Mei-Dan Elad, Asztalos Elizabeth V, Willan Andrew R, Barrett Jon F R
Women and Babies Program, Sunnybrook Health Sciences Center, Sunnybrook Research Institute, 2075 Bayview Ave, Toronto, ON, M4N 3M5, Canada.
Child Health Evaluative Sciences, SickKids Research Institute, University of Toronto, The Hospital for Sick Children, 555 University Avenue, Toronto, M5G 1X8, ON, Canada.
BMC Pregnancy Childbirth. 2017 Jan 6;17(1):9. doi: 10.1186/s12884-016-1201-8.
This secondary analysis for the Twin Birth Study, an international, multicenter trial, aimed to compare the cesarean section rates and safety between methods of induction of labor in twin pregnancies.
Women with twin pregnancies where the first twin was in a cephalic presentation and who presented for labor induction, were non-randomly assigned to receive prostaglandin or amniotomy and/or oxytocin. Main outcome measures were the rates of unplanned cesarean section and neonatal and maternal mortality or serious morbidity.
153 (41.5%) were induced by prostaglandin (prostaglandin group) and 215 (58.5%) were induced by amniotomy and/or oxytocin alone (no prostaglandin group). Induction using prostaglandin was more common in countries with a low perinatal mortality rate <10/1000 (45.7 versus 32.5%, p = 0.02). Cesarean section rates were similar in the two groups: 62/153 (40.5%) in the prostaglandin group and 87/215 (40.5%) in the no prostaglandin group (odds ratio 1, 95% CI 0.65-1.5). Nulliparity, late maternal age, non-cephalic presentation of twin B and high country's perinatal mortality rate were found to be independently associated with the induction to end with an unplanned cesarean section. There were no significant differences between groups with respect to maternal or neonatal adverse outcomes.
The need for cervical ripening by prostaglandin had no effect on the incidence of cesarean delivery or an abnormal outcome. There is a significant risk of unplanned cesarean section independent of chosen induction method.
This trial was registered at the International Standard Randomized Controlled Trial Register (identifier ISRCTN74420086 ; December 9, 2003) and retrospectively registered at the www.clinicaltrials.gov (identifier NCT 00187369 ; September 12, 2005).
本研究是对一项国际多中心试验——双胎分娩研究的二次分析,旨在比较双胎妊娠引产方法之间的剖宫产率及安全性。
双胎妊娠且第一胎儿为头先露、前来引产的妇女,被非随机分配接受前列腺素或人工破膜和/或缩宫素。主要结局指标为非计划剖宫产率、新生儿及孕产妇死亡率或严重发病率。
153例(41.5%)采用前列腺素引产(前列腺素组),215例(58.5%)仅采用人工破膜和/或缩宫素引产(非前列腺素组)。在围产期死亡率<10/1000的低死亡率国家,使用前列腺素引产更为常见(45.7%对32.5%,p = 0.02)。两组的剖宫产率相似:前列腺素组为62/153(40.5%),非前列腺素组为87/215(40.5%)(比值比1,95%可信区间0.65 - 1.5)。发现初产妇、产妇年龄较大、双胎B非头先露以及国家围产期死亡率较高与引产最终导致非计划剖宫产独立相关。两组在孕产妇或新生儿不良结局方面无显著差异。
前列腺素促宫颈成熟的需求对剖宫产发生率或异常结局无影响。无论选择何种引产方法,非计划剖宫产均存在显著风险。
本试验在国际标准随机对照试验注册库(标识符ISRCTN74420086;2003年12月9日)注册,并于www.clinicaltrials.gov(标识符NCT 00187369;2005年9月12日)进行回顾性注册。