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临床试验/NCT04602052
NCT04602052已完成不适用

Comparison of Surgical Versus Medical Termination of Pregnancy Between 13-20 Weeks of Gestation in Ethiopia: A Quasi-experimental Study.

St. Paul's Hospital Millennium Medical College, Ethiopia2 个研究点 分布在 1 个国家目标入组 279 人开始时间: 2018年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
279
试验地点
2
主要终点
Composite complication rate

研究概览

简要总结

The purpose of the study is to determine the safety and effectiveness of dilation and evacuation for surgical abortion as compared to medical abortion

详细描述

All patients with a gestational age between 13-20 weeks are fully counseled on the risks and benefits and given the option of medical or surgical abortion. Those who choose medical abortion receive mifepristone 200 mg on day 1 and are appointed to return to SPHMMC 24-48 hours later for admission and misoprostol administration. Those who chose surgical abortion are given mifepristone 200 mg with or without laminaria and appointed to return the next day for surgical abortion.

研究设计

研究类型
Interventional
分配方式
Non 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 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Gestational age between 13 - 20 weeks confirmed with ultrasound,
  • Age at or more than18 years,
  • Having a working phone and willingness to be contacted for a follow-up questionnaire 2 weeks after the procedure.

排除标准

  • Inability to give consent
  • complicated abortion (missed abortion, septic abortion)

结局指标

主要结局

Composite complication rate

时间窗: During the abortion procedure and within 2 weeks post procedure

Presence of one of the following complications: bleeding requiring observation, genital tract lacerations requiring repair, need for additional intervention to complete the abortion procedure, and one or more symptoms of pelvic infection

次要结局

  • Other serious maternal complications(During the abortion procedure and within 2 weeks post procedure)

研究者

发起方
St. Paul's Hospital Millennium Medical College, Ethiopia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tesfaye H. Tufa, MD

Assistant Professor of Obstetrics and Gynecology

St. Paul's Hospital Millennium Medical College, Ethiopia

研究点 (2)

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