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Clinical Trial On Management Of Pregnancy Failure

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:
$0.0万
依托单位国家:
美国
项目类别:
财政年份:
--
资助国家:
美国
项目状态:
未结题
起止时间:
至

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中文摘要
翻译
超过15%的临床确认妊娠会发生早期妊娠失败,包括自然流产、无胚胎妊娠和早期妊娠胎儿死亡。半个多世纪以来,扩张和刮宫(D&C)一直是早期妊娠失败的标准护理。最近,这一观点受到了挑战。几项前瞻性观察研究已经将米索前列醇用于流产不全或遗漏的妇女。有效率为56%~100%。然而,这些研究中的大多数都是相当小的。为了检验内科治疗与外科治疗的有效性、安全性和可接受性,需要一项具有足够样本量的随机临床试验。我们计划招募800名妊娠早期失败的患者,并将其随机分为服用D&C或阴道米索前列醇800微克的患者。经阴道超声将被用来确定排出成功与否。
英文摘要
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.
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