Vaginal Estradiol Pretreatment in Labour Induction With Misoprostol
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Time to cervical ripening.
研究概览
简要总结
To assess the effect of vaginal estradiol pretreatment before vaginal misoprostol on labor induction.
详细描述
A prospective double blind randomized clinical trial. Conducted at Ain Shams University Maternity Hospital. Patients fulfilling inclusion and exclusion criteria will be divided into two groups. Group (A):
100 patient will receive single dose vaginal estradiol 50mcg tablet (Ethinyl Estradiol manufactured by KAHIRA Pharmaceutical company) and vaginal misoprostol 25mcg tablet (Vagiprost manufactured by ADWIA Pharmaceutical company), misoprostol alone will repeated every 6hours up to five doses.
Group (B):
100 patients will receive placebo vaginally and misoprostol 25 mcg which will be repeated every 6 hours up to five doses.
Primary Outcome
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 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Estradiol + Misoprostol
100 patient will receive single dose vaginal estradiol 50mcg tablet (Ethinyl Estradiol manufactured by KAHIRA Pharmaceutical company) and vaginal misoprostol 25mcg tablet (Vagiprost manufactured by ADWIA Pharmaceutical company), misoprostol alone will repeated every 6hours up to five doses.
干预措施: Estradiol (Drug)
Estradiol + Misoprostol
100 patient will receive single dose vaginal estradiol 50mcg tablet (Ethinyl Estradiol manufactured by KAHIRA Pharmaceutical company) and vaginal misoprostol 25mcg tablet (Vagiprost manufactured by ADWIA Pharmaceutical company), misoprostol alone will repeated every 6hours up to five doses.
干预措施: Misoprostol (Drug)
Placebo + Misoprostol
100 patients will receive placebo vaginally and misoprostol 25 mcg which will be repeated every 6 hours up to five doses.
干预措施: Placebo (Drug)
Placebo + Misoprostol
100 patients will receive placebo vaginally and misoprostol 25 mcg which will be repeated every 6 hours up to five doses.
干预措施: Misoprostol (Drug)
结局指标
主要结局
Time to cervical ripening.
时间窗: 24 hours
次要结局
- Time to active labor(30 hours)
- Number of misoprostol doses(24 hours)
- Induction delivery time(48 hours)
研究者
Mohamed S Sweed, MD
Mohamed S. Sweed lecturer of Obstetrics & Gynecology AinShams University.
Ain Shams University