A Randomized Clinical Trial On Early Pregnancy Failure

关于早期妊娠失败的随机临床试验

• 批准号: 7208944
• 负责人: JIM ZHANG
• 金额: --
• 依托单位: EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/7208944
• 关键词: abortifacients; clinical trials; drug screening /evaluation; embryo /fetus death; female; female reproductive system surgery; hemorrhage; human subject; human therapy evaluation; interview; oxytocics; patient oriented research; prostaglandin E; prostaglandin analogs; satisfaction; spontaneous abortion; women' s health

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.

背景：越来越多地使用了米索前列醇的医疗管理。但是，在大型随机试验中尚未确定这种治疗方法的功效，安全性和可接受性。 方法：这项多中心试验随机652名孕妇妊娠失败的妇女（厌食症妊娠，胎儿灭绝，不完全和不可避免的自发流产）以1：3的比例接受真空吸入（VA，护理标准）或800 Ig阴道默Misoprostol。接受米索前列醇的受试者在第3天返回。如果POC的驱逐不完整，则给出了800次Ig阴道米索前列醇的第二剂。在第8天，如果驱逐出境仍然不完整，则提供了VA。在第15天，所有受试者都返回进行后续访问。在第30天进行了电话访谈。在初次治疗后30天内，由于任何原因而将失败定义为VA（米索前列醇治疗组）或重新访问（对于VA组）。该研究有动力测试米索前列醇组的成功率是否低于VA组的成功率。如果两组之间的成功率差异不超过18％，则将视为等效。 结果：总体而言，分别为491名和161名女性，随机分配给医学或外科管理。两组的基线特征是可比的。在米索前列醇组中，有71％的妇女在第3天到第8天都完全被驱逐出境。总体而言，VA组的3％发生了治疗失败，米索前列醇组的15％发生（差异= 12％，90％CI 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。治疗后的紧急医院就诊分别为3.1％和2.0％接受医疗和手术治疗的妇女（p = 0.59）。 78％的妇女会再次选择米索前列醇，如果需要，有83％的妇女向他人推荐。可接受性与VA组中的可接受性没有什么不同。 结论：每个阴道用800 mg米索前列醇治疗早期妊娠衰竭是有效且安全的，成功率约为85％。出血和子宫内膜炎的风险非常低，并且副作用是可以忍受的。这是对大多数参与者的可接受治疗方法。