A Randomized Clinical Trial On Early Pregnancy Failure

背景：米索前列醇用于早期妊娠失败的药物治疗已越来越多地被使用。然而，这种治疗的有效性、安全性和可接受性尚未在大型随机试验中确定。 方法：这项多中心试验随机选择652名早孕失败(无胚胎妊娠、胎儿死亡、不完全和不可避免的自然流产)的妇女，按1：3的比例接受真空吸引术(VA，护理标准)或800 g米索前列醇。接受米索前列醇的受试者在第3天返回。如果POC排出不完全，则第二次给药800g米索前列醇。在第8天，如果驱逐仍未完成，退伍军人管理局将提供退伍军人管理局。第15天，所有受试者均返回进行随访。在第30天进行了一次电话采访。失败被定义为在最初治疗后30天内因任何原因再次呼吸(对于米索前列醇治疗组)或再次呼吸(对于VA组)。这项研究的目的是测试米索前列醇组的成功率是否比VA组低18%。如果两组的成功率差异不超过18%，治疗将被认为是相等的。 结果：总体而言，分别有491名和161名女性被随机分为内科或外科治疗。两组的基线特征具有可比性。在米索前列醇组，71%的妇女在第3天完全排出，85%的妇女在第8天完全排出。总体而言，VA组和米索前列醇组的治疗失败的发生率分别为3%和15%(差异=12%，90%可信区间9，16%)。需要住院的出血或子宫内膜炎很少见(1%)，两组之间没有差异。在接受内科和外科治疗的妇女中，治疗后急诊就诊的比例分别为3.1%和2.0%(p=0.59)。78%的女性会再次选择米索前列醇，83%的女性会在需要时向其他人推荐。可接受性与VA组无差异。 结论：米索前列醇800 mg阴道给药治疗早孕失败安全有效，成功率在85%左右。出血和子宫内膜炎的风险非常低，副作用是可以容忍的。这是大多数参与者可以接受的治疗方法。

Background: Medical management with misoprostol for early pregnancy failure has been increasingly used. However, the efficacy, safety and acceptability of this treatment have yet to be established in a large randomized trial. Methods: This multicenter trial randomized 652 women with a first trimester pregnancy failure (anembryonic gestation, fetal demise, incomplete and inevitable spontaneous abortion) to receive either vacuum aspiration (VA, standard of care) or 800 ig vaginal misoprostol in a 1:3 ratio. Subjects receiving misoprostol returned on Day 3. If the expulsion of POC was incomplete, a second dose of 800 ig vaginal misoprostol was given. On Day 8, if the expulsion was still incomplete, VA was offered. On Day 15, all subjects returned for follow-up visit. A telephone interview was conducted on Day 30. Failure was defined as VA (for the misoprostol treatment group) or reaspiration (for the VA group) for any reason within 30 days after the initial treatment. The study was powered to test whether the success rate in the misoprostol group was lower than that in the VA group by 18%. If the difference in success rate between the two groups did not exceed 18%, the treatments would be considered equivalent. Results: Overall, 491 and 161 women, respectively, were randomized to medical or surgical management. Baseline characteristics of the two groups were comparable. In the misoprostol group, 71% of women had complete expulsion by day 3 and 85% by day 8. Overall, treatment failures occurred in 3% of the VA group and 15% of the misoprostol group (difference = 12%, 90% CI 9, 16%). Hemorrhage or endometritis that required hospitalization was rare (< 1%) and there were no differences between the two groups. Emergency hospital visit after the treatment occurred to 3.1% and 2.0% of women who received medical and surgical treatment, respectively (p = 0.59). 78% of women would choose misoprostol again and 83% recommend to others if needed. The acceptability was not different from that in the VA group. Conclusion: Treatment of early pregnancy failure with 800 mg misoprostol per vagina is efficacious and safe with a success rate of around 85%. The risks for hemorrhage and endometritis are very low, and the side-effects are tolerable. It is an acceptable treatment to the majority of the participants.