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临床试验/NCT02485444
NCT02485444已完成4 期

Oxytocin Infusion vs. Spontaneous Follow-up for Third-stage Management After Second-trimester Abortion: A Randomized Clinical Trial

Ataturk University1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2015年6月8日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
160
试验地点
1
主要终点
Complete abortion rate

研究概览

简要总结

This study compares oxytocin infusion to spontaneous follow-up for third-stage of labor at induced mid-trimester abortions. Patients will be randomized to oxytocin infusion or observation with no pharmacologic intervention. Primary outcome of the study is complete abortion rate within two hours of fetal delivery.

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
17 Years 至 45 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Women who had mid-trimester termination of pregnancy between 13-24 gestational weeks

排除标准

  • If fetus and placenta expelled together
  • Obstetrical haemorrhage needs intervention
  • Known prostaglandin allergy

研究组 & 干预措施

Oxytocin

Active Comparator

干预措施: Oxytocin (Drug)

结局指标

主要结局

Complete abortion rate

时间窗: within 5 minute after placenta delivered

expulsion of placenta completely without an instrumental assistance within two hours after delivery of fetus

次要结局

  • Blood loss estimated by gravimetric method(within 10 minutes after delivery of placenta)
  • Transfusion rate(Within 7 days of hospitalization)
  • Change in hemoglobin measured by difference in hemoglobin before and 24-hour after abortion(24 hours after delivery of placenta)
  • Placenta delivery time measured by time elapsed until the delivery of the placenta from the delivery of foetus(5 minute after delivery of placenta)

研究者

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

Ragıp Atakan Al

professor

Ataturk University

研究点 (1)

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