双胎妊娠计划性剖宫产与阴道分娩的随机对照试验。
A randomized trial of planned cesarean or vaginal delivery for twin pregnancy.
机构信息
Department of Obstetrics and Gynaecology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada.
出版信息
N Engl J Med. 2013 Oct 3;369(14):1295-305. doi: 10.1056/NEJMoa1214939.
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.).
背景
与单胎妊娠相比，双胎妊娠围产期不良结局的风险更高。对于双胎妊娠，计划剖宫产是否比计划阴道分娩的不良结局风险更低，目前尚不清楚。
方法
我们将孕龄 32 周 0 天至 38 周 6 天、第一胎为头位的双胎妊娠孕妇随机分为计划剖宫产组或计划阴道分娩组，只有出现剖宫产指征时才行剖宫产。选择性分娩计划在孕龄 37 周 5 天至 38 周 6 天之间进行。主要结局是胎儿或新生儿死亡或严重新生儿并发症的复合结局，以胎儿或婴儿为单位进行统计学比较。
结果
共有 1398 名妇女（2795 例胎儿）被随机分配到计划剖宫产组，1406 名妇女（2812 例胎儿）被随机分配到计划阴道分娩组。计划剖宫产组的剖宫产率为 90.7%，计划阴道分娩组为 43.8%。计划剖宫产组孕妇的分娩日期早于计划阴道分娩组（从随机分组到分娩的平均天数，12.4 天比 13.3 天；P=0.04）。计划剖宫产组与计划阴道分娩组的主要复合结局无显著差异（分别为 2.2%和 1.9%；计划剖宫产的优势比为 1.16；95%置信区间为 0.77 至 1.74；P=0.49）。
结论
在孕龄 32 周 0 天至 38 周 6 天、第一胎为头位的双胎妊娠中，与计划阴道分娩相比，计划剖宫产并不能显著降低或增加胎儿或新生儿死亡或严重新生儿并发症的风险。（由加拿大卫生研究院资助；ClinicalTrials.gov 编号，NCT00187369；当前对照试验编号，ISRCTN74420086。）
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