 1 0 9 0
Hypertensive disorder/Preeclampsia 9 1 0 8 0
Hysterectomy 8 0 2 4 2
PPH not requiring transfusion 7 0 2 5 0
Vulvar or perineal haematoma requiring evacuation 7 0 3 3 1
Maternal fever of 38.5 or above on two occasions at least 24 h apart not including first 24 h 7 1 3 2 1
Anaemia 6 2 1 3 0
Placental separation/abruption 6 0 0 6 0
Bladder, ureter or bowel injury requiring repair 6 0 1 4 1
Wound dehiscence/breakdown 5 1 1 1 2
Genital tract fistula 5 0 1 3 1
Cystitis/urinary retention/tract infection 5 0 0 4 1
Endometriosis 5 0 1 4 0
Dilation and curettage (D + C) for bleeding/retained placental tissue 4 0 1 2 1
Uterine Rupture 4 0 1 3 0
Puerperal infections 4 0 0 4 0
Pre-existing Diabetes 4 0 0 4 0
Antepartum haemorrhage (APH) 3 0 0 3 0
Cervical laceration involving lower uterine segment 3 0 1 1 1
Acute respiratory distress syndrome (ARDS)/Mechanical ventilation 3 0 1 0 2
Bowel/intestinal obstruction 3 0 1 1 1
Admission to ICU 3 3 0 0 0
Ileus 3 0 0 2 1
Composite maternal outcome 2 0 0 2 0
retained placental tissue/manual removal of placenta 2 0 1 0 1
Vertical uterine incision or serious extension to transverse uterine incision 2 0 1 0 1
Pneumonia 2 0 1 0 1
Readmission 2 0 0 1 1
Wall abscess/postoperative hematomas 2 0 0 2 0
Moderate trauma relating to obstetrical or surgical manoeuvres 2 0 0 2 0
Sepsis 2 2 0 0 0
Endomyometritis 2 0 1 1 0
Postpartum antibiotic treatment 2 0 2 0 0
Intracranial/Cerebrovascular haemorrhage 1 0 0 0 1
Cardiac Arrest 1 0 0 0 1
Isolated hyperthermia 1 0 0 1 0
Pyelonephritis 1 0 0 1 0
Disseminated intravascular coagulation (DIC) 1 0 0 1 0
Intestinal injuries 1 0 0 1 0
Additional Surgery 1 0 1 0 0
Organ Failure 1 1 0 0 0
Hypotension 1 0 0 0 1
Prolonged vaginal bleeding 1 0 0 1 0
Laparotomy 1 0 0 1 0
Relaparotomy 1 0 0 1 0
Early depression 1 0 1 0 0
Long-term maternal
Urinary incontinence 7 3 1 3 0
Faecal incontinence 7 3 1 3 0
Breastfeeding complications 6 3 1 2 0
Postnatal depression 5 2 2 1 0
CS in subsequent delivery 5 2 1 2 0
Long term perineal pain 4 3 1 0 0
Long term abdominal pain 4 3 1 0 0
Dyspareunia 4 3 1 0 0

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Table 1 (continued)

Outcomes Total P S N C
Any pain 4 2 1 1 0
Flatus incontinence 4 2 1 1 0
Relationship with partner 4 2 1 1 0
Subsequent pregnancy 4 1 1 2 0
Maternal satisfaction 4 2 1 1 0
Back pain/back ache 3 2 1 0 0
Relationship with baby 3 1 1 1 0
Uterine rupture in subsequent delivery 3 1 1 1 0
Postnatal anxiety 2 0 1 1 0
Infertility 2 0 1 1 0
Miscarriage or termination in subsequent pregnancy 2 0 1 1 0
Menorrhagia 2 1 1 0 0
Breech presentation in subsequent pregnancy 2 1 0 1 0
Fatigue/tiredness 2 1 0 1 0
Constipation 2 1 0 1 0
Pain during sex 2 1 0 1 0
Had sex in last 36 months 2 1 0 1 0
Happiness with sexual relations 2 2 0 0 0
Ease of caring for child 2 2 0 0 0
Experience of motherhood 2 2 0 0 0
Uterovaginal prolapse 1 0 1 0 0
Postnatal self esteem 1 0 1 0 0
Genital dystopia (characterised by rectovaginal prolapse or enterocele) 1 1 0 0 0
Dysmenorrhea 1 0 1 0 0
Painful menstrual periods 1 1 0 0 0
Irregular menstrual periods 1 1 0 0 0
Haemorrhoids 1 1 0 0 0
Vaginal discharge 1 1 0 0 0
Relationship with partner compared to when baby was born 1 1 0 0 0
Visited doctor since birth 1 1 0 0 0
Childbirth experience 1 1 0 0 0
Outcomes Total P S N C G
Features of labour
Vaginal Breech Delivery 101 12 0 20 0 69
Elective caesarean 83 7 1 16 0 59
Emergency Caesarean 78 9 1 27 0 41
Actual mode of birth 46 7 1 28 0 10
Planned mode of birth 33 2 1 13 0 17
Induction of labour 33 1 0 28 0 4
Trial of labour/ Failure to progress 23 2 0 21 0 0
Manoeuvres used 21 1 0 18 0 2
Instrumental vaginal delivery 20 0 1 19 0 0
Regional anaesthesia 18 0 1 17 0 0
Duration of delivery/second stage 17 0 0 17 0 0
Premature rupture of membranes 17 0 0 17 0 0
Medical staff management/decision/ adherence to TBT 16 0 0 2 0 14
Type of Breech/Maternal characteristics 15 0 0 12 0 3
Augmentation of labour 15 0 0 15 0 0
ECV 15 1 0 8 0 6
Abnormal tracing in labour/Foetal monitoring 14 0 0 12 0 2
Duration of first stage 13 0 0 13 0 0
Umbilical cord prolapse 13 0 0 13 0 0
Vaginal Cephalic Delivery 11 1 0 3 0 7
Maternity unit activity/ Type of hospital 8 0 0 4 0 4
Chorioamnionitis 7 0 0 7 0 0
VBB attempt 6 2 1 1 0 2
General anaesthesia 6 0 1 5 0 0
Cord presentation 5 0 0 5 0 0
Nuchal cord 5 0 0 5 0 0
Maternal choice in mode of delivery (incl. information source/support/safety) 5 0 1 3 0 1
Precipitous labour 3 0 0 3 0 0
Oligohydramnios 3 0 0 3 0 0
Non vertex presentation at birth 2 0 0 2 0 0
Uterine contraction 1 0 0 1 0 0
Antibiotic use in labour 1 0 0 1 0 0
Meconium staining 1 0 0 1 0 0
Meconium aspiration 1 1 0 0 0 0
Colour of amniotic fluid 1 0 0 1 0 0

P-primary; S-secondary; N-undesignated; C-part of composite; G-as a subject group.

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Table 2
Top three most commonly reported outcomes in each category.

Outcome Total P S N C G
Short-term neonatal
APGAR score at 5 min 84 (77.7%) 15 9 46 14
Perinatal mortality (includes intrapartum and/or neonatal only) 73 (67.5%) 24 3 37 9
Admission to NICU 62 (57.4%) 13 7 29 13
Long-term neonatal
Developmentally vulnerable/special needs/neurological morbidity 20 (18.5%) 3 3 14 0
Diagnosis of cerebral palsy 11 (10.1%) 5 0 6 0
Developmental delay or learning disability (incl. non-verbal cognition, social-emotional development, language deficiencies) 11 (10.1%) 2 1 8 0
Short-term maternal
Maternal mortality 23 (21.2%) 5 3 15 0
PPH requiring blood transfusion 16 (14.8%) 3 5 7 1
Genital tract trauma 16 (14.8%) 1 4 10 1
Long-term maternal
Urinary incontinence 7 (6.4%) 3 1 3 0
Faecal incontinence 7 (6.4%) 3 1 3 0
Breastfeeding complications 6 (5.5%) 3 1 2 0
Features of labour
Vaginal Breech Birth 101 (93.5%) 12 0 20 0 69
Elective caesarean 83 (76.8%) 7 1 16 0 59
Emergency caesarean 78 (72.2%) 9 1 27 0 41
Actual mode of birth 46 (42.5%) 7 1 28 0 10
Planned mode of birth 33 (30.5%) 2 1 13 0 17
Induction of labour 33 (30.5%) 1 0 28 0 4

P-primary; S-secondary; N-undesignated; C-part of composite; G-as a subject group.

Table 3 Summary of main findings and implications

Frequency of methodological assessment criteria.

Outcome Stated Defined The results show that there is substantial inconsistency in the
Primary Yes 47 Yes 65 outcomes currently being reported. Mode of birth (vaginal breech
No 61 No 43 birth, planned, and emergency CS) was the most commonly
Secondary Yes 21 Yes 26 reported outcome. However, mode of birth is measured in almost
No 29 No 24
N/a 58 N/a 58
every study as a subject group, i.e., to classify risks associated with
each of the three modes of birth for breech presentation at term;
this provided little information on the birth outcome based on
intention-to-treat. Neonatal outcomes were more commonly
Table 4 reported than maternal ones: APGAR score, perinatal mortality,
Frequency of different definitions for perinatal mortality. and admission to NICU; maternal mortality, PPH, and PPH requir-
Definition of outcome Frequency
ing transfusion were reported most frequently in each of the cate-
gories respectively.
Undefined 35
Our results partially correspond with outcomes identified as
Within 28 days 11
Intrapartum or within 7 days 7 ‘critical’ or ‘important’ in the recent NICE evidence review for
Intrapartum or within 28 days 4 breech presenting in labour, informing the guideline for Intra-
Intrapartum or within 30 days 3 partum care for women with existing medical conditions or obstet-
Within 7 days 3
ric complications and their babies [11]. Concerning maternal
Before discharge 2
Intrapartum or before discharge 1
outcomes, the evidence review identifies maternal mortality and
Intrapartum or within 27 days (early 0–6/late 7–27) 1 major morbidities as critical, defined as obstetric anal sphincter
Intrapartum stillbirth and undefined neonatal mortality 1 injury (OASI), PPH and systemic infection. In our review, these
were also the most common reported maternal outcomes. How-
ever, none of them was reported in over 25% of studies, and the
fects of a possibly traumatic birth experience and feeling isolated heterogeneity with which they were measured would preclude
during pregnancy. These concerns may also be important out- meaningful comparisons. For example, studies reporting genital
comes to measure. tract trauma seldom specifically reported rates of OASI, and the
threshold for reporting PPH as an outcome differed considerably
between studies. If a consensus agreement is reached that these,
and similar major morbidities described for babies, are indeed crit-
ical to enable meaningful comparisons, agreement will also need to
Discussion be reached on their definition and measurement.
The results demonstrated a lack of consensus in the measure-
In designing a robust clinical trial, outcomes must be chosen ment period for perinatal mortality, also identified as ‘critical’ by
carefully, reflecting clinical importance for service providers and NICE. Some studies measured deaths in the entire perinatal period
meaningful endpoints for service users [4,6]. This systematic liter- (antepartum and intrapartum stillbirths and neonatal deaths) [12],
ature review has identified a comprehensive list of outcomes others only included the intrapartum and early neonatal period
reported in current comparative studies of breech birth at term (within 7 days of life) [13,14], while others still included the intra-
and assessed their variation and frequency; the first step of devel- partum and neonatal deaths within the first 28 days of life [15].
oping a Breech-COS. Often there was no clear definition of what time period was con-

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S. Walker, T. Dasgupta, A. Halliday et al.
sidered for neonatal death [16,17]. This heterogeneity in reporting
increases the likelihood of measurement inconsistency, inability to
compare evidence, and can lead to research waste.
Although not identified by NICE, APGAR score at 5 min is likely
to be of clinical importance to service providers, as it is reflective of
long-term cognitive outcomes for the baby such as reduced IQ [18]
and scores less than 7 have been associated with neurological dis-
ability and low cognitive function in early adulthood [19]. Measur-
ing this outcome would be crucial in early detection of at-risk
children and the consequent development of early intervention
programs [20].
The third commonly reported neonatal outcome, admission to
NICU, is likely to have economic implications, increasing hospital
and health service costs [21]. The importance of including this out-
come is consistent with the findings of the PPI group meeting,
where premature cord-clamping and admission to NICU were
identified as a source of concern and distress for new mothers.
The findings of this review are also concomitant with recent
outcome sets developed in evaluating maternity care, where a
3-round Delphi study with key global stakeholders identified
maternal death, mode of birth including use of instruments/
manoeuvres, neonatal death, NICU admission, and PPH as the most
important outcomes [22].
The results also showed that long-term maternal outcomes
were very rarely reported (less than7%), particularly positive
health focused, or salutogenic, outcomes. Where they were
reported, most were measured by healthcare workers rather than
patient-centred and self-reported. Participants in the PPI group
expressed that their birth experience had long-term emotional
effects, both positive and negative, and they would like more
acknowledgement of these effects in research design. Long-term
health outcomes and outcomes for subsequent pregnancies were
also deemed important to service users, although these were less
likely to be reported in current studies.
Less than 30% of the included studies clearly defined and stated
the primary and secondary (where relevant) objectives. Further-
more, there was an inconsistency in outcome definition and
nomenclature. PPI group members stressed the importance of
availability of robust risk outcome statistics and inclusion of out-
comes related to features of labour such as manoeuvres used and
long-term effects on women, particularly mental health related
effects.
Strengths and limitations
Breech birth at term is an under-researched topic within mater-
nal and child health, with no clinical trial published since 2000.
Therefore, evidence synthesis depends heavily on the results of
non-randomised observational cohort studies. To the best of our
knowledge, there exists no published COS to investigate outcomes
of breech birth at term [7]. This systematic review, and Breech-COS
once developed, will bridge this gap in the literature, enable
improved synthesis of evidence, and alleviate some of the method-
ological issues discussed above in comparing effectiveness studies
on breech birth at term. This study design benefits from its inclu-
sion and involvement of PPI members, ensuring that research find-
ings are relevant and meaningful to service users.
A strength of this review includes the comprehensive search
criterion that yielded a wide-ranging list of outcomes. However,
not all of these might be of clinical importance, and many might
not be feasible to collect in a low-resource setting. Effectively com-
bining, prioritising, and comparing these results in the future Del-
phi study, can help prevent unnecessary confusion and wasted
resources [4]. The adapted methodological assessment design for
this review allowed appraisal of outcomes but does not speak of
limitations and inherent bias present in each of the included stud-
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European Journal of Obstetrics & Gynecology and Reproductive Biology 263 (2021) 117–126
ies. Therefore, there is a risk of reporting bias present. In particular
and most relevant to our work: outcome reporting bias which can
be defined as selective reporting of some outcomes but not others,
due to the influence of the results or statistical insignificance,
which may compromise the validity of results [5,6].
Conclusion
This systematic review provides a comprehensive assessment of
outcomes currently reported in effectiveness studies of breech
birth at term. Data was extracted from 108 studies which yielded
211 outcomes in total. Heterogeneity in reported outcomes and
lack of consensus in definition and specifics on measurement indi-
cates a need to develop a COS in this field, in order to inform future
effectiveness studies and the development of a trial protocol cur-
rently undergoing feasibility testing.
Author’s contribution
SW is the Chief Investigator; she conceived the study, led the
proposal and protocol development. SW and TD wrote this manu-
script. SW, TD, AH, and AR contributed to screening, data extrac-
tion and analysis. Professor Jane Sandall, Professor Andrew
Shennan, Dr Catey Bunce and Phoebe Roberts (service user) con-
tributed to study design and development of the proposal. All
authors read and approved the final manuscript.
Funding
This study is funded by a National Institute of Health Research
(NIHR300582) Advanced Fellowship and supported by the National
Institute for Health Research (NIHR) Applied Research Collabora-
tion South London (NIHR ARC South London) at King’s College
Hospital NHS Foundation Trust. The views expressed are those of
the author(s) and not necessarily those of the NIHR or the Depart-
ment of Health and Social Care. The COS Delphi was registered
with the King’s College London Research Ethics Office (MRA-
18/19–13879). Study design and development, as well as data col-
lection, management, analysis, interpretation, and writing of the
report was conducted independent of the study sponsor and
funder.
Declaration of Competing Interest
Shawn Walker, the lead author, is a co-Director of the Breech
Birth Network, a community interest not-for-profit company.
Appendix A. Supplementary data
Supplementary data to this article can be found online at
https://doi.org/10.1016/j.ejogrb.2021.06.021.
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