A Randomized Clinical Trial On Management Of Early Pregn

早期妊娠管理的随机临床试验

• 批准号: 6672653
• 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/6672653
• 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.

早期妊娠衰竭，包括自发流产，囊瘤妊娠和头三年胎儿死亡，发生在更多的临床认可的妊娠中。在半个多世纪的时间里，扩张和策展（D＆C）一直是早期妊娠失败的标准。最近，这个概念受到了挑战。几项前瞻性观察研究已经使用了堕胎不完整或错过的妇女中的米索前列醇。有效性率从56％到100％不等。但是，这些研究大多数很小。为了检查医疗管理与手术管理的疗效，安全性和可接受性，需要进行足够样本量的随机临床试验。我们计划在头三个月招募和随机将800例妊娠早期衰竭患者或800微克的阴道Misoprostol招募。经阴道超声将用于确定疏散的成功。