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临床试验/NCT03584698
NCT03584698已完成4 期

The Effect of Adding Vaginal Evening Primrose Oil to Misoprostol During Induction of Second-trimester Missed Miscarriage; a Randomized Controlled Trial

Assiut University1 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2019年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
144
试验地点
1
主要终点
The induction to fetal expulsion time.

研究概览

简要总结

Termination of pregnancy is an important subject that has complex and emotional controversies. The most common time of termination of pregnancy is the mid-trimester which has two-thirds of all serious abortion-related complications. There are many indications for mid trimester termination of pregnancy such as missed abortion, serious fetal abnormalities and lastly some women do not wish to continue a pregnancy and will often request termination of pregnancy

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
Single (Participant)

入排标准

性别
Female
接受健康志愿者

入选标准

  • Nullipara or previous vaginal delivery only
  • Bishop score was ≤ 5
  • Women who will accept to participate in the study

排除标准

  • Multiple gestations
  • Rupture of fetal membranes
  • Previous cesarean sections
  • Women with heavy bleeding
  • Evidence of low implanted placenta by US
  • Evidence of intra-uterine infection (either clinical or laboratory)

研究组 & 干预措施

study group

Experimental

Misoprostol + Evening primrose oil group

干预措施: Misoprostol 100Mcg Tab (Drug)

study group

Experimental

Misoprostol + Evening primrose oil group

干预措施: Evening Primrose Oil 1000 MG (Drug)

control group

Active Comparator

Misoprostol only group

干预措施: Misoprostol 100Mcg Tab (Drug)

结局指标

主要结局

The induction to fetal expulsion time.

时间窗: 24 hours

Duration of delivery of fetus

次要结局

未报告次要终点

研究者

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

Ahmed Mohamed Abbas

Principal investigator

Assiut University

研究点 (1)

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