Allanson Emma R, Copson Sean, Spilsbury Katrina, Criddle Sonya, Jennings Belinda, Doherty Dorota A, Wong Antonia M, Dickinson Jan E
Division of Obstetrics and Gynaecology, University of Western Australia, Perth, the Institute for Health Research, University of Notre Dame, Fremantle, King Edward Memorial Hospital, Perth, Western Australia, and the Office of the Chief Nurse and Midwife, Department of Health, Northern Territory Government, Darwin, Northern Territory, Australia.
Obstet Gynecol. 2021 May 1;137(5):801-809. doi: 10.1097/AOG.0000000000004344.
To assess the efficacy of pretreatment with mifepristone before misoprostol, compared with misoprostol alone, for termination of pregnancy after a fetal death in the second trimester.
This prospective, double blind, placebo-controlled trial randomized women requiring a termination of pregnancy after fetal death between 14 and 28 weeks of gestation to placebo or 200 mg mifepristone orally 24-48 hours before the termination of pregnancy with misoprostol (400 micrograms every 6 hours vaginally for women at 24 weeks of gestation or less, and 200 micrograms every 4 hours vaginally for women at 24 weeks of gestation or more). Based on a median labor with misoprostol alone in the second trimester of 13 hours, a sample size of 116 women per group was planned to compare the primary outcome of time from administration of misoprostol to delivery. The trial was ceased after 66 women were enrolled secondary to prolonged time to achieve recruitment.
From April 2013 to November 2016, 66 women were randomized (34 to placebo and 32 to mifepristone). There were no differences in the characteristics between the two groups. The median time for the primary outcome of administration of misoprostol to delivery in the placebo group was 10.5 hours, compared with 6.8 hours in the treatment group (hazard ratio 2.41 95% CI 1.39-4.17, P=.002). Women in the placebo group required more doses of misoprostol (3.4 vs 2.1, P=.002) and more misoprostol overall (1,181.8 micrograms, vs 767.7 micrograms, P=.003). There was no difference in maternal complications between the two groups. Women in the mifepristone group reported improved perception of the procedure.
The sequential use of mifepristone and misoprostol for the termination of pregnancy after fetal deaths between 14 and 28 weeks of gestation reduces the time to delivery, compared with the use of misoprostol alone, with no worsening of maternal complications.
Australian New Zealand Clinical Trials Registry, ACTRN12612000884808.
评估米非司酮在米索前列醇之前预处理与单独使用米索前列醇相比，用于中期妊娠胎儿死亡后终止妊娠的疗效。
这项前瞻性、双盲、安慰剂对照试验将妊娠14至28周胎儿死亡后需要终止妊娠的妇女随机分为安慰剂组或在使用米索前列醇（妊娠24周及以下的妇女每6小时阴道给予400微克，妊娠24周以上的妇女每4小时阴道给予200微克）终止妊娠前24 - 48小时口服200毫克米非司酮组。基于中期妊娠单独使用米索前列醇引产的中位时间为13小时，计划每组纳入116名妇女以比较米索前列醇给药至分娩时间这一主要结局。在招募了66名妇女后，由于招募时间延长，试验停止。
从2013年4月至2016年11月，66名妇女被随机分组（34名进入安慰剂组，32名进入米非司酮组）。两组之间的特征无差异。安慰剂组米索前列醇给药至分娩这一主要结局的中位时间为10.5小时，而治疗组为6.8小时（风险比2.41，95%可信区间1.39 - 4.17，P = 0.002）。安慰剂组的妇女需要更多剂量的米索前列醇（3.4剂对2.1剂，P = 0.002）且总体使用的米索前列醇更多（1181.8微克对767.7微克，P = 0.003）。两组之间的母体并发症无差异。米非司酮组的妇女对该操作的感受有所改善。
与单独使用米索前列醇相比，妊娠14至28周胎儿死亡后序贯使用米非司酮和米索前列醇终止妊娠可缩短分娩时间，且母体并发症未加重。
澳大利亚新西兰临床试验注册中心，ACTRN12612000884808。
