Clinical Trial On Management Of Pregnancy Failure

妊娠失败管理的临床试验

• 批准号: 6541327
• 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/6541327
• 关键词: clinical trials; female; female reproductive system surgery; human subject; human therapy evaluation; patient care management; patient oriented research; pregnancy disorder; pregnancy disorder chemotherapy; pregnancy loss; prostaglandin E; women's health

Early pregnancy failure, including spontaneous abortion, anembryonic gestation and first trimester fetal death, occurs in more that 15% of clinically recognized pregnancies. For more than half a century, dilatation and curettage (D&C) has been a standard of care for early pregnancy failure. Recently, this notion has been challenged. Several prospective observational studies have used misoprostol in women with incomplete or missed abortions. The effectiveness rate ranged from 56% to 100%. However, most of these studies were quite small. To examine the efficacy, safety and acceptability of medical management versus surgical management, a randomized clinical trial with an adequate sample size is needed. We plan to recruit and randomize 800 patients with an early pregnancy failure in the first trimester to eith D&C or vaginal misoprostol of 800 micrograms. Transvaginal ultrasound will be used to determine the success of evacuation.

早期妊娠失败，包括自然流产、无胚胎妊娠和妊娠头三个月胎儿死亡，在临床确认的妊娠中发生的比例超过15%。半个多世纪以来，扩张和刮宫术（D&C）一直是早期妊娠失败的标准治疗方法。最近，这一观念受到了挑战。几项前瞻性观察性研究已将米索前列醇用于不完全流产或未流产的妇女。有效率从56%到100%不等。然而，这些研究大多规模很小。为了检验药物治疗与手术治疗的有效性、安全性和可接受性，需要进行足够样本量的随机临床试验。我们计划招募并随机分配800名妊娠早期失败的患者，使用D&C或阴道米索前列醇800微克。阴道超声将用于确定是否成功撤离。