CD004660
CD004660
CD004660
Library
Cochrane Database of Systematic Reviews
www.cochranelibrary.com
TABLE OF CONTENTS
ABSTRACT..................................................................................................................................................................................................... 1
PLAIN LANGUAGE SUMMARY....................................................................................................................................................................... 2
BACKGROUND.............................................................................................................................................................................................. 3
OBJECTIVES.................................................................................................................................................................................................. 5
METHODS..................................................................................................................................................................................................... 5
RESULTS........................................................................................................................................................................................................ 8
DISCUSSION.................................................................................................................................................................................................. 8
AUTHORS' CONCLUSIONS........................................................................................................................................................................... 9
ACKNOWLEDGEMENTS................................................................................................................................................................................ 9
REFERENCES................................................................................................................................................................................................ 10
CHARACTERISTICS OF STUDIES.................................................................................................................................................................. 13
APPENDICES................................................................................................................................................................................................. 14
WHAT'S NEW................................................................................................................................................................................................. 14
HISTORY........................................................................................................................................................................................................ 14
CONTRIBUTIONS OF AUTHORS................................................................................................................................................................... 14
DECLARATIONS OF INTEREST..................................................................................................................................................................... 14
SOURCES OF SUPPORT............................................................................................................................................................................... 14
DIFFERENCES BETWEEN PROTOCOL AND REVIEW.................................................................................................................................... 15
INDEX TERMS............................................................................................................................................................................................... 15
[Intervention Review]
Tina Lavender1, G Justus Hofmeyr2, James P Neilson3, Carol Kingdon4, Gillian ML Gyte5
1School of Nursing, Midwifery and Social Work, The University of Manchester, Manchester, UK. 2Department of Obstetrics and
Gynaecology, East London Hospital Complex, University of the Witwatersrand, University of Fort Hare, Eastern Cape Department of
Health, East London, South Africa. 3Department of Women's and Children's Health, The University of Liverpool, Liverpool, UK. 4School
of Health, University of Central Lancashire, Preston, UK. 5Cochrane Pregnancy and Childbirth Group, Department of Women's and
Children's Health, The University of Liverpool, Liverpool, UK
Contact: Tina Lavender, School of Nursing, Midwifery and Social Work, The University of Manchester, Oxford Road, Manchester, M13 9PL,
UK. [email protected].
Citation: Lavender T, Hofmeyr GJ, Neilson JP, Kingdon C, Gyte GML. Caesarean section for non-medical reasons at term. Cochrane
Database of Systematic Reviews 2012, Issue 3. Art. No.: CD004660. DOI: 10.1002/14651858.CD004660.pub3.
Copyright © 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
ABSTRACT
Background
Caesarean section rates are progressively rising in many parts of the world. One suggested reason is increasing requests by women for
caesarean section in the absence of clear medical indications, such as placenta praevia, HIV infection, contracted pelvis and, arguably,
breech presentation or previous caesarean section. The reported benefits of planned caesarean section include greater safety for the
baby, less pelvic floor trauma for the mother, avoidance of labour pain and convenience. The potential disadvantages, from observational
studies, include increased risk of major morbidity or mortality for the mother, adverse psychological sequelae, and problems in subsequent
pregnancies, including uterine scar rupture and a greater risk of stillbirth and neonatal morbidity. The differences in neonatal physiology
following vaginal and caesarean births are thought to have implications for the infant, with caesarean section potentially increasing the
risk of compromised health in both the short and the long term. An unbiased assessment of advantages and disadvantages would assist
discussion of what has become a contentious issue in modern obstetrics.
Objectives
To assess, from randomised trials, the effects on perinatal and maternal morbidity and mortality, and on maternal psychological morbidity,
of planned caesarean delivery versus planned vaginal birth in women with no clear clinical indication for caesarean section.
Search methods
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 January 2012) and reference lists of relevant studies.
Selection criteria
All comparisons of intention to perform caesarean section and intention for women to give birth vaginally; random allocation to treatment
and control groups; adequate allocation concealment; women at term with single fetuses with cephalic presentations and no clear medical
indication for caesarean section.
Main results
There were no included trials.
Authors' conclusions
There is no evidence from randomised controlled trials, upon which to base any practice recommendations regarding planned caesarean
section for non-medical reasons at term. In the absence of trial data, there is an urgent need for a systematic review of observational studies
and a synthesis of qualitative data to better assess the short- and long-term effects of caesarean section and vaginal birth.
Childbirth is a profound and powerful human experience. Women often describe feelings of empowerment, elation and achievement,
although other women's experiences include trauma, fear, pain, and loss of control. The way women give birth, either vaginally or by
caesarean section, is likely to impact on their feelings. In recent years, caesareans have become safer due to improved anaesthesia and
improved surgical techniques, along with the routine use of drugs at surgery to combat the increased risk of infection and blood clots
in the mother. However, caesarean section remains a surgical procedure accompanied by abdominal and uterine incisions, scarring and
adhesions. There is also evidence of an increased chance of problems in subsequent pregnancies for both women and babies.
This review found no trials to help assess the risks and benefits of caesarean section when undertaken without a conventional medical
indication. The authors strongly recommend the use of alternative research methods to gather data on the outcomes associated with
different ways of giving birth.
BACKGROUND The extent to which women's request for caesarean section for
non-medical reasons has contributed to these rates, and why, is
Description of the condition a contentious issue (Goer 2001; Karlstrom 2011; Kingdon 2009;
Lowdon 2002; McAleese 2000; Paterson-Brown 1998; Sultan 1996).
Childbirth is a profound and powerful human experience. Women's
Existing evidence from both retrospective and prospective studies
accounts of birth often describe feelings of empowerment, elation
is limited, utilising different definitions of 'maternal request',
and achievement, particularly following vaginal birth without
and reporting rates of between 1% and 48% in public sector
medical interventions (Gaskin 2003); whereas other women
healthcare systems, and 60% in the private sector (Declerq 2002;
associate childbirth with trauma, loss of control, fear, pain and
Thomas 2001). There is insufficient understanding as to why
anxiety. It is possible that the experience of giving birth may
women may request a caesarean section in the absence of a
contribute to a woman's ability to adapt to parenthood, although
medical reason. Systematic literature reviews have highlighted
there is only indirect evidence of this. Women giving birth in a
specific methodological and conceptual issues with existing studies
supportive environment have been shown to have greater self-
(Gamble 2000; McCourt 2007) as well as identifying personal and
esteem, confidence in themselves as mothers, more positive child-
cultural reasons for maternal request (Gamble 2007; Kingdon
rearing practices and less anxiety and depression after birth
2006). Moreover, a systematic review and meta-analysis of 38
(Wolman 1993).
observational studies reports a higher preference for caesarean
Description of the intervention section in women with a previous caesarean section versus women
without a previous caesarean section (29.4%; 95% confidence
The term 'caesarean section' refers to the operation of delivering interval (CI) 24.4 to 34.8 versus 10.1%; 95% CI 7.5 to 13.1
a baby through incisions made in the mother's abdominal wall respectively) (Mazzoni 2011). Women's previous birth experience,
and uterus. Performed for certain medical indications such as fear of vaginal birth, need for choice and control, coupled with
placenta praevia (placenta lying over the opening of the cervix) or the cultural acceptability of caesarean section may all influence
transverse lie (the baby lying across the uterus), caesarean section women's decision-making surrounding ways of giving birth. Whilst
can be a life-saving operation (Neilson 2003). A caesarean section it is likely that the role of the caregiver in data generation,
is medically indicated when a significant risk of adverse outcome timing of data collection, women's post-hoc rationalisation and
for mother or baby is present if the operation is not performed at recall bias, have led to the over-reporting of maternal request for
a given time (Penna 2003). However, the use of caesarean section caesarean section, nonetheless, a percentage of women are now
for more vague medical indications (failure to progress, presumed undergoing caesarean section for non-medical reasons. Informed
fetal compromise) and non-medical reasons (for example, maternal decision-making for both clinicians and women is dependent on
request) is increasing in many resource-rich health services. Non- accurate information about the consequences of caesarean section
medically indicated caesarean sections may be performed for compared with vaginal birth.
reasons other than the risk of adverse outcome if the person(s)
assessing risk feel it is outweighed by the physical or psychological In countries where the CSR is rising, the incidence of vaginal
benefits. It has been suggested, for example, that a proportion of birth is, as expected, in decline. Intervention in the physiological
women, who request caesarean section for no apparent medical processes of 'normal' birth varies according to birth setting. In
reason, may actually have been influenced by previous or current high intervention birth settings where the use of artificial oxytocin,
psychological trauma (Ryding 1993) such as sexual abuse or a electronic fetal monitoring, epidural analgesia, artificially ruptured
previous traumatic birth. These may legitimately be regarded as membranes, and instrumental deliveries are common, the extent
clinical indications. to which adverse outcomes attributed to vaginal birth may also be
associated with current obstetric management is an issue. The use
In the UK, caesarean section accounted for 2% of all births in of forceps may be particularly relevant to the debate on the possible
1953, 18% in 1997 (Macfarlane 2000) and 21% in 2001 (Thomas maternal benefits of caesarean delivery increasingly being cited as
2001). In 2010, the caesarean section rate (CSR) for England was including the protection of the pelvic floor to avoid perineal pain,
24.8% (ICHSC 2010). Statistics for Australia and the United States dyspareunia, uterovaginal prolapse and incontinence of urine,
of America show almost one in every three pregnant women have flatus and/or faeces (Farrell 2001; Rortveit 2003; Sultan 1993;
a caesarean birth (Laws 2007; MacDorman 2008). Whilst there Sultan 1994; Sultan 1996; Sultan 1997). Conversely, a large, 12-year,
has been a world-wide trend towards increasing CSRs, the rates postpartum cohort study has reported caesarean section was not
vary considerably within and between countries. In Norway, wide protective for urinary incontinence unless all the women’s births
variations in CSRs (between 6% and 20%) have been reported were exclusively by caesarean section. Moreover, even after women
between obstetric departments (Bergen 2002). In the United having exclusively caesarean sections, the prevalence of urinary
States of America, figures from alternative birth settings show incontinence was high at 40% (MacArthur 2011).
considerably lower CSRs (1.5% - Gaskin 2003) than the national
average (24.4% - Martin 2002). Furthermore, marked differences Other possible benefits of elective caesarean section discussed
are reported in rates from different healthcare sectors. During a in both the professional and lay press include the convenience
two-year period in an urban area of India, total CSRs in the public, of scheduling the time and date of birth (Kirby 1999; Wagner
charitable and private sectors were 20%, 38% and 47% respectively 2000). The extent to which convenience is cited as a maternal
(Sreevidya 2003). The authors of this study speculate that physician benefit may be confounded by the convenience for caregivers.
convenience, preferences and financial incentives (for individuals The opportunity to schedule caesarean sections enables caregivers
and healthcare organisations) contribute to high CSRs in the private to plan staffing levels accordingly, performing the caesarean
sector, and suggest that such factors may be important in other sections within daylight hours, and possibly reduce the incidence
healthcare settings. of litigation associated with vaginal birth or emergency caesareans
(Birchard 1999). Avoidance of pain during labour has also been
cited as a potential maternal benefit of elective caesarean delivery more women reported that it was less of a problem in the
(Turnbull 1999); as has the avoidance of emergency caesarean planned caesarean delivery group. At three months there were
sections during labour, which has been associated with increases no differences between groups in breastfeeding; infant health;
in morbidity and mortality (Lilford 1990; Paterson-Brown 1998). ease of caring for infant and adjusting to being a new mother;
Precise assessments of the mortality risks associated with elective sexual relations; pain; depression; and views regarding childbirth
caesarean section for non-medical reasons are problematic due to experience. The trial reported a significant reduction in adverse
multiple definitions of 'elective', and a lack of up-to-date data which perinatal outcomes without an increased risk of immediate
distinguishes between outcomes from scheduled or emergency maternal morbidity with planned caesarean section compared
caesarean sections. Nevertheless, Hall and Bewley (Hall 1999) have with planned vaginal birth. The two-year follow up of the same
calculated the case-fatality rate for elective caesarean section in the trial (Hannah 2004) showed no differences between groups in
UK during 1994 to 1996 and estimate it to be almost three times as breastfeeding; relationship with child or partner; pain; subsequent
great as that for vaginal births. pregnancy; incontinence; depression; urinary, menstrual or sexual
problems; fatigue; or distressing memories of the birth experience.
The benefit-risk calculus associated with surgery has evolved, Planned caesarean section was associated with a higher risk of
as techniques for surgery, anaesthesia, infection control, and constipation. There was no difference identified between planned
blood banking have improved (Minkoff 2003). Nonetheless, there caesarean section and planned vaginal birth in risk of death or
is evidence to suggest increased maternal risks associated with neurodevelopmental delay in children at two years of age (Whyte
the surgery, including anaesthetic risks, surgical complications, 2004). This finding was surprising, given the reduction in the risk
increased blood loss, need for transfusion, and pulmonary of perinatal or neonatal death, or serious neonatal morbidity,
embolism (Kelleher 1994). There may also be restricted activities with a policy of planned caesarean birth found at three months.
of daily living (Chippington 2004), breastfeeding difficulties The applicability of these findings for cephalic presentation is
(Francome 1993) and increased maternal problems related to debatable.
the uterine scar in subsequent pregnancies (Hemminki 1996). A
retrospective cohort study of 308,755 Canadian women who had Maternal and neonatal physical health outcomes must also
experienced a previous caesarean section found trial of labour is be considered alongside psychosocial influences and the wider
associated with increased risk of uterine rupture (0.65% in the cultural context. For example, the trend towards smaller families
trial of labour group compared with 0.25% in the non-trial of may be relevant when considering the risks of caesarean section
labour group), but elective caesarean section may increase the for subsequent pregnancies. The increasingly cited risks of vaginal
risk of maternal death (1.6 per 100,000 in the trial of labour group birth such as placental abruption, cord prolapse, undiagnosed fetal
compared with 5.6 per 100,000 in the elective caesarean section hypoxaemia and shoulder dystocia (Paterson-Brown 1997) must be
group (Wen 2004). Furthermore new, unexpected long-term risks of considered in the context of the medical model within technology-
caesarean section continue to be reported; these include abnormal dependent cultures where intervention in the natural processes
placentation (Serena 2005), ectopic pregnancy, haemorrhage of reproduction is common. For many healthcare systems, the
and hysterectomy following uterine evacuation, latex allergy, economic costs associated with different modes of delivery are as
implantation endometriosis, adenomyosis and increased hospital pertinent as the social costs. A recent economic model, developed
readmission (Bewley 2002). Caesarean section has also been to determine the cost consequence of planned caesarean section
associated with emotional difficulties (Clement 2001) including in the absence of medical indication to the NHS, estimated it
postpartum depression and negative feelings about the experience to range from £10.9 to £14.8 million per annum. The mean cost
of childbirth, but not specifically among women undergoing saving of switching from a planned caesarean section to a planned
caesarean delivery by choice (Minkoff 2003). Suggested increased vaginal birth was £1257 per birth (NCCWCH 2004). However, in the
risks for the baby of delivery by caesarean section include, USA it would appear the costs of increased intervention in vaginal
increased admission to neonatal units/separation of the mother deliveries, the addition of oxytocin specifically, can nullify any cost
and neonate (Treffers 1993), iatrogenic prematurity (Wagner 2000), differences between delivery mode. If epidural anaesthesia is also
laceration (Smith 1997), increased neonatal respiratory problems used, total costs exceeded the cost of elective caesarean delivery by
(Madar 1999), increased special educational needs in later life almost 10% in one study (Bost 2003).
linked to the timing of the caesarean section (Kapellou 2011;
MacKay 2010) and stillbirth in the next pregnancy (Smith 2003). This review is one of a series of Cochrane reviews on planned
A recent literature review suggests that vaginal births involve caesarean section; other reviews focus on elective caesarean
important physiological changes that are absent or modified in section for medical indications ('Planned caesarean section for
babies born by caesarean section (Hyde 2011). Authors suggest term breech delivery' (Hofmeyr 2003), 'Planned elective repeat
that vaginal birth is an important life programming event for the caesarean section versus planned vaginal birth for women with a
infant, and that the differences in physiology that arise between previous caesarean birth' (Dodd 2004), 'Planned caesarean section
vaginal and caesarean births have implications for the infant, with for multiple pregnancy' (Dodd 2002).
caesarean section increasing the risk of compromised health in
both the short and the long term (Hyde 2011). Why it is important to do this review
Caesarean section for non-medical reasons is a multifaceted
In a large multi-centre randomised controlled trial of planned
complex issue, the implications of which for childbearing women,
caesarean section versus planned vaginal birth for breech
healthcare professionals and society are unknown. For women,
presentation, at three months postnatally, women in the planned
requesting a caesarean section for non-medical reasons is an
caesarean delivery group were less likely to report urinary
emotive and very personal decision. For clinicians, performing
incontinence (Hannah 2002). There was no statistically significant
a caesarean section for non-medical reasons is a professional
difference regarding incontinence of flatus between groups, but
decision, the ethics of which are being debated without sufficient
Caesarean section for non-medical reasons at term (Review) 4
Copyright © 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Cochrane Trusted evidence.
Informed decisions.
Library Better health. Cochrane Database of Systematic Reviews
evidence of the risks, as well as the benefits. The review aims 11.postpartum pyrexia (infection, wound, bladder, perineum,
to assist women and clinicians to make informed evidence-based genital tract, chest, haematoma: wound, perineum);
decisions about the way women give birth. 12.other operative postpartum interventions (evacuation of
retained products of conception, evacuation of haematoma,
OBJECTIVES wound/episiotomy repair);
To assess, from randomised trials, the effects on perinatal and 13.antibiotic use;
maternal morbidity and mortality, and on maternal psychological 14.antithrombotic prophylaxis;
morbidity, of planned caesarean delivery versus planned vaginal 15.experience of childbirth.
birth where there is no clear clinical indication for a caesarean
section. Long-term maternal outcomes
bias; missing data insufficient to materially influence conclusions; will consult a third person. We will enter data into Review Manager
data available for analysis according to original allocation, software (RevMan 2011) and check for accuracy.
irrespective of protocol violations; data available in format suitable
for analysis. When information regarding any of the above is unclear, we will
attempt to contact authors of the original reports to provide further
Search methods for identification of studies details.
Electronic searches Assessment of risk of bias in included studies
We searched the Cochrane Pregnancy and Childbirth Group’s Trials Two review authors will independently assess risk of bias for each
Register by contacting the Trials Search Co-ordinator (31 January study using the criteria outlined in the Cochrane Handbook for
2012). Systematic Reviews of Interventions (Higgins 2011). We will resolve
any disagreement by discussion or by involving a third assessor.
The Cochrane Pregnancy and Childbirth Group’s Trials Register is
maintained by the Trials Search Co-ordinator and contains trials (1) Random sequence generation (checking for possible
identified from: selection bias)
1. quarterly searches of the Cochrane Central Register of We will describe for each included study the method used to
Controlled Trials (CENTRAL); generate the allocation sequence in sufficient detail to allow an
2. weekly searches of MEDLINE; assessment of whether it should produce comparable groups.
3. weekly searches of EMBASE; We will assess the method as:
4. handsearches of 30 journals and the proceedings of major
conferences; • low risk of bias (any truly random process, e.g. random number
5. weekly current awareness alerts for a further 44 journals plus table; computer random number generator);
monthly BioMed Central email alerts. • high risk of bias (any non-random process, e.g. odd or even date
of birth; hospital or clinic record number);
Details of the search strategies for CENTRAL, MEDLINE and EMBASE, • unclear risk of bias.
the list of handsearched journals and conference proceedings, and
the list of journals reviewed via the current awareness service can (2) Allocation concealment (checking for possible selection bias)
be found in the ‘Specialized Register’ section within the editorial
information about the Cochrane Pregnancy and Childbirth Group. We will describe for each included study the method used to
conceal allocation to interventions prior to assignment and will
Trials identified through the searching activities described above assess whether intervention allocation could have been foreseen in
are each assigned to a review topic (or topics). The Trials Search Co- advance of, or during recruitment, or changed after assignment.
ordinator searches the register for each review using the topic list
rather than keywords. We will assess the methods as:
Searching other resources • low risk of bias (e.g. telephone or central randomisation;
consecutively numbered sealed opaque envelopes);
We searched for further studies in the reference lists. We did not • high risk of bias (open random allocation; unsealed or non-
apply any language restrictions. opaque envelopes, alternation; date of birth);
For details of searching carried out for the initial version of the • unclear risk of bias.
review, please see Appendix 1.
(3.1) Blinding of participants and personnel (checking for
Data collection and analysis possible performance bias)
It is not possible to blind either participants or personnel in
The following methodology would have been applied had we
these studies. We will consider the possible impact of this when
identified any studies, and it will be used if studies are identified in
interpreting the data for relevant outcomes.
future updates.
(3.2) Blinding of outcome assessment (checking for possible
Selection of studies
detection bias)
Three review authors (Tina Lavender, Carol Kingdon and Gill Gyte)
It will be possible to blind outcome assessors for some outcomes
independently assessed for inclusion all the potential studies
only. Where blinding is not possible, we will consider the possible
we identified as a result of the search strategy. There was
impact of this when interpreting the data for relevant outcomes.
agreement but had there been any disagreement this would have
been resolved through discussion or, if required, we would have (4) Incomplete outcome data (checking for possible attrition
consulted our remaining review authors. bias due to the amount, nature and handling of incomplete
outcome data)
Data extraction and management
We will describe for each included study, and for each outcome or
We designed a form to extract data. In future, for eligible studies, at
class of outcomes, the completeness of data including attrition and
least two review authors will extract the data using the agreed form.
exclusions from the analysis. We will state whether attrition and
We will resolve discrepancies through discussion or, if required, we
exclusions were reported and the numbers included in the analysis
at each stage (compared with the total randomised participants), Continuous data
reasons for attrition or exclusion where reported, and whether
For continuous data, we will use the mean difference if outcomes
missing data were balanced across groups or were related to
are measured in the same way between trials. We will use the
outcomes. Where sufficient information is reported, or can be
standardised mean difference to combine trials that measure the
supplied by the trial authors, we will re-include missing data in the
same outcome, but use different methods.
analyses which we undertake.
Unit of analysis issues
We will assess methods as:
We do not anticipate any cluster- or cross-over trials as we believe
• low risk of bias (e.g. 20% or less missing outcome data; missing these methodologies are unsuitable for our review question.
outcome data balanced across groups);
• high risk of bias (e.g. greater than 20% missing data; missing Dealing with missing data
data imbalanced across groups; ‘as treated’ analysis done For included studies, we will note levels of attrition. We will explore
with substantial departure of intervention received from that the impact of including studies with high levels of missing data
assigned at randomisation); in the overall assessment of treatment effect by using sensitivity
• unclear risk of bias. analysis.
(5) Selective reporting (checking for reporting bias) For all outcomes, we will carry out analyses, as far as possible,
We will describe for each included study how we investigated the on an intention-to-treat basis, i.e. we will attempt to include all
possibility of selective outcome reporting bias and what we found. participants randomised to each group in the analyses, and all
participants will be analysed in the group to which they were
We will assess the methods as: allocated, regardless of whether or not they received the allocated
intervention. The denominator for each outcome in each trial
• low risk of bias (where it is clear that all of the study’s pre- will be the number randomised minus any participants whose
specified outcomes and all expected outcomes of interest to the outcomes are known to be missing.
review have been reported);
• high risk of bias (where not all the study’s pre-specified Assessment of heterogeneity
outcomes have been reported; one or more reported primary We will assess statistical heterogeneity in each meta-analysis using
outcomes were not pre-specified; outcomes of interest are the T2, I2 and Chi2 statistics. We will regard heterogeneity as
reported incompletely and so cannot be used; study fails to substantial if I2 is greater than 30% and either T2 is greater than
include results of a key outcome that would have been expected zero, or there is a low P value (less than 0.10) in the Chi2 test for
to have been reported); heterogeneity.
• unclear risk of bias.
Assessment of reporting biases
(6) Other bias (checking for bias due to problems not covered by
If there are 10 or more studies in the meta-analysis, we will
(1) to (5) above)
investigate reporting biases (such as publication bias) using funnel
We will describe for each included study any important concerns plots. We will assess funnel plot asymmetry visually, and use formal
we have about other possible sources of bias. tests for funnel plot asymmetry. For continuous outcomes, we
will use the test proposed by Egger 1997, and for dichotomous
We will assess whether each study was free of other problems that outcomes, we will use the test proposed by Harbord 2006. If
could put it at risk of bias: asymmetry is detected in any of these tests, or is suggested
by a visual assessment, we will perform exploratory analyses to
• low risk of other bias;
investigate it.
• high risk of other bias;
• unclear whether there is risk of other bias. Data synthesis
(7) Overall risk of bias We will carry out statistical analysis using the Review Manager
software (RevMan 2011). We will use fixed-effect meta-analysis
We will make explicit judgements about whether studies are at for combining data where it is reasonable to assume that
high risk of bias, according to the criteria given in the Cochrane studies are estimating the same underlying treatment effect: i.e.
Handbook for Systematic Reviews of Interventions (Higgins 2011). where trials are examining the same intervention, and the trials’
With reference to (1) to (6) above, we will assess the likely populations and methods are judged sufficiently similar. If there
magnitude and direction of the bias and whether we consider it is clinical heterogeneity sufficient to expect that the underlying
is likely to impact on the findings. We will explore the impact treatment effects differ between trials, or if substantial statistical
of the level of bias through undertaking sensitivity analyses - see heterogeneity is detected, we will use random-effects meta-
Sensitivity analysis. analysis to produce an overall summary if an average treatment
effect across trials is considered clinically meaningful. The random-
Measures of treatment effect effects summary will be treated as the average range of possible
Dichotomous data treatment effects and we will discuss the clinical implications of
treatment effects differing between trials. If the average treatment
For dichotomous data, we will present results as summary risk ratio effect is not clinically meaningful, we will not combine trials.
with 95% confidence intervals.
If we use random-effects analyses, the results will be presented as Risk of bias in included studies
the average treatment effect with 95% confidence intervals, and the
estimates of T2 and I2. No studies met the eligibility criteria for inclusion in this review.
been raised by health professionals (Lavender 2005) and women be due to the lack of equipoise for such a trial or the highly
(Lavender 2009), in the UK. complex methodological issues which such a trial may generate
(Lavender 2005). These include the complexity of following up
AUTHORS' CONCLUSIONS women throughout their reproductive life; the difficulty of agreeing
on a single primary outcome on which to base sample-size
Implications for practice calculations; and the prohibitive cost of a trial in relation to more
There is no evidence from randomised controlled trials upon pertinent research questions. The routine collection of good quality
which to base any practice recommendations regarding planned prospective morbidity data (short and long term) may provide the
caesarean section for non-medical reasons at term. best available evidence from which women can make informed
decisions. Qualitative explorations which contextualise maternal
Implications for research and professional views and experiences would also add to the
evidence base. In the absence of trial data, there is an urgent need
Although a number of trials have assessed the efficacy of for a systematic review of observational studies and a synthesis of
planned vaginal birth versus planned caesarean section, sample qualitative data to better assess the short- and long-term outcomes
populations have included women with potential (Barrett 2004; of caesarean section and vaginal birth.
Dodd 2004; Hannah 2000) or actual pregnancy complications
(European Mode 1999). Planned caesarean section for non-medical ACKNOWLEDGEMENTS
reasons at term is more contentious because it involves a
surgical procedure where there is neither a medical problem Stephen Milan.
nor any complications. The lack of existing evidence is likely to
REFERENCES
CHARACTERISTICS OF STUDIES
European Mode 1999 Pregnant women with confirmed diagnosis of HIV-1 infection were randomly assigned to planned
caesarean section (n = 188) at 38 weeks of pregnancy or vaginal birth (n = 220).
3 of 170 infants born to women assigned caesarean section delivery were infected compared with
21 of 200 born to women assigned vaginal delivery P < 0.001.
This study was excluded as confirmed diagnosis of HIV-1 infection is a conventional indication for
caesarean section. Furthermore, it is unclear from the data how many participants had singleton
pregnancies, cephalic presentations or term babies: "for women with a previous caesarean section
twin pregnancy, breech presentation, intrauterine growth retardation or vaginal infection, e.g. ac-
tive herpes infection, the decision to randomise was at the clinicians discretion".
Pence 2002 Pregnant women between 37 and 42 weeks' gestation were randomly assigned to 1 of 3 groups:
group 1 (n = 40) were vaginally delivered, group 2 (n = 26) had caesarean section with epidural
anaesthesia, and group 3 (n = 30) had caesarean section under general anaesthesia. The primary
outcome measure was umbilical arterial PO2 which was found to be higher in group 3.
The study was excluded because of the potential for selection bias; it is unclear whether this is ac-
tually a randomised controlled trial. The demography and parity of the sample was not reported
therefore findings could not be interpreted.
APPENDICES
We also performed a manual search of the references of all retrieved articles. We sought unpublished papers and abstracts submitted to
international conferences and contacted expert informants.
WHAT'S NEW
31 January 2012 New search has been performed Search updated. Methodology updated. No new trials identified.
HISTORY
Protocol first published: Issue 1, 2004
Review first published: Issue 3, 2006
28 April 2009 New search has been performed Search updated. No new trials identified.
CONTRIBUTIONS OF AUTHORS
T Lavender, C Kingdon and G Gyte reviewed the papers. T Lavender and C Kingdon wrote the first draft of the review. G Gyte, J Neilson and
G Hofmeyr commented on review drafts. For this update, T Lavender, C Kingdon and G Gyte updated the review. The final version of the
updated review was reviewed and approved by all authors.
DECLARATIONS OF INTEREST
None known.
SOURCES OF SUPPORT
Internal sources
• University of the Witwatersrand, South Africa.
• University of Central Lancashire, UK.
• The University of Liverpool, UK.
• Liverpool Women's NHS Foundation Trust, UK.
External sources
• HRP - UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction,
Geneva, Switzerland.
• National Institute for Health Research, UK.
NIHR Programme of centrally-managed pregnancy and childbirth systematic reviews of priority to the NHS and users of theNHS:
10/4001/02
INDEX TERMS