跳至主要内容
临床试验/NCT04705324
NCT04705324招募中不适用

Dilation and Curettage Versus Operative Hysteroscopy for Missed Abortion

Tel-Aviv Sourasky Medical Center2 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2022年1月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
55
试验地点
2
主要终点
Intrauterine adhesions (IUA)

研究概览

简要总结

Randomizedtrial comparing success and complication rates of operative hysteroscopy versus traditional dilation and curettage (D&C) in the management of first trimester missed abortion.

详细描述

A randomized controlled trial (RCT) of women diagnosed with first trimester spontaneous abortion. Participants interested in operative evacuation of the uterus will be randomized to either operative hysteroscopy or dilation an curettage (D&C). Study population will include pregnant women diagnosed with first trimester spontaneous abortion of up to 13+0 weeks from last menstrual period (LMP) or up to 11+0 weeks of gestation as determined by Crown-Rump Length (CRL). Women who will electively choose to terminate their pregnancy as well as women diagnosed with threatened, incomplete or inevitable abortion will be excluded. All participants will undergo diagnostic hysteroscopy 6-8 weeks after allocated treatment in order to rule out intrauterine adhesion formation and retained product of conception. The primary outcome measure is the risk of intrauterine adhesion formation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women diagnosed with missed abortion who choose to undergo surgical evacuation. and who are at gestational age of 5+0 weeks to 11+0 weeks from last menstrual period (LMP).

排除标准

  • women who electively choose to terminate pregnancy
  • women who took medical treatment for missed abortion prior to recruitment
  • women with known uterine abnormality

结局指标

主要结局

Intrauterine adhesions (IUA)

时间窗: 2 months

IUA formation will be assessed in all participants in the follow up diagnostic hysteroscopy performed 8 weeks after the primary treatment. IUA will be classified according to the American Society for Reproductive Medicine

次要结局

  • Retained product of conception (RPOC)(2 months)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Eli Sprecher, MD

Deputy Director Research & Development

Tel-Aviv Sourasky Medical Center

研究点 (2)

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