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

ABSTRACT: 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.).

SUBMITTER: Barrett JF

PROVIDER: S-EPMC3954096 | biostudies-literature | 2013 Oct

REPOSITORIES: biostudies-literature

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

Barrett Jon F R JF Hannah Mary E ME Hutton Eileen K EK Willan Andrew R AR Allen Alexander C AC Armson B Anthony BA Gafni Amiram A Joseph K S KS Mason Dalah D Ohlsson Arne A Ross Susan S Sanchez J Johanna JJ Asztalos Elizabeth V EV

The New England journal of medicine 20131001 14

<h4>Background</h4>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.<h4>Methods</h4>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 onl ...[more]

PMID: 24088091

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Project description:ObjectiveTo evaluate whether there is a differential benefit of planned Cesarean delivery (CD) over planned vaginal delivery (VD) in women with a twin pregnancy and the first twin in cephalic presentation, depending on prespecified baseline maternal and pregnancy characteristics, and/or gestational age (GA) at delivery.MethodsThis was a secondary analysis of the Twin Birth Study, which included 2804 women with a twin pregnancy and the first twin (Twin A) in cephalic presentation between 32 + 0 and 38 + 6 weeks' gestation at 106 centers in 25 countries. Women were assigned randomly to either planned CD or planned VD. The main outcome measure was composite adverse perinatal outcome, defined as the occurrence of perinatal mortality or serious neonatal morbidity in at least one twin. The baseline maternal and pregnancy characteristics (markers) considered were maternal age, parity, history of CD, use of antenatal corticosteroids, estimated fetal weight (EFW) of Twin A, EFW of Twin B, > 25% difference in EFW between the twins, presentation of Twin B, chorionicity on ultrasound, method of conception, complications of pregnancy, ruptured membranes at randomization and GA at randomization. Separate logistic regression models were developed for each marker in order to model composite adverse perinatal outcome as a function of the specific marker, planned delivery mode and the interaction between these two terms. In addition, multivariable logistic regression analysis with backward variable elimination was performed separately in each arm of the trial. The association between planned mode of delivery and composite adverse perinatal outcome, according to GA at delivery, was assessed using logistic regression analysis.ResultsOf the 2804 women initially randomized, 1391 were included in each study arm. None of the studied baseline markers was associated with a differential benefit of planned CD over planned VD in the rate of composite adverse perinatal outcome. GA at delivery was associated differentially with composite adverse perinatal outcome in the treatment arms (P for interaction < 0.001). Among pregnancies delivered at 32 + 0 to 36 + 6 weeks, there was a trend towards a lower rate of composite adverse perinatal outcome in those in the planned-VD group compared with those in planned-CD group (29 (2.2%) vs 48 (3.6%) cases; odds ratio (OR) 0.62 (95% CI, 0.37-1.03)). In pregnancies delivered at or after 37 + 0 weeks, planned VD was associated with a significantly higher rate of composite adverse perinatal outcome, as compared with planned CD (23 (1.5%) vs 10 (0.7%) cases; OR, 2.25 (95% CI, 1.06-4.77)).ConclusionThe perinatal outcome of twin pregnancies with the first twin in cephalic presentation may differ depending on GA at delivery and planned mode of delivery. At 32-37 weeks, planned VD seems to be favorable, while, from around 37 weeks onwards, planned CD might be safer. The absolute risks of adverse perinatal outcomes at term are low and must be weighed against the increased maternal risks associated with planned CD. © 2019 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

Project description:ObjectiveTo compare outcomes at 3 months post partum for women randomised to give birth by planned caesarean section (CS) or by planned vaginal birth (VB) in the Twin Birth Study (TBS).DesignWe invited women in the TBS to complete a 3-month follow-up questionnaire.SettingTwo thousand and eight hundred and four women from 25 countries.PopulationTwo thousand and five hundred and seventy women (92% response rate).MethodsWomen randomised between 13 December 2003 and 4 April 2011 in the TBS completed a questionnaire and outcomes were compared using an intention-to-treat approach.Main outcome and measuresBreastfeeding, quality of life, depression, fatigue and urinary incontinence.ResultsWe found no clinically important differences between groups in any outcome. In the planned CS versus planned VB groups, breastfeeding at any time after birth was reported by 84.4% versus 86.4% (P = 0.13); the mean physical and mental Short Form (36) Health Survey (SF-36) quality of life scores were 51.8 versus 51.6 (P = 0.65) and 46.7 versus 46.0 (P = 0.09), respectively; the mean Multidimensional Assessment of Fatigue score was 20.3 versus 20.8 (P = 0.14); the frequency of probable depression on the Edinburgh Postnatal Depression Scale was 14.0% versus 14.8% (P = 0.57); the rate of problematic urinary incontinence was 5.5% versus 6.4% (P = 0.31); and the mean Incontinence Impact Questionnaire-7 score was 20.5 versus 20.4 (P = 0.99). Partner relationships, including painful intercourse, were similar between the groups.ConclusionFor women with twin pregnancies randomised to planned CS compared with planned VB, outcomes at 3 months post partum did not differ. The mode of birth was not associated with problematic urinary incontinence or urinary incontinence that affected the quality of life. Contrary to previous studies, breastfeeding at 3 months was not increased with planned VB.Tweetable abstractPlanned mode of birth for twins doesn't affect maternal depression, wellbeing, incontinence or breastfeeding.

Project description:BackgroundVaginal delivery is a risk factor in pelvic floor disorders. We previously described changes in the pelvic floor associated with pregnancy and parturition in the squirrel monkey, a species with a humanlike pattern of spontaneous age- and parity-associated pelvic organ prolapse.ObjectiveThe potential to prevent or diminish these changes with scheduled cesarean delivery (CD) has not been evaluated. In a randomized, controlled trial, we compared female squirrel monkeys undergoing spontaneous vaginal delivery with those undergoing scheduled primary CD for pelvic floor muscle volumes, muscle contrast changes, and dynamic effects on bladder neck position.Study designLevator ani, obturator internus, and coccygeus (COC) muscle volumes and contrast uptake were assessed by magnetic resonance imaging in 20 nulliparous females examined prior to pregnancy, a few days after delivery, and 3 months postpartum. The position of bladder neck relative to bony reference line also was assessed with abdominal pressure using dynamic magnetic resonance imaging.ResultsBaseline measurements of 10 females randomly assigned to scheduled primary CD were not different from those of 10 females assigned to spontaneous vaginal delivery. Levator ani and obturator internus muscle volumes did not differ between groups, while volumes were reduced (P < .05) in the observation immediately after pregnancy. The COC muscles increased (P < .05) immediately after delivery for females in the spontaneous vaginal delivery group, but not for females in the scheduled CD group. Position of the bladder neck descended (P < .05) by 3 months postpartum in both groups.ConclusionScheduled CD diminishes changes in COC muscle volume and contrast reported to be associated with spontaneous vaginal delivery in squirrel monkeys. However, pelvic support of the bladder was not protected by this intervention suggesting that effects of pregnancy and delivery are not uniformly prevented by this procedure.

Project description:ObjectiveTo assess the impact of a web-based decision aid on patient-centered decision making outcomes among women considering a trial of labor after cesarean (TOLAC) versus planned repeat cesarean delivery.MethodsThe Birth Decision Aid Study (B-READY) was a quasi-experimental pre-post study of two sequential cohorts. From June 18, 2018 to July 31, 2019, 50 women were enrolled in routine care, followed by 50 women who were enrolled in the decision aid group. Inclusion criteria were singleton pregnancies between 19/0 to 36/6 weeks, ≤2 prior cesareans, and no contraindications to TOLAC. The decision aid group viewed the online Healthwise® "Pregnancy: Birth Options After Cesarean" program. Both groups received the same birth options counseling and completed the same online assessment. Primary patient-centered outcomes were knowledge about birth options and shared decision making at online assessment, and informed, patient-centered decision making about her preferred mode of delivery at delivery admission.ResultsAmong 100 women participated in this study (50 per group), the mean gestational age at enrollment was 31 weeks, and 71% or 63/89 women who consented to delivery data abstraction had a cesarean delivery. Women in the patient decision aid group gained more knowledge (defined as score ≥ 75%) about birth options compared to those in the routine care group (72% vs. 32%; adjusted odds ratio, AOR: 6.15 [95% CI: 2.34 to 16.14]), and were more likely to make an informed, patient-centered decision (60% vs. 26%; AOR: 3.30 [95% CI: 1.20 to 9.04]. Women in both groups reported similar involvement in shared decision making, as well as satisfaction and values. More than 90% of decision aid users reported it was a useful tool and would recommend it to other TOLAC-eligible women.ConclusionsA web-based birth options patient-centered decision aid for TOLAC eligible women can be integrated into prenatal Telehealth and may improve the quality of decision making about mode of delivery.Trial registrationThe study was registered with ClinincalTrials.gov and the ID# was NCT04053413 . Registered 12 August 2019 - Retrospectively registered.

Project description:IMPORTANCE:Planned cesarean delivery comprises a significant proportion of births globally, with combined rates of planned and unscheduled cesarean delivery in a number of regions approaching 50%. Observational studies have shown that offspring born by cesarean delivery are at increased risk of ill health in childhood, but these studies have been unable to adjust for some key confounding variables. Additionally, risk of death beyond the neonatal period has not yet been reported for offspring born by planned cesarean delivery. OBJECTIVE:To investigate the relationship between planned cesarean delivery and offspring health problems or death in childhood. DESIGN, SETTING, AND PARTICIPANTS:Population-based data-linkage study of 321,287 term singleton first-born offspring born in Scotland, United Kingdom, between 1993 and 2007, with follow-up until February 2015. EXPOSURES:Offspring born by planned cesarean delivery in a first pregnancy were compared with offspring born by unscheduled cesarean delivery and with offspring delivered vaginally. MAIN OUTCOMES AND MEASURES:The primary outcome was asthma requiring hospital admission; secondary outcomes were salbutamol inhaler prescription at age 5 years, obesity at age 5 years, inflammatory bowel disease, type 1 diabetes, cancer, and death. RESULTS:Compared with offspring born by unscheduled cesarean delivery (n?=?56,015 [17.4%]), those born by planned cesarean delivery (12,355 [3.8%]) were at no significantly different risk of asthma requiring hospital admission, salbutamol inhaler prescription at age 5 years, obesity at age 5 years, inflammatory bowel disease, cancer, or death but were at increased risk of type 1 diabetes (0.66% vs 0.44%; difference, 0.22% [95% CI, 0.13%-0.31%]; adjusted hazard ratio [HR], 1.35 [95% CI, 1.05-1.75]). In comparison with children born vaginally (n?=?252,917 [78.7%]), offspring born by planned cesarean delivery were at increased risk of asthma requiring hospital admission (3.73% vs 3.41%; difference, 0.32% [95% CI, 0.21%-0.42%]; adjusted HR, 1.22 [95% CI, 1.11-1.34]), salbutamol inhaler prescription at age 5 years (10.34% vs 9.62%; difference, 0.72% [95% CI, 0.36%-1.07%]; adjusted HR, 1.13 [95% CI, 1.01-1.26]), and death (0.40% vs 0.32%; difference, 0.08% [95% CI, 0.02%-1.00%]; adjusted HR, 1.41 [95% CI, 1.05-1.90]), whereas there were no significant differences in risk of obesity at age 5 years, inflammatory bowel disease, type 1 diabetes, or cancer. CONCLUSIONS AND RELEVANCE:Among offspring of women with first births in Scotland between 1993 and 2007, planned cesarean delivery compared with vaginal delivery (but not compared with unscheduled cesarean delivery) was associated with a small absolute increased risk of asthma requiring hospital admission, salbutamol inhaler prescription at age 5 years, and all-cause death by age 21 years. Further investigation is needed to understand whether the observed associations are causal.

Dataset Information

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

Publications

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

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