Oral Misoprostol Solution in Comparison to Vaginal Misoprostol in Induction of Labor
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- •Induction-delivery time
研究概览
简要总结
Induction of labour at term is a common obstetric intervention. Induction of labour is the artificial initiation of labour before its spontaneous onset for the purpose of delivery of the fetoplacental unit using mechanical or pharmacological methods.
To determine the effects of oral misoprostol solution compared to vaginal misoprostol in induction of labour.
详细描述
Patients recruited in the study will be primigravida at term with obstetric or medical indication for labour induction. These patients will be either booked attending antenatal clinic referred for induction of labour or emergency admissions in labour room.
A total of 100 women will be randomly selected for the study. I. Women will be given 20 ml (20 µg) of misoprostol solution orally every 2 hourly until adequate uterine contractions occurred (3 contractions per 10 min lasting 30-40 s).
II. The induction regimen included application of Vagiprost 25 µg tablet in the posterior fornix of the vagina every 4 h (up to 6 doses) after determination of the Bishop score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Primigravida or Primipara
- •Pregnancy between 36 and 42 weeks of gestation.
- •A live singleton fetus in cephalic presentation.
- •No history of uterine surgery.
- •Clinically adequate pelvis.
- •Modified Bishop's score <
- •Reactive Non stress test (NST) .
排除标准
- ••Known hypersensitivity or contraindications to oral misoprostol (uterine surgery).
- •Any antenatal medical complications.
- •A situation requiring LSCS (Maternal or Fetal) e.g:fetal distress
- •Non-reactive NST.
- •Patient's refusal to give consent
研究组 & 干预措施
oral
patients undergoing induction of labour using misoprostol oral solution
干预措施: Misoprostol (Drug)
vaginal
patients undergoing induction of labour using vaginal misoprostol
干预措施: Misoprostol (Drug)
结局指标
主要结局
•Induction-delivery time
时间窗: 2 hours
次要结局
未报告次要终点
研究者
Peter rafik helmy thabet
Clinical investigator
Ain Shams University