Twin Birth Study: 2-year neurodevelopmental follow-up of the randomized trial of planned cesarean or planned vaginal delivery for twin pregnancy.

BACKGROUND: The Twin Birth Study randomized women with uncomplicated pregnancies, between 32(0/7)-38(6/7) weeks' gestation where the first twin was in cephalic presentation, to a policy of either a planned cesarean or planned vaginal delivery. The primary analysis showed that planned cesarean delivery did not increase or decrease the risk of fetal/neonatal death or serious neonatal morbidity as compared with planned vaginal delivery. OBJECTIVE: This study presents the secondary outcome of death or neurodevelopmental delay at 2 years of age. STUDY DESIGN: A total of 4603 children from the initial cohort of 5565 fetuses/infants (83%) contributed to the outcome of death or neurodevelopmental delay. Surviving children were screened using the Ages and Stages Questionnaire with abnormal scores validated by a clinical neurodevelopmental assessment. The effect of planned cesarean vs planned vaginal delivery on death or neurodevelopmental delay was quantified using a logistic model to control for stratification variables and using generalized estimating equations to account for the nonindependence of twin births. RESULTS: Baseline maternal, pregnancy, and infant characteristics were similar. Mean age at assessment was 26 months. There was no significant difference in the outcome of death or neurodevelopmental delay: 5.99% in the planned cesarean vs 5.83% in the planned vaginal delivery group (odds ratio, 1.04; 95% confidence interval, 0.77-1.41; P = .79). CONCLUSION: A policy of planned cesarean delivery provides no benefit to children at 2 years of age compared with a policy of planned vaginal delivery in uncomplicated twin pregnancies between 32(0/7)-38(6/7)weeks' gestation where the first twin is in cephalic presentation.

A randomized trial of planned cesarean or vaginal delivery for twin pregnancy.

BACKGROUND: Twin birth is associated with a higher risk of adverse perinatal outcomes than singleton birth. It is unclear whether planned cesarean section results in a lower risk of adverse outcomes than planned vaginal delivery in twin pregnancy. METHODS: We randomly assigned women between 32 weeks 0 days and 38 weeks 6 days of gestation with twin pregnancy and with the first twin in the cephalic presentation to planned cesarean section or planned vaginal delivery with cesarean only if indicated. Elective delivery was planned between 37 weeks 5 days and 38 weeks 6 days of gestation. The primary outcome was a composite of fetal or neonatal death or serious neonatal morbidity, with the fetus or infant as the unit of analysis for the statistical comparison. RESULTS: A total of 1398 women (2795 fetuses) were randomly assigned to planned cesarean delivery and 1406 women (2812 fetuses) to planned vaginal delivery. The rate of cesarean delivery was 90.7% in the planned-cesarean-delivery group and 43.8% in the planned-vaginal-delivery group. Women in the planned-cesarean-delivery group delivered earlier than did those in the planned-vaginal-delivery group (mean number of days from randomization to delivery, 12.4 vs. 13.3; P=0.04). There was no significant difference in the composite primary outcome between the planned-cesarean-delivery group and the planned-vaginal-delivery group (2.2% and 1.9%, respectively; odds ratio with planned cesarean delivery, 1.16; 95% confidence interval, 0.77 to 1.74; P=0.49). CONCLUSIONS: In twin pregnancy between 32 weeks 0 days and 38 weeks 6 days of gestation, with the first twin in the cephalic presentation, planned cesarean delivery did not significantly decrease or increase the risk of fetal or neonatal death or serious neonatal morbidity, as compared with planned vaginal delivery. (Funded by the Canadian Institutes of Health Research; ClinicalTrials.gov number, NCT00187369; Current Controlled Trials number, ISRCTN74420086.).

Repeat prenatal corticosteroid prior to preterm birth: a systematic review and individual participant data meta-analysis for the PRECISE study group (prenatal repeat corticosteroid international IPD study group: assessing the effects using the best level of evidence) - study protocol.

BACKGROUND: The aim of this individual participant data (IPD) meta-analysis is to assess whether the effects of repeat prenatal corticosteroid treatment given to women at risk of preterm birth to benefit their babies are modified in a clinically meaningful way by factors related to the women or the trial protocol. METHODS/DESIGN: The Prenatal Repeat Corticosteroid International IPD Study Group: assessing the effects using the best level of Evidence (PRECISE) Group will conduct an IPD meta-analysis. The PRECISE International Collaborative Group was formed in 2010 and data collection commenced in 2011. Eleven trials with up to 5,000 women and 6,000 infants are eligible for the PRECISE IPD meta-analysis. The primary study outcomes for the infants will be serious neonatal outcome (defined by the PRECISE International IPD Study Group as one of death (foetal, neonatal or infant); severe respiratory disease; severe intraventricular haemorrhage (grade 3 and 4); chronic lung disease; necrotising enterocolitis; serious retinopathy of prematurity; and cystic periventricular leukomalacia); use of respiratory support (defined as mechanical ventilation or continuous positive airways pressure or other respiratory support); and birth weight (Z-scores). For the children, the primary study outcomes will be death or any neurological disability (however defined by trialists at childhood follow up and may include developmental delay or intellectual impairment (developmental quotient or intelligence quotient more than one standard deviation below the mean), cerebral palsy (abnormality of tone with motor dysfunction), blindness (for example, corrected visual acuity worse than 6/60 in the better eye) or deafness (for example, hearing loss requiring amplification or worse)). For the women, the primary outcome will be maternal sepsis (defined as chorioamnionitis; pyrexia after trial entry requiring the use of antibiotics; puerperal sepsis; intrapartum fever requiring the use of antibiotics; or postnatal pyrexia). DISCUSSION: Data analyses are expected to commence in 2011 with results publicly available in 2012.

Effect of antenatal corticosteroids on fetal growth and gestational age at birth.

OBJECTIVE: To estimate the effect of multiple courses of antenatal corticosteroids on neonatal size, controlling for gestational age at birth and other confounders, and to determine whether there was a dose-response relationship between number of courses of antenatal corticosteroids and neonatal size. METHODS: This is a secondary analysis of the Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study, a double-blind randomized controlled trial of single compared with multiple courses of antenatal corticosteroids in women at risk for preterm birth and in which fetuses administered multiple courses of antenatal corticosteroids weighed less, were shorter, and had smaller head circumferences at birth. All women (n=1,858) and children (n=2,304) enrolled in the Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study were included in the current analysis. Multiple linear regression analyses were undertaken. RESULTS: Compared with placebo, neonates in the antenatal corticosteroids group were born earlier (estimated difference and confidence interval [CI]: -0.428 weeks, CI -0.10264 to -0.75336; P=.01). Controlling for gestational age at birth and confounding factors, multiple courses of antenatal corticosteroids were associated with a decrease in birth weight (-33.50 g, CI -66.27120 to -0.72880; P=.045), length (-0.339 cm, CI -0.6212 to -0.05676]; P=.019), and head circumference (-0.296 cm, -0.45672 to -0.13528; P<.001). For each additional course of antenatal corticosteroids, there was a trend toward an incremental decrease in birth weight, length, and head circumference. CONCLUSION: Fetuses exposed to multiple courses of antenatal corticosteroids were smaller at birth. The reduction in size was partially attributed to being born at an earlier gestational age but also was attributed to decreased fetal growth. Finally, a dose-response relationship exists between the number of corticosteroid courses and a decrease in fetal growth. The long-term effect of these findings is unknown. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00187382. LEVEL OF EVIDENCE: II.

Maternal side-effects after multiple courses of antenatal corticosteroids (MACS): the three-month follow-up of women in the randomized controlled trial of MACS for preterm birth study.

OBJECTIVE: A single course of antenatal corticosteroids (ACS) is associated with a reduction in respiratory distress syndrome and neonatal death. Multiple Courses of Antenatal Corticosteroids Study (MACS), a study involving 1858 women, was a multicentre randomized placebo-controlled trial of multiple courses of ACS, given every 14 days until 33+6 weeks or birth, whichever came first. The primary outcome of the study, a composite of neonatal mortality and morbidity, was similar for the multiple ACS and placebo groups (12.9% vs. 12.5%), but infants exposed to multiple courses of ACS weighed less, were shorter, and had smaller head circumferences. Thus for women who remain at increased risk of preterm birth, multiple courses of ACS (every 14 days) are not recommended. Chronic use of corticosteroids is associated with numerous side effects including weight gain and depression. The aim of this postpartum assessment was to ascertain if multiple courses of ACS were associated with maternal side effects. METHODS: Three months postpartum, women who participated in MACS were asked to complete a structured questionnaire that asked about maternal side effects of corticosteroid use during MACS and included the Edinburgh Postnatal Depression Scale. Women were also asked to evaluate their study participation. RESULTS: Of the 1858 women randomized, 1712 (92.1%) completed the postpartum questionnaire. There were no significant differences in the risk of maternal side effects between the two groups. Large numbers of women met the criteria for postpartum depression (14.1% in the ACS vs. 16.0% in the placebo group). Most women (94.1%) responded that they would participate in the trial again. CONCLUSION: In pregnancy, corticosteroids are given to women for fetal lung maturation and for the treatment of various maternal diseases. In this international multicentre randomized controlled trial, multiple courses of ACS (every 14 days) were not associated with maternal side effects, and the majority of women responded that they would participate in such a study again.

Multiple courses of antenatal corticosteroids for preterm birth study: 2-year outcomes.

OBJECTIVE: The aim of this study was to determine the effects of repeated courses of prenatal corticosteroid therapy versus placebo on death or neurologic impairment among the children enrolled in the Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study, at 18 to 24 months of age. METHODS: A total of 2305 infants were eligible for follow-up evaluation; 2104 infants (1069 in the prenatal corticosteroid therapy group and 1035 in the placebo group) were monitored. The primary outcome was death or neurologic impairment, defined as either cerebral palsy or cognitive delay, at 18 to 24 months of age. The secondary outcomes were measurements of growth (height, weight, and head circumference). RESULTS: Children exposed to multiple courses of prenatal corticosteroid therapy had similar rates of death or neurologic impairment, compared with children exposed to placebo (148 children [13.8%] vs 142 children [13.7%]; odds ratio: 1.001[95% confidence interval: 0.75-1.30]; P = .95). They had a mean weight of 11.94 kg, compared with 12.14 kg in the placebo group (P = .04), a mean height of 85.51 cm, compared with 85.46 cm (P = .87), and a mean head circumference of 48.18 cm, compared with 48.25 cm (P = .45). CONCLUSIONS: Multiple courses of prenatal corticosteroid therapy, given every 14 days, did not increase or decrease the risk of death or neurologic impairment at 18 to 24 months of age, compared with a single course of prenatal corticosteroid therapy. Continued follow-up monitoring of these children is necessary to assess neurobehavioral function, school performance, and possible susceptibility to disease.

Multiple courses of antenatal corticosteroids for preterm birth (MACS): a randomised controlled trial.

BACKGROUND: One course of antenatal corticosteroids reduces the risk of respiratory distress syndrome and neonatal death. Weekly doses given to women who remain undelivered after a single course may have benefits (less respiratory morbidity) or cause harm (reduced growth in utero). We aimed to find out whether multiple courses of antenatal corticosteroids would reduce neonatal morbidity and mortality without adversely affecting fetal growth. METHODS: 1858 women at 25-32 weeks' gestation who remained undelivered 14-21 days after an initial course of antenatal corticosteroids and continued to be at high risk of preterm birth were randomly assigned to multiple courses of antenatal corticosteroids (n=937) or placebo (n=921), every 14 days until week 33 or delivery, whichever came first. The primary outcome was a composite of perinatal or neonatal mortality, severe respiratory distress syndrome, intraventricular haemorrhage (grade III or IV), periventricular leucomalacia, bronchopulmonary dysplasia, or necrotising enterocolitis. Analysis was by intention to treat. All patients and caregivers were unaware of the treatment given. This trial is registered as number ISRCTN2654148. FINDINGS: Infants exposed to multiple courses of antenatal corticosteroids had similar morbidity and mortality to those exposed to placebo (150 [12.9%] vs 143 [12.5%]). Those receiving multiple doses of corticosteroids also weighed less at birth than those exposed to placebo (2216 g vs 2330 g, p=0.0026), were shorter (44.5 cm vs 45.4 cm, p<0.001), and had a smaller head circumference (31.1 cm vs 31.7 cm, p<0.001). INTERPRETATION: Multiple courses of antenatal corticosteroids, every 14 days, do not improve preterm-birth outcomes, and are associated with a decreased weight, length, and head circumference at birth. Therefore, this treatment schedule is not recommended. FUNDING: Canadian Institutes of Health Research.

Factors associated with maternal morbidity in the Term Breech Trial.

OBJECTIVE: In the Term Breech Trial, the risk of maternal morbidity in women who delivered after planning for a caesarean section (CS) was not significantly different from those who delivered after planning for a vaginal birth. We undertook secondary analyses to determine factors associated with maternal morbidity among 2078 women. METHODS: By using multiple logistic regression analyses, we determined the effect of prelabour CS, CS during early labour, CS during active labour, vaginal birth, and other factors on maternal morbidity. For 1536 women delivered after labour, we determined the effect of variables associated with labour on maternal morbidity. RESULTS: The risk of maternal morbidity was lowest following vaginal birth (odds ratio [OR] 1.0) and highest following CS during active labour (OR 3.33; 95% confidence intervals [CI] 1.75-6.33, P < 0.001). For those delivered after labour, a short active phase of the second stage of labour (< 30 minutes) was associated with the lowest risk of maternal morbidity (OR 0.25; 95% CI 0.11-0.57, P < 0.001). CONCLUSION: For women with a singleton fetus in breech resentation at term, maternal morbidity is lowest following vaginal birth and highest following CS during active labour.

Preterm labour and birth: a survey of clinical practice regarding use of tocolytics, antenatal corticosteroids, and progesterone.

OBJECTIVES: We wished to determine prescribing practices of obstetricians in Canada regarding tocolytics, antenatal corticosteroids, and progesterone for women at increased risk of preterm labour and birth, and to determine whether these practices changed between 1997-98 and 2004. METHODS: Two cross-sectional surveys of Canadian obstetricians were conducted. The initial survey was in 1997-98 (N = 1313); the follow-up survey was in 2004 (N = 1508). RESULTS: Response rates were 46.4% in 1997-98 and 43.3% in 2004. Most respondents reported that they prescribed tocolytics to women with signs and symptoms of preterm labour (97.4% in 1997-98; 92.2% in 2004; P < 0.001) but use had decreased. In 1997-98, 20.0% of respondents used tocolytics for > 48 hours during one course of treatment, whereas in 2004, only 9.6% did this (P = 0.06). The tocolytic prescribed most frequently was magnesium sulphate in 1997-98 (40.6% of respondents), whereas in 2004, it was indomethacin (47.5% of respondents). The use of repeat courses of antenatal corticosteroids decreased from 72.9% in 1997-98 to 18.7% in 2004 (P < 0.001). In 2004, only a few respondents (7.0%) prescribed progesterone for women at increased risk of preterm birth. CONCLUSIONS: Most Canadian obstetricians continue to use tocolytics for women in preterm labour, although use has decreased over time, and the most frequently prescribed tocolytic has changed from magnesium sulphate to indomethacin. The use of repeat courses of antenatal corticosteroids decreased substantially during this time, and in 2004, progesterone was not in frequent use.

Progesterone for the prevention of preterm birth among women at increased risk: a systematic review and meta-analysis of randomized controlled trials.

OBJECTIVE: This study was undertaken to determine whether progestational agents, initiated in the second trimester of pregnancy, reduce the risk of delivery less than 37 weeks, among women at increased risk of spontaneous preterm birth. STUDY DESIGN: Medline, pre-Medline, EMBASE, and Cochrane Central Register of Controlled Trials were searched. Randomized controlled trials with less than 20% lost to follow-up were included. RESULTS: Three trials were eligible for inclusion. There was a significant reduction in risk of delivery less than 37 weeks with progestational agents (relative risk [95% CI] = 0.57 [0.36-0.90]). There was no significant effect on perinatal mortality or serious neonatal morbidity. CONCLUSION: Progestational agents, initiated in the second trimester of pregnancy, may reduce the risk of delivery less than 37 weeks' gestation, among women at increased risk of spontaneous preterm birth, but the effect on neonatal outcome is uncertain. Larger randomized controlled trials are required to determine whether this treatment reduces perinatal mortality or serious neonatal morbidity.

The costs of planned cesarean versus planned vaginal birth in the Term Breech Trial.

BACKGROUND: The Term Breech Trial compared the safety of planned cesarean and planned vaginal birth for breech presentations at term. The combined outcome of perinatal or neonatal death and serious neonatal morbidity was found to be significantly lower among babies delivered by planned cesarean section. In this study we conducted a cost analysis of the 2 approaches to breech presentations at delivery. METHODS: We used a third-party-payer (i.e., Ministry of Health) perspective. We included all costs for physician services and all hospital-related costs incurred by both the mother and the infant. We collected health care utilization and outcomes for all study participants during the trial. We used only the utilization data from countries with low national rates of perinatal death (< or = 20/1000). Seven hospitals across Canada (4 teaching and 3 community centres) were selected for unit cost calculations. RESULTS: The estimated mean cost of a planned cesarean was significantly lower than that of a planned vaginal birth (7165 dollars v. 8042 dollars per mother and infant; mean difference -877 dollars, 95% credible interval -1286 dollars to -473 dollars). The estimated mean cost of a planned cesarean was lower than that of a planned vaginal birth for both women having a first birth (7255 dollars v. 8440 dollars) and women having had at least one prior birth (7071 dollars v. 7559 dollars). Although the treatment effect was largest in the subgroup of women having their first child, there was no statistically significant interaction between treatment and parity since the 95% credible intervals for difference in treatment effects between parity equalling zero and parity of one or greater all include zero. INTERPRETATION: Planned cesarean section was found to be less costly than planned vaginal birth for the singleton fetus in a breech presentation at term in the Term Breech Trial.

Mothers' views of their childbirth experiences 2 years after planned Caesarean versus planned vaginal birth for breech presentation at term, in the international randomized Term Breech Trial.

OBJECTIVE: To compare mothers' views at 2 years postpartum after participation in a randomized trial of planned Caesarean and planned vaginal birth for a singleton fetus in breech presentation at term. STUDY DESIGN: In selected centres in the Term Breech Trial, mothers completed a structured questionnaire at approximately 2 years postpartum to assess their likes and dislikes about their childbirth experiences and their views about their intrapartum care and care providers. RESULTS: Of 1159 mothers from 85 centres, 917 (79.1%) completed a follow-up questionnaire at 2 years postpartum. Baseline information was similar for both the planned Caesarean and planned vaginal birth groups. Planned Caesarean was associated with less worry about the baby's health (P < 0.001). While other differences were noted in likes and dislikes about their childbirth experiences, women's evaluations of the quality of intrapartum care, the helpfulness of staff, and their involvement in decision-making did not differ in the planned Caesarean delivery and planned vaginal birth groups. CONCLUSION: Planned mode of delivery influences aspects of women's evaluations of their childbirth experiences but does not affect evaluations of the quality of intrapartum care, support from care providers, or amount of involvement in decision-making.

The effect of unrestricted oral carbohydrate intake on labor progress.

OBJECTIVE: To determine if unrestricted oral carbohydrate intake during labor reduced the incidence of dystocia in low-risk nulliparous women. DESIGN AND SETTING: A randomized clinical trial at a university-affiliated hospital in southeastern Ontario. Low-risk nulliparous women were randomized between 30 and 40 weeks gestation to either an intervention or usual care group. INTERVENTION: Women in the intervention group received, prenatally, guidelines about food and fluid intake during labor and were encouraged to eat and drink as they pleased during labor. Women in the usual care group received no prelabor information and were restricted to ice chips and water during labor in the hospital. MAIN OUTCOME MEASURE: The incidence of dystocia, defined as a cervical dilatation rate of less than 0.5 cm/hr for a period of 4 hrs after a cervical dilatation of 3 cm. RESULTS: Three hundred twenty-eight women were randomized to the intervention (n = 163) or usual care (n = 165) groups. Women in the intervention group reported a significantly different pattern of oral intake during early labor in the hospital (chi(2) = 40.7, p < .001). The incidence of dystocia was 36% (n = 58) in the intervention group and 44% (n = 72) in the usual care group and was not significantly different (OR = 0.71, 95% CI = 0.46, 1.11). There were no significant differences in the other secondary outcomes or in the incidence of adverse maternal or neonatal complications. CONCLUSION: Eating and drinking early in labor had no significant impact on the incidence of dystocia and/or adverse maternal or neonatal outcomes.

Antibiotics for bacterial vaginosis or Trichomonas vaginalis in pregnancy: a systematic review.

OBJECTIVE: To determine whether antibiotic treatment for bacterial vaginosis or Trichomonas vaginalis during pregnancy decreases the risk of preterm birth and associated adverse outcomes. DATA SOURCES: Pre-MEDLINE and MEDLINE (1966-2003), EMBASE (1980-2003), and the Cochrane Library were searched using the keywords "bacterial vaginosis", "Trichomonas", "Trichomonas vaginalis", "Trichomonas vaginitis", "Trichomonas infections", "pregnancy", "pregnant", "antibiotics", and "antibiotic prophylaxis". METHODS OF STUDY SELECTION: The search produced 1,888 titles, of which 1,256 abstracts were reviewed further. Of these, 1,217 were ineligible. Inclusion criteria were the following: randomized controlled trials in which antibiotics were compared with no antibiotic or placebo, for women in the second or third trimester of pregnancy with symptomatic or asymptomatic bacterial vaginosis or Trichomonas vaginalis, intact membranes, and not in labor. Exclusion criteria were as follows: published in a language other than English, dropout rate of more than 20% of women in either group, and lack of usable outcomes. Of the 39 papers reviewed in detail, 14 studies were included in the meta-analysis. TABULATION, INTEGRATION, AND RESULTS: One of the authors reviewed titles obtained from the searches, and 2 reviewers independently reviewed the abstracts, excluded those that were ineligible, identified eligible papers, and abstracted the data. For women with bacterial vaginosis, antibiotics reduced the risk of persistent infection but did not reduce the risk of preterm birth or the incidence of associated adverse outcomes for the general population or for any subgroup analyzed. For women with Trichomonas vaginalis, metronidazole reduced the risk of persistent infection but increased the incidence of preterm birth. CONCLUSION: Contrary to the conclusions of 3 recent systematic reviews, we found no evidence to support the use of antibiotic treatment for bacterial vaginosis or Trichomonas vaginalis in pregnancy to reduce the risk of preterm birth or its associated morbidities in low- or high-risk women.

Outcomes of children at 2 years after planned cesarean birth versus planned vaginal birth for breech presentation at term: the International Randomized Term Breech Trial.

OBJECTIVE: The purpose of this study was to determine whether planned cesarean delivery for the singleton fetus in breech presentation at term reduces the risk of death or neurodevelopmental delay at 2 years of age. STUDY DESIGN: In selected centers in the Term Breech Trial, children were screened for abnormalities at > or =2 years of age with the Ages and Stages Questionnaire, followed by a neurodevelopmental assessment if the Ages and Stages Questionnaire score was abnormal. RESULTS: A total of 923 of 1159 children (79.6%) from 85 centers were followed to 2 years of age. The risk of death or neurodevelopmental delay was no different for the planned cesarean than for the planned vaginal birth groups (14 children [3.1%] vs 13 children [2.8%]; relative risk, 1.09; 95% CI, 0.52- 2.30; P = .85; risk difference, +0.3%; 95% CI, -1.9%, +2.4%). CONCLUSION: Planned cesarean delivery is not associated with a reduction in risk of death or neurodevelopmental delay in children at 2 years of age.

Maternal outcomes at 2 years after planned cesarean section versus planned vaginal birth for breech presentation at term: the international randomized Term Breech Trial.

OBJECTIVE: This study was undertaken to compare maternal outcomes at 2 years postpartum after planned cesarean section and planned vaginal birth for the singleton fetus in breech presentation at term. STUDY DESIGN: In selected centers in the Term Breech Trial, mothers completed a structured questionnaire at 2 or more years postpartum to determine their health in the previous 3 to 6 months. RESULTS: A total of 917 of 1159 (79.1%) mothers from 85 centers completed a follow-up questionnaire at 2 years postpartum. There were no differences between groups in breast feeding, relationship with child or partner, pain, subsequent pregnancy, incontinence, depression, urinary, menstrual or sexual problems, fatigue, or distressing memories of the birth experience. Planned cesarean section was associated with a higher risk of constipation (P = .02). CONCLUSION: Maternal outcomes at 2 years postpartum are similar after planned cesarean section and planned vaginal birth for the singleton breech fetus at term.

Planned caesarean section decreases the risk of adverse perinatal outcome due to both labour and delivery complications in the Term Breech Trial.

OBJECTIVE: To determine if the decreased risk of adverse perinatal outcome, with a policy of planned caesarean, in the Term Breech Trial, was due to a reduction of problems of labour, problems of delivery or unrelated problems. DESIGN: Secondary analysis of data from the Term Breech Trial, a randomised controlled trial of planned caesarean versus planned vaginal birth for the singleton fetus in frank or complete breech presentation at term. SETTING: Women were recruited from 121 centres in 26 countries. POPULATION: Women who were enrolled in the Term Breech Trial. METHODS: Adverse perinatal outcome was classified as due to labour, due to delivery, due to neither labour nor delivery or unexplained by an experienced obstetrician who was masked to allocation group. The risk of an adverse outcome in each category was compared according to intention to treat and also by actual method of delivery. MAIN OUTCOME MEASURES: Adverse perinatal outcome (excluding lethal congenital anomalies) that was due to labour, due to delivery, due to neither labour nor delivery or unexplained. RESULTS: Planned caesarean was associated with a lower risk of adverse outcome due to both labour (RR 0.14, 95% CI 0.04-0.45, P < 0.001) and delivery (RR 0.37, 95% CI 0.16-0.87, P= 0.03), compared with planned vaginal birth. Prelabour caesarean and caesarean during early labour were associated with the lowest risk and vaginal birth was associated with the highest risk of adverse outcome due to both labour (0%, 0.4% and 2.2%, respectively) and delivery (0.2%, 0% and 3.1%, respectively). CONCLUSIONS: Planned caesarean decreases the risk of adverse perinatal outcome due to both problems of labour and problems of delivery for the singleton fetus in breech presentation at term, compared with planned vaginal birth.