BACKGROUND: Women with a suspected large-for-dates fetus or a fetus with suspected macrosomia (birthweight greater than 4000 g) are at risk of operative birth or caesarean section. The baby is also at increased risk of shoulder dystocia and trauma, in particular fractures and brachial plexus injury. Induction of labour may reduce these risks by decreasing the birthweight, but may also lead to longer labours and an increased risk of caesarean section.
OBJECTIVES: To assess the effects of a policy of labour induction at or shortly before term (37 to 40 weeks) for suspected fetal macrosomia on the way of giving birth and maternal or perinatal morbidity.
SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 January 2016), contacted trial authors and searched reference lists of retrieved studies.
SELECTION CRITERIA: Randomised trials of induction of labour for suspected fetal macrosomia.
DATA COLLECTION AND ANALYSIS: Review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. We contacted study authors for additional information. For key outcomes the quality of the evidence was assessed using the GRADE approach.
MAIN RESULTS: We included four trials, involving 1190 women. It was not possible to blind women and staff to the intervention, but for other 'Risk of bias' domains these studies were assessed as being at low or unclear risk of bias. Compared to expectant management, there was no clear effect of induction of labour for suspected macrosomia on the risk of caesarean section (risk ratio (RR) 0.91, 95% confidence interval (CI) 0.76 to 1.09; 1190 women; four trials, moderate-quality evidence) or instrumental delivery (RR 0.86, 95% CI 0.65 to 1.13; 1190 women; four trials, low-quality evidence). Shoulder dystocia (RR 0.60, 95% CI 0.37 to 0.98; 1190 women; four trials, moderate-quality evidence), and fracture (any) (RR 0.20, 95% CI 0.05 to 0.79; 1190 women; four studies, high-quality evidence) were reduced in the induction of labour group. There were no clear differences between groups for brachial plexus injury (two events were reported in the control group in one trial, low-quality evidence). There was no strong evidence of any difference between groups for measures of neonatal asphyxia; low five-minute infant Apgar scores (less than seven) or low arterial cord blood pH (RR 1.51, 95% CI 0.25 to 9.02; 858 infants; two trials, low-quality evidence; and, RR 1.01, 95% CI 0.46 to 2.22; 818 infants; one trial, moderate-quality evidence, respectively). Mean birthweight was lower in the induction group, but there was considerable heterogeneity between studies for this outcome (mean difference (MD) -178.03 g, 95% CI -315.26 to -40.81; 1190 infants; four studies; I2 = 89%). For outcomes assessed using GRADE, we based our downgrading decisions on high risk of bias from lack of blinding and imprecision of effect estimates.
AUTHORS' CONCLUSIONS: Induction of labour for suspected fetal macrosomia has not been shown to alter the risk of brachial plexus injury, but the power of the included studies to show a difference for such a rare event is limited. Also antenatal estimates of fetal weight are often inaccurate so many women may be worried unnecessarily, and many inductions may not be needed. Nevertheless, induction of labour for suspected fetal macrosomia results in a lower mean birthweight, and fewer birth fractures and shoulder dystocia. The observation of increased use of phototherapy in the largest trial, should also be kept in mind. Findings from trials included in the review suggest that to prevent one fracture it would be necessary to induce labour in 60 women. Since induction of labour does not appear to alter the rate of caesarean delivery or instrumental delivery, it is likely to be popular with many women. In settings where obstetricians can be reasonably confident about their scan assessment of fetal weight, the advantages and disadvantages of induction at or near term for fetuses suspected of being macrosomic should be discussed with parents. Although some parents and doctors may feel the evidence already justifies induction, others may justifiably disagree. Further trials of induction shortly before term for suspected fetal macrosomia are needed. Such trials should concentrate on refining the optimum gestation of induction, and improving the accuracy of the diagnosis of macrosomia.
BACKGROUND: Cardiotocography (CTG) records changes in the fetal heart rate and their temporal relationship to uterine contractions. The aim is to identify babies who may be short of oxygen (hypoxic) to guide additional assessments of fetal wellbeing, or determine if the baby needs to be delivered by caesarean section or instrumental vaginal birth. This is an update of a review previously published in 2013, 2006 and 2001.
OBJECTIVES: To evaluate the effectiveness and safety of continuous cardiotocography when used as a method to monitor fetal wellbeing during labour.
SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group Trials Register (30 November 2016) and reference lists of retrieved studies.
SELECTION CRITERIA: Randomised and quasi-randomised controlled trials involving a comparison of continuous cardiotocography (with and without fetal blood sampling) with no fetal monitoring, intermittent auscultation intermittent cardiotocography.
DATA COLLECTION AND ANALYSIS: Two review authors independently assessed study eligibility, quality and extracted data from included studies. Data were checked for accuracy.
MAIN RESULTS: We included 13 trials involving over 37,000 women. No new studies were included in this update.One trial (4044 women) compared continuous CTG with intermittent CTG, all other trials compared continuous CTG with intermittent auscultation. No data were found comparing no fetal monitoring with continuous CTG. Overall, methodological quality was mixed. All included studies were at high risk of performance bias, unclear or high risk of detection bias, and unclear risk of reporting bias. Only two trials were assessed at high methodological quality.Compared with intermittent auscultation, continuous cardiotocography showed no significant improvement in overall perinatal death rate (risk ratio (RR) 0.86, 95% confidence interval (CI) 0.59 to 1.23, N = 33,513, 11 trials, low quality evidence), but was associated with halving neonatal seizure rates (RR 0.50, 95% CI 0.31 to 0.80, N = 32,386, 9 trials, moderate quality evidence). There was no difference in cerebral palsy rates (RR 1.75, 95% CI 0.84 to 3.63, N = 13,252, 2 trials, low quality evidence). There was an increase in caesarean sections associated with continuous CTG (RR 1.63, 95% CI 1.29 to 2.07, N = 18,861, 11 trials, low quality evidence). Women were also more likely to have instrumental vaginal births (RR 1.15, 95% CI 1.01 to 1.33, N = 18,615, 10 trials, low quality evidence). There was no difference in the incidence of cord blood acidosis (RR 0.92, 95% CI 0.27 to 3.11, N = 2494, 2 trials, very low quality evidence) or use of any pharmacological analgesia (RR 0.98, 95% CI 0.88 to 1.09, N = 1677, 3 trials, low quality evidence).Compared with intermittent CTG, continuous CTG made no difference to caesarean section rates (RR 1.29, 95% CI 0.84 to 1.97, N = 4044, 1 trial) or instrumental births (RR 1.16, 95% CI 0.92 to 1.46, N = 4044, 1 trial). Less cord blood acidosis was observed in women who had intermittent CTG, however, this result could have been due to chance (RR 1.43, 95% CI 0.95 to 2.14, N = 4044, 1 trial).Data for low risk, high risk, preterm pregnancy and high-quality trials subgroups were consistent with overall results. Access to fetal blood sampling did not appear to influence differences in neonatal seizures or other outcomes.Evidence was assessed using GRADE. Most outcomes were graded as low quality evidence (rates of perinatal death, cerebral palsy, caesarean section, instrumental vaginal births, and any pharmacological analgesia), and downgraded for limitations in design, inconsistency and imprecision of results. The remaining outcomes were downgraded to moderate quality (neonatal seizures) and very low quality (cord blood acidosis) due to similar concerns over limitations in design, inconsistency and imprecision.
AUTHORS' CONCLUSIONS: CTG during labour is associated with reduced rates of neonatal seizures, but no clear differences in cerebral palsy, infant mortality or other standard measures of neonatal wellbeing. However, continuous CTG was associated with an increase in caesarean sections and instrumental vaginal births. The challenge is how best to convey these results to women to enable them to make an informed decision without compromising the normality of labour.The question remains as to whether future randomised trials should measure efficacy (the intrinsic value of continuous CTG in trying to prevent adverse neonatal outcomes under optimal clinical conditions) or effectiveness (the effect of this technique in routine clinical practice).Along with the need for further investigations into long-term effects of operative births for women and babies, much remains to be learned about the causation and possible links between antenatal or intrapartum events, neonatal seizures and long-term neurodevelopmental outcomes, whilst considering changes in clinical practice over the intervening years (one-to-one-support during labour, caesarean section rates). The large number of babies randomised to the trials in this review have now reached adulthood and could potentially provide a unique opportunity to clarify if a reduction in neonatal seizures is something inconsequential that should not greatly influence women's and clinicians' choices, or if seizure reduction leads to long-term benefits for babies. Defining meaningful neurological and behavioural outcomes that could be measured in large cohorts of young adults poses huge challenges. However, it is important to collect data from these women and babies while medical records still exist, where possible describe women's mobility and positions during labour and birth, and clarify if these might impact on outcomes. Research should also address the possible contribution of the supine position to adverse outcomes for babies, and assess whether the use of mobility and positions can further reduce the low incidence of neonatal seizures and improve psychological outcomes for women.
BACKGROUND: Historically, women have generally been attended and supported by other women during labour. However, in hospitals worldwide, continuous support during labour has often become the exception rather than the routine.
OBJECTIVES: The primary objective was to assess the effects, on women and their babies, of continuous, one-to-one intrapartum support compared with usual care, in any setting. Secondary objectives were to determine whether the effects of continuous support are influenced by:1. Routine practices and policies in the birth environment that may affect a woman's autonomy, freedom of movement and ability to cope with labour, including: policies about the presence of support people of the woman's own choosing; epidural analgesia; and continuous electronic fetal monitoring.2. The provider's relationship to the woman and to the facility: staff member of the facility (and thus has additional loyalties or responsibilities); not a staff member and not part of the woman's social network (present solely for the purpose of providing continuous support, e.g. a doula); or a person chosen by the woman from family members and friends;3. Timing of onset (early or later in labour);4. Model of support (support provided only around the time of childbirth or extended to include support during the antenatal and postpartum periods);5. Country income level (high-income compared to low- and middle-income).
SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 October 2016), ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (1 June 2017) and reference lists of retrieved studies.
SELECTION CRITERIA: All published and unpublished randomised controlled trials, cluster-randomised trials comparing continuous support during labour with usual care. Quasi-randomised and cross-over designs were not eligible for inclusion.
DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. We sought additional information from the trial authors. The quality of the evidence was assessed using the GRADE approach.
MAIN RESULTS: We included a total of 27 trials, and 26 trials involving 15,858 women provided usable outcome data for analysis. These trials were conducted in 17 different countries: 13 trials were conducted in high-income settings; 13 trials in middle-income settings; and no studies in low-income settings. Women allocated to continuous support were more likely to have a spontaneous vaginal birth (average RR 1.08, 95% confidence interval (CI) 1.04 to 1.12; 21 trials, 14,369 women; low-quality evidence) and less likely to report negative ratings of or feelings about their childbirth experience (average RR 0.69, 95% CI 0.59 to 0.79; 11 trials, 11,133 women; low-quality evidence) and to use any intrapartum analgesia (average RR 0.90, 95% CI 0.84 to 0.96; 15 trials, 12,433 women). In addition, their labours were shorter (MD -0.69 hours, 95% CI -1.04 to -0.34; 13 trials, 5429 women; low-quality evidence), they were less likely to have a caesarean birth (average RR 0.75, 95% CI 0.64 to 0.88; 24 trials, 15,347 women; low-quality evidence) or instrumental vaginal birth (RR 0.90, 95% CI 0.85 to 0.96; 19 trials, 14,118 women), regional analgesia (average RR 0.93, 95% CI 0.88 to 0.99; 9 trials, 11,444 women), or a baby with a low five-minute Apgar score (RR 0.62, 95% CI 0.46 to 0.85; 14 trials, 12,615 women). Data from two trials for postpartum depression were not combined due to differences in women, hospitals and care providers included; both trials found fewer women developed depressive symptomatology if they had been supported in birth, although this may have been a chance result in one of the studies (low-quality evidence). There was no apparent impact on other intrapartum interventions, maternal or neonatal complications, such as admission to special care nursery (average RR 0.97, 95% CI 0.76 to 1.25; 7 trials, 8897 women; low-quality evidence), and exclusive or any breastfeeding at any time point (average RR 1.05, 95% CI 0.96 to 1.16; 4 trials, 5584 women; low-quality evidence).Subgroup analyses suggested that continuous support was most effective at reducing caesarean birth, when the provider was present in a doula role, and in settings in which epidural analgesia was not routinely available. Continuous labour support in settings where women were not permitted to have companions of their choosing with them in labour, was associated with greater likelihood of spontaneous vaginal birth and lower likelihood of a caesarean birth. Subgroup analysis of trials conducted in high-income compared with trials in middle-income countries suggests that continuous labour support offers similar benefits to women and babies for most outcomes, with the exception of caesarean birth, where studies from middle-income countries showed a larger reduction in caesarean birth. No conclusions could be drawn about low-income settings, electronic fetal monitoring, the timing of onset of continuous support or model of support.Risk of bias varied in included studies: no study clearly blinded women and personnel; only one study sufficiently blinded outcome assessors. All other domains were of varying degrees of risk of bias. The quality of evidence was downgraded for lack of blinding in studies and other limitations in study designs, inconsistency, or imprecision of effect estimates.
AUTHORS' CONCLUSIONS: Continuous support during labour may improve outcomes for women and infants, including increased spontaneous vaginal birth, shorter duration of labour, and decreased caesarean birth, instrumental vaginal birth, use of any analgesia, use of regional analgesia, low five-minute Apgar score and negative feelings about childbirth experiences. We found no evidence of harms of continuous labour support. Subgroup analyses should be interpreted with caution, and considered as exploratory and hypothesis-generating, but evidence suggests continuous support with certain provider characteristics, in settings where epidural analgesia was not routinely available, in settings where women were not permitted to have companions of their choosing in labour, and in middle-income country settings, may have a favourable impact on outcomes such as caesarean birth. Future research on continuous support during labour could focus on longer-term outcomes (breastfeeding, mother-infant interactions, postpartum depression, self-esteem, difficulty mothering) and include more woman-centred outcomes in low-income settings.
BACKGROUND: External cephalic version (ECV) of the breech fetus at term (after 37 weeks) has been shown to be effective in reducing the number of breech presentations and caesarean sections, but the rates of success are relatively low. This review examines studies initiating ECV prior to term (before 37 weeks' gestation).
OBJECTIVES: To assess the effectiveness of a policy of beginning ECV before term (before 37 weeks' gestation) for breech presentation on fetal presentation at birth, method of delivery, and the rate of preterm birth, perinatal morbidity, stillbirth or neonatal mortality.
SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 March 2015) and reference lists of retrieved studies.
SELECTION CRITERIA: Randomised controlled trials (RCTs) of ECV attempted before term (37 weeks' gestation) or commenced before term, compared with a control group of women (in breech presentation) in which either no ECV attempted or ECV was attempted at term. Cluster-randomised trials were eligible for inclusion but none were identified. Quasi-RCTs or studies using a cross-over design were not eligible for inclusion.
DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked for accuracy. Studies were assessed for risk of bias and for important outcomes the overall quality of the evidence was assessed using the GRADE approach.
MAIN RESULTS: Five studies are included (2187 women). It was not possible for the intervention to be blinded, and it is not clear what impact lack of blinding would have on the outcomes reported. For other 'Risk of bias' domains studies were either at low or unclear risk of bias.One study reported on ECV that was undertaken and completed before 37 weeks' gestation compared with no ECV. No difference was found in the rate of non-cephalic presentation at birth (risk ratio (RR) 1.04, 95% confidence interval (CI) 0.64 to 1.69; participants = 102). One study reported on a policy of ECV that was initiated before term (33 weeks) and up until 40 weeks' gestation and which could be repeated up until delivery compared with no ECV. This study showed a decrease in the rate of non-cephalic presentation at birth (RR 0.59, 95% CI 0.45 to 0.77; participants = 179).Three studies reported on ECV started at between 34 to 35 weeks' gestation compared with beginning at 37 to 38 weeks' gestation. Pooled results suggested that early ECV reduced the risk of non-cephalic presentation at birth (RR 0.81, 95% CI 0.74 to 0.90; participants = 1906; studies = three; I² = 0%, evidence graded high quality), failure to achieve vaginal cephalic birth (RR 0.90, 95% CI 0.83 to 0.97; participants = 1888; studies = three; I² = 0%, evidence graded high quality), and vaginal breech delivery (RR 0.44, 95% CI 0.25 to 0.78; participants = 1888; studies = three; I² = 0%, evidence graded high quality). The difference between groups for risk of caesarean was not statistically significant (RR 0.92, 95% CI 0.85 to 1.00; participants = 1888; studies = three; I² = 0%, evidence graded high quality). There was evidence that risk of preterm labour was increased with early ECV compared with ECV after 37 weeks (6.6% in the ECV group and 4.3% for controls) (RR 1.51, 95% CI 1.03 to 2.21; participants = 1888; studies = three; I² = 0%, evidence graded high quality). There was no clear difference between groups for low infant Apgar score at five minutes or perinatal death (stillbirth plus neonatal mortality up to seven days) (evidence graded as low quality for both outcomes).
AUTHORS' CONCLUSIONS: Compared with no ECV attempt, ECV commenced before term reduces non-cephalic presentation at birth. Compared with ECV at term, beginning ECV at between 34 to 35 weeks may have some benefit in terms of decreasing the rate of non-cephalic presentation, and risk of vaginal breech birth. However, early ECV may increase risk of late preterm birth, and it is important that any future research reports infant morbidity outcomes. Results of the review suggest that there is a need for careful discussion with women about the timing of the ECV procedure so that they can make informed decisions.
BACKGROUND: Management of breech presentation is controversial, particularly in regard to manipulation of the position of the fetus by external cephalic version (ECV). ECV may reduce the number of breech presentations and caesarean sections, but there also have been reports of complications with the procedure.
OBJECTIVES: The objective of this review was to assess the effects of ECV at or near term on measures of pregnancy outcome. Methods of facilitating ECV, and ECV before term are reviewed separately.
SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Trials Register (28 February 2015) and reference lists of retrieved studies.
SELECTION CRITERIA: Randomised trials of ECV at or near term (with or without tocolysis) compared with no attempt at ECV in women with breech presentation.
DATA COLLECTION AND ANALYSIS: Two review authors assessed eligibility and trial quality, and extracted the data.
MAIN RESULTS: We included eight studies, with a total of 1308 women randomised. The pooled data from these studies show a statistically significant and clinically meaningful reduction in non-cephalic presentation at birth (average risk ratio (RR) 0.42, 95% confidence interval (CI) 0.29 to 0.61, eight trials, 1305 women); vaginal cephalic birth not achieved (average RR 0.46, 95% CI 0.33 to 0.62, seven trials, 1253 women, evidence graded very low); and caesarean section (average RR 0.57, 95% CI 0.40 to 0.82, eight trials, 1305 women, evidence graded very low) when ECV was attempted in comparison to no ECV attempted. There were no significant differences in the incidence of Apgar score ratings below seven at one minute (average RR 0.67, 95% CI 0.32 to 1.37, three trials, 168 infants) or five minutes (RR 0.63, 95% CI 0.29 to 1.36, five trials, 428 infants, evidence graded very low), low umbilical vein pH levels (RR 0.65, 95% CI 0.17 to 2.44, one trial, 52 infants, evidence graded very low), neonatal admission (RR 0.80, 95% CI 0.48 to 1.34, four trials, 368 infants, evidence graded very low), perinatal death (RR 0.39, 95% CI 0.09 to 1.64, eight trials, 1305 infants, evidence graded low), nor time from enrolment to delivery (mean difference -0.25 days, 95% CI -2.81 to 2.31, two trials, 256 women).All of the trials included in this review had design limitations, and the level of evidence was graded low or very low. No studies attempted to blind the intervention, and the process of random allocation was suboptimal in several studies. Three of the eight trials had serious design limitations, however excluding these studies in a sensitivity analysis for outcomes with substantial heterogeneity did not alter the results.
AUTHORS' CONCLUSIONS: Attempting cephalic version at term reduces the chance of non-cephalic presentation at birth, vaginal cephalic birth not achieved and caesarean section. There is not enough evidence from randomised trials to assess complications of ECV at term. Large observational studies suggest that complications are rare.
BACKGROUND: Fetal movement counting is a method by which a woman quantifies the movements she feels to assess the condition of her baby. The purpose is to try to reduce perinatal mortality by alerting caregivers when the baby might be compromised. This method may be used routinely, or only in women who are considered at increased risk of complications affecting the baby. Fetal movement counting may allow the clinician to make appropriate interventions in good time to improve outcomes. On the other hand, fetal movement counting may cause unnecessary anxiety to pregnant women, or elicit unnecessary interventions.
OBJECTIVES: To assess outcomes of pregnancy where fetal movement counting was done routinely, selectively or was not done at all; and to compare different methods of fetal movement counting.
SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 May 2015) and reference lists of retrieved studies.
SELECTION CRITERIA: Randomised controlled trials (RCTs) and cluster-RCTs where fetal movement counting was assessed as a method of monitoring fetal wellbeing.
DATA COLLECTION AND ANALYSIS: Two review authors assessed studies for eligibility, assessed the methodological quality of included studies and independently extracted data from studies. Where possible the effects of interventions were compared using risk ratios (RR), and presented with 95% confidence intervals (CI). For some outcomes, the quality of the evidence was assessed using the GRADE approach.
MAIN RESULTS: Five studies (71,458 women) were included in this review; 68,654 in one cluster-RCT. None of these five trials were assessed as having low risk of bias on all seven risk of bias criteria. All included studies except for one (which included high-risk women as participants) included women with uncomplicated pregnancies.Two studies compared fetal movement counting with standard care, as defined by trial authors. Two included studies compared two types of fetal movement counting; once a day fetal movement counting (Cardiff count-to-10) with more than once a day fetal movement counting methods. One study compared fetal movement counting with hormone assessment.(1) Routine fetal movement counting versus mixed or undefined fetal movement countingNo study reported on the primary outcome 'perinatal death or severe morbidity'. In one large cluster-RCT, there was no difference in mean stillbirth rates per cluster (standard mean difference (SMD) 0.23, 95% CI -0.61 to 1.07; participants = 52 clusters; studies = one, low quality evidence). The other study reported no fetal deaths. There was no difference in caesarean section rate between groups (RR 0.93, 95% CI 0.60 to 1.44; participants = 1076; studies = one,low quality evidence). Maternal anxiety was significantly reduced with routine fetal movement counting (SMD -0.22, 95% CI -0.35 to -0.10; participants = 1013; studies = one, moderate quality evidence). Maternal-fetal attachment was not significantly different (SMD -0.02, 95% CI -0.15 to 0.11; participants = 951; studies = one, low quality evidence). In one study antenatal admission after reporting of decreased fetal movements was increased (RR 2.72, 95% CI 1.34 to 5.52; participants = 123; studies = one). In another there was a trend to more antenatal admissions per cluster in the counting group than in the control group (SMD 0.38, 95% CI -0.17 to 0.93; participants = 52 clusters; studies = one, low quality evidence). Birthweight less than 10th centile was not significantly different between groups (RR 0.98, 95% CI 0.66 to 1.44; participants = 1073; studies = one, low quality evidence). The evidence was of low quality due to imprecise results and because of concerns regarding unclear risk of bias. (2) Formal fetal movement counting (Modified Cardiff method) versus hormone analysisThere was no difference between the groups in the incidence of caesarean section (RR 1.18, 95% CI 0.83 to 1.69; participants = 1191; studies = one). Women in the formal fetal movement counting group had significantly fewer hospital visits than those randomised to hormone analysis (RR 0.26, 95% CI 0.20 to 0.35), whereas there were fewer Apgar scores less than seven at five minutes for women randomised to hormone analysis (RR 1.72, 95% CI 1.01 to 2.93). No other outcomes reported showed statistically significant differences. 'Perinatal death or severe morbidity' was not reported. (3) Formal fetal movement counting once a day (count-to-10) versus formal fetal movement counting method where counting was done more than once a day (after meals)The incidence of caesarean section did not differ between the groups under this comparison (RR 2.33, 95% CI 0.61 to 8.99; participants = 1400; studies = one). Perinatal death or severe morbidity was not reported. Women were more compliant in using the count-to-10 method than they were with other fetal movement counting methods, citing less interruption with daily activities as one of the reasons (non-compliance RR 0.25, 95% CI 0.19 to 0.32).Except for one cluster-RCT, included studies were small and used different comparisons, making it difficult to measure the outcomes using meta-analyses. The nature of the intervention measured also did not allow blinding of participants and clinicians..
AUTHORS' CONCLUSIONS: This review does not provide sufficient evidence to influence practice. In particular, no trials compared fetal movement counting with no fetal movement counting. Only two studies compared routine fetal movements with standard antenatal care, as defined by trial authors. Indirect evidence from a large cluster-RCT suggested that more babies at risk of death were identified in the routine fetal monitoring group, but this did not translate to reduced perinatal mortality. Robust research by means of studies comparing particularly routine fetal movement counting with selective fetal movement counting is needed urgently, as it is a common practice to introduce fetal movement counting only when there is already suspected fetal compromise.
BACKGROUND: Poor outcomes after breech birth might be the result of underlying conditions causing breech presentation or due to factors associated with the delivery.
OBJECTIVES: To assess the effects of planned caesarean section for singleton breech presentation at term on measures of pregnancy outcome.
SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 March 2015).
SELECTION CRITERIA: Randomised trials comparing planned caesarean section for singleton breech presentation at term with planned vaginal birth.
DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy.
MAIN RESULTS: Three trials (2396 participants) were included in the review. Caesarean delivery occurred in 550/1227 (45%) of those women allocated to a vaginal delivery protocol and 1060/1169 (91%) of those women allocated to planned caesarean section (average risk ratio (RR) random-effects, 1.88, 95% confidence interval (CI) 1.60 to 2.20; three studies, 2396 women, evidence graded low quality). Perinatal or neonatal death (excluding fatal anomalies) or severe neonatal morbidity was reduced with a policy of planned caesarean section in settings with a low national perinatal mortality rate (RR 0.07, 95% CI 0.02 to 0.29, one study, 1025 women, evidence graded moderate quality), but not in settings with a high national perinatal mortality rate (RR 0.66, 95% CI 0.35 to 1.24, one study, 1053 women, evidence graded low quality). The difference between subgroups was significant (Test for subgroup differences: Chi² = 8.01, df = 1 (P = 0.005), I² = 87.5%). Due to this significant heterogeneity, a random-effects analysis was performed. The average overall effect was not statistically significant (RR 0.23, 95% CI 0.02 to 2.44, one study, 2078 infants). Perinatal or neonatal death (excluding fatal anomalies) was reduced with planned caesarean section (RR 0.29, 95% CI 0.10 to 0.86, three studies, 2388 women). The proportional reductions were similar for countries with low and high national perinatal mortality rates.The numbers studied were too small to satisfactorily address reductions in birth trauma and brachial plexus injury with planned caesarean section. Neither of these outcomes reached statistical significance (birth trauma: RR 0.42, 95% CI 0.16 to 1.10, one study, 2062 infants (20 events),evidence graded low quality; brachial plexus injury: RR 0.35, 95% CI 0.08 to 1.47, three studies, 2375 infants (nine events)).Planned caesarean section was associated with modestly increased short-term maternal morbidity (RR 1.29, 95% CI 1.03 to 1.61, three studies, 2396 women,low quality evidence). At three months after delivery, women allocated to the planned caesarean section group reported less urinary incontinence (RR 0.62, 95% CI 0.41 to 0.93, one study, 1595 women); no difference in 'any pain' (RR 1.09, 95% CI 0.93 to 1.29, one study, 1593 women,low quality evidence); more abdominal pain (RR 1.89, 95% CI 1.29 to 2.79, one study, 1593 women); and less perineal pain (RR 0.32, 95% CI 0.18 to 0.58, one study, 1593 women).At two years, there were no differences in the combined outcome 'death or neurodevelopmental delay' (RR 1.09, 95% CI 0.52 to 2.30, one study, 920 children,evidence graded low quality); more infants who had been allocated to planned caesarean delivery had medical problems at two years (RR 1.41, 95% CI 1.05 to 1.89, one study, 843 children). Maternal outcomes at two years were also similar. In countries with low perinatal mortality rates, the protocol of planned caesarean section was associated with lower healthcare costs, expressed in 2002 Canadian dollars (mean difference -$877.00, 95% CI -894.89 to -859.11, one study, 1027 women).All of the trials included in this review had design limitations, and the GRADE level of evidence was mostly low. No studies attempted to blind the intervention, and the process of random allocation was suboptimal in two studies. Two of the three trials had serious design limitations, however these studies contributed to fewer outcomes than the large multi-centre trial with lower risk of bias.
AUTHORS' CONCLUSIONS: Planned caesarean section compared with planned vaginal birth reduced perinatal or neonatal death as well as the composite outcome death or serious neonatal morbidity, at the expense of somewhat increased maternal morbidity. In a subset with 2-year follow up, infant medical problems were increased following planned caesarean section and no difference in long-term neurodevelopmental delay or the outcome "death or neurodevelopmental delay" was found, though the numbers were too small to exclude the possibility of an important difference in either direction.The benefits need to be weighed against factors such as the mother's preference for vaginal birth and risks such as future pregnancy complications in the woman's specific healthcare setting. The option of external cephalic version is dealt with in separate reviews. The data from this review cannot be generalised to settings where caesarean section is not readily available, or to methods of breech delivery that differ materially from the clinical delivery protocols used in the trials reviewed. The review will help to inform individualised decision-making regarding breech delivery. Research on strategies to improve the safety of breech delivery and to further investigate the possible association of caesarean section with infant medical problems is needed.
BACKGROUND: Amnioinfusion is thought to dilute meconium present in the amniotic fluid and so reduce the risk of meconium aspiration.
OBJECTIVES: To assess the effects of amnioinfusion for meconium-stained liquor on perinatal outcome.
SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (1 December 2013).
SELECTION CRITERIA: Randomised trials comparing amnioinfusion with no amnioinfusion for women in labour with moderate or thick meconium staining of the amniotic fluid.
DATA COLLECTION AND ANALYSIS: Three review authors independently assessed eligibility and trial quality, and extracted data.
MAIN RESULTS: Fourteen studies of variable quality (4435 women) are included.
Subgroup analysis was performed for studies from settings with limited facilities to monitor the baby's condition during labour and intervene effectively, and settings with standard peripartum surveillance.
Settings with standard peripartum surveillance: there was considerable heterogeneity for several outcomes. There was no significant reduction in the primary outcomes meconium aspiration syndrome, perinatal death or severe morbidity, and maternal death or severe morbidity. There was a reduction in caesarean sections (CSs) for fetal distress but not overall. Meconium below the vocal cords diagnosed by laryngoscopy was reduced, as was neonatal ventilation or neonatal intensive care unit admission, but there was no significant reduction in perinatal deaths or other morbidity. Planned sensitivity analysis excluding trials with greater risk of bias resulted in an absence of benefits for any of the outcomes studied.
Settings with limited peripartum surveillance: three studies were included. In the amnioinfusion group there was a reduction in CS for fetal distress and overall; meconium aspiration syndrome (three studies, 1144 women; risk ratio (RR) 0.17, 95% confidence interval (CI) 0.05 to 0.52); perinatal mortality (three studies, 1151 women; RR 0.24, 95% CI 0.11 to 0.53) and neonatal ventilation or neonatal intensive care unit admission. In one of the studies, meconium below the vocal cords was reduced and, in the other, neonatal encephalopathy was reduced.
AUTHORS' CONCLUSIONS: Amnioinfusion is associated with substantive improvements in perinatal outcome only in settings where facilities for perinatal surveillance are limited. It is not clear whether the benefits are due to dilution of meconium or relief of oligohydramnios.
In settings with standard peripartum surveillance, some non-substantive outcomes were improved in the initial analysis, but sensitivity analysis excluding trials with greater risk of bias eliminated these differences. Amnioinfusion is either ineffective in this setting, or its effects are masked by other strategies to optimise neonatal outcome.
The trials reviewed are too small to address the possibility of rare but serious maternal adverse effects of amnioinfusion.
BACKGROUND: The optimal timing of birth for women with an otherwise uncomplicated twin pregnancy at term is uncertain, with clinical support for both elective delivery at 37 weeks, as well as expectant management (awaiting the spontaneous onset of labour).
OBJECTIVES: To assess a policy of elective delivery from 37 weeks' gestation compared with an expectant approach for women with an otherwise uncomplicated twin pregnancy.
SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (12 December 2013).
SELECTION CRITERIA: Randomised controlled trials with reported data that compared outcomes in mothers and babies who underwent elective delivery from 37 weeks' gestation in a twin pregnancy with outcomes in controls who were managed expectantly.
DATA COLLECTION AND ANALYSIS: At least two review authors independently assessed trial eligibility, trial quality and extracted data from the included trials.
MAIN RESULTS: Two randomised controlled trials comparing elective birth at 37 weeks for women with an uncomplicated twin pregnancy, with expectant management were included, involving 271 women and 542 infants. One trial was at an overall low risk of bias, and one trial was at unclear risk of selection bias, performance bias and detection bias.
There were no statistically significant differences identified between a policy of elective birth at 37 weeks' gestation and expectant management with regards to birth by caesarean section (two studies; 271 participants; risk ratio (RR) 1.05; 95% confidence interval (CI) 0.83 to 1.32); perinatal death or serious perinatal morbidity (two studies; 542 infants; RR 0.34; 95% CI 0.01 to 8.35); or maternal death or serious maternal morbidity (one study; 235 women; RR 0.29; 95% CI 0.06 to 1.38).
There were no statistically significant differences identified for the pre-specified secondary maternal and infant review outcomes reported by these two trials between the two treatment policies (including for: haemorrhage requiring blood transfusion; instrumental vaginal birth; meconium-stained liquor; Apgar score less than seven at five minutes; admission to neonatal intensive care; birthweight less than 2500 g; neonatal encephalopathy; and respiratory distress syndrome). While not a pre-specified review outcome, elective birth at 37 weeks, compared with expectant management, was shown to significantly reduce the risk of infants being born with a birthweight less than the third centile (one study; 470 infants; RR 0.30; 95% CI 0.13 to 0.68).
AUTHORS' CONCLUSIONS: Early birth at 37 weeks' gestation compared with ongoing expectant management for women with an uncomplicated twin pregnancy does not appear to be associated with an increased risk of harms, findings which are consistent with the United Kingdom's National Institute for Health and Care Excellence (NICE) recommendations which advocate birth for women with a dichorionic twin pregnancy at 37 + 0 weeks' gestation. It is unlikely that sufficient clinical equipoise exists to allow for the randomisation of women to a later gestational age at birth.
BACKGROUND: Prelabour rupture of the membranes (PROM) at or near term (defined in this review as 36 weeks' gestation or beyond) increases the risk of infection for the woman and her baby. The routine use of antibiotics for women at the time of term PROM may reduce this risk. However, due to increasing problems with bacterial resistance and the risk of maternal anaphylaxis with antibiotic use, it is important to assess the evidence addressing risks and benefits in order to ensure judicious use of antibiotics. This review was undertaken to assess the balance of risks and benefits to the mother and infant of antibiotic prophylaxis for PROM at or near term.
OBJECTIVES: To assess the effects of antibiotics administered prophylactically to women with PROM at 36 weeks' gestation or beyond, on maternal, fetal and neonatal outcomes.
SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 July 2014).
SELECTION CRITERIA: All randomised trials that compared outcomes for women and infants when antibiotics were administered prophylactically for prelabour rupture of the membranes at or near term, with outcomes for controls (placebo or no antibiotic).
DATA COLLECTION AND ANALYSIS: Two review authors independently extracted the data and assessed risk of bias in the included studies. Additional data were received from the investigators of included studies.
MAIN RESULTS: This update includes an additional two studies involving 1801 women, giving a total of four included studies of 2639 women. Whereas the previous version of this review showed a statistically significant reduction in endometritis with the use of antibiotics, no such effect was shown in this update (average risk ratio (RR) 0.34, 95% confidence interval (CI) 0.05 to 2.31). No differences were shown on the primary outcome measures of probable early-onset neonatal sepsis (average RR 0.69, 95%; CI 0.21 to 2.33); definite early-onset neonatal sepsis (average RR 0.57, 95% CI 0.08 to 4.26); maternal infectious morbidity (chorioamnionitis and/or endometritis) (average RR 0.48, 95% CI 0.20 to 1.15); stillbirth (RR 3.00, 95% CI 0.61 to 14.82); and perinatal mortality (RR 1.98, 95% CI 0.60 to 6.55), though the number of cases in the control group for these outcomes was low. There were no cases of neonatal mortality or serious maternal outcome in the studies assessed. Caesarean section was increased with the use of antibiotics (RR 1.33, 95% CI 1.09 to 1.61) as was duration of maternal stay in hospital (mean difference (MD) 0.06 days, 95% CI 0.01 to 0.11), largely owing to one study of 1640 women where repeat caesarean section, increased baseline hypertension and pre-eclampsia were evident in the antibiotic group, despite random allocation and allocation concealment.Subgroup analyses by timing of induction (early induction versus late induction) showed no difference in either probable or definite early-onset neonatal sepsis in the early induction group (RR 1.47, 95% CI 0.80 to 2.70 and RR 1.29, 95% CI 0.48 to 3.44, respectively) or the late induction group (RR 0.14, 95% CI 0.02 to 1.13 and RR 0.16, 95% CI 0.02 to 1.34, respectively), although there were trends toward reduced probable and definite early-onset neonatal sepsis in the late induction group. A test for subgroup differences confirmed a differential effect of the intervention on probable early-onset neonatal sepsis between the subgroups (Chi² = 4.50, df = 1 (P = 0.03), I² = 77.8%). No difference in maternal infectious morbidity (chorioamnionitis and/or endometritis) was found in either subgroup, though again there was a trend towards reduced maternal infectious morbidly in the late induction group (average RR 0.34, 95% CI 0.08 to 1.47). No differences were shown in stillbirth or perinatal mortality. The quality of the evidence for the primary outcomes using GRADE was judged to be low to very low.
AUTHORS' CONCLUSIONS: This updated review demonstrates no convincing evidence of benefit for mothers or neonates from the routine use of antibiotics for PROM at or near term. We are unable to adequately assess the risk of short- and long-term harms from the use of antibiotics due to the unavailability of data. Given the unmeasured potential adverse effects of antibiotic use, the potential for the development of resistant organisms, and the low risk of maternal infection in the control group, the routine use of antibiotics for PROM at or near term in the absence of confirmed maternal infection should be avoided.
Women with a suspected large-for-dates fetus or a fetus with suspected macrosomia (birthweight greater than 4000 g) are at risk of operative birth or caesarean section. The baby is also at increased risk of shoulder dystocia and trauma, in particular fractures and brachial plexus injury. Induction of labour may reduce these risks by decreasing the birthweight, but may also lead to longer labours and an increased risk of caesarean section.
OBJECTIVES:
To assess the effects of a policy of labour induction at or shortly before term (37 to 40 weeks) for suspected fetal macrosomia on the way of giving birth and maternal or perinatal morbidity.
SEARCH METHODS:
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 January 2016), contacted trial authors and searched reference lists of retrieved studies.
SELECTION CRITERIA:
Randomised trials of induction of labour for suspected fetal macrosomia.
DATA COLLECTION AND ANALYSIS:
Review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. We contacted study authors for additional information. For key outcomes the quality of the evidence was assessed using the GRADE approach.
MAIN RESULTS:
We included four trials, involving 1190 women. It was not possible to blind women and staff to the intervention, but for other 'Risk of bias' domains these studies were assessed as being at low or unclear risk of bias. Compared to expectant management, there was no clear effect of induction of labour for suspected macrosomia on the risk of caesarean section (risk ratio (RR) 0.91, 95% confidence interval (CI) 0.76 to 1.09; 1190 women; four trials, moderate-quality evidence) or instrumental delivery (RR 0.86, 95% CI 0.65 to 1.13; 1190 women; four trials, low-quality evidence). Shoulder dystocia (RR 0.60, 95% CI 0.37 to 0.98; 1190 women; four trials, moderate-quality evidence), and fracture (any) (RR 0.20, 95% CI 0.05 to 0.79; 1190 women; four studies, high-quality evidence) were reduced in the induction of labour group. There were no clear differences between groups for brachial plexus injury (two events were reported in the control group in one trial, low-quality evidence). There was no strong evidence of any difference between groups for measures of neonatal asphyxia; low five-minute infant Apgar scores (less than seven) or low arterial cord blood pH (RR 1.51, 95% CI 0.25 to 9.02; 858 infants; two trials, low-quality evidence; and, RR 1.01, 95% CI 0.46 to 2.22; 818 infants; one trial, moderate-quality evidence, respectively). Mean birthweight was lower in the induction group, but there was considerable heterogeneity between studies for this outcome (mean difference (MD) -178.03 g, 95% CI -315.26 to -40.81; 1190 infants; four studies; I2 = 89%). For outcomes assessed using GRADE, we based our downgrading decisions on high risk of bias from lack of blinding and imprecision of effect estimates.
AUTHORS' CONCLUSIONS:
Induction of labour for suspected fetal macrosomia has not been shown to alter the risk of brachial plexus injury, but the power of the included studies to show a difference for such a rare event is limited. Also antenatal estimates of fetal weight are often inaccurate so many women may be worried unnecessarily, and many inductions may not be needed. Nevertheless, induction of labour for suspected fetal macrosomia results in a lower mean birthweight, and fewer birth fractures and shoulder dystocia. The observation of increased use of phototherapy in the largest trial, should also be kept in mind. Findings from trials included in the review suggest that to prevent one fracture it would be necessary to induce labour in 60 women. Since induction of labour does not appear to alter the rate of caesarean delivery or instrumental delivery, it is likely to be popular with many women. In settings where obstetricians can be reasonably confident about their scan assessment of fetal weight, the advantages and disadvantages of induction at or near term for fetuses suspected of being macrosomic should be discussed with parents. Although some parents and doctors may feel the evidence already justifies induction, others may justifiably disagree. Further trials of induction shortly before term for suspected fetal macrosomia are needed. Such trials should concentrate on refining the optimum gestation of induction, and improving the accuracy of the diagnosis of macrosomia.
