Vaginal Dinoprostone Versus Vaginal Misoprostol for Induction of Labour in Post-dated Pregnancy; a Randomized Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 370
- 试验地点
- 1
- 主要终点
- Sucess of induction
研究概览
简要总结
This randomized controlled study was carried out on 370 pregnant women with gestational age ≥ 40 weeks of different ages and parities at El-Shatby Maternity University Hospital after approval of ethical committee of Alexandria Faculty of Medicine. After assessment for eligibility & enrollment in the study, women were randomly assigned into one of the two study groups, Group (I) received 3 mg vaginal Dinoprostone of maximum 2 doses 6 hours apart and Group (II) received 50 μg of vaginal misoprostol of maximum 2 doses 6 hours apart.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pregnant women at 40 weeks or beyond
- •singleton pregnancy
- •Bishop score 4 or more
- •fetus in a cephalic presentation
- •Adequate fetal biophysical profile
排除标准
- •Any signs of labour (Prelabor rupture of membranes)
- •Grand Multiparous women (parity of 4 or more)
- •fetal weight > 4 kg
- •BMI > 35
研究组 & 干预措施
Vaginal Dinoprostone
received 3 mg vaginal Dinoprostone of maximum 2 doses 6 hours apart.
干预措施: Vaginal Dinoprostone (Drug)
Vaginal Misoprostol
received 50μg of vaginal misoprostol of maximum 2 doses 6 hours apart.
干预措施: Vaginal Dinoprostone (Drug)
结局指标
主要结局
Sucess of induction
时间窗: number of women who delivered vaginally after induction
percentage of women with a successful vaginal delivery
Induction to delivery time
时间窗: time from start of induction till delivery of the fetus
time lapse from receiving first dose of induction till delivery of the fetus
次要结局
- Postpartum hemorrhage(after delivery of the placenta)
- neonatal outcomes(at 1 and 5 minutes of delivery)
研究者
Mervat Sheikhelarab Elsedeek Ibrahim Omran
Professor of Obstetrics and Gynaecology
University of Alexandria