Efficacy of Intravaginal Administration of Isosorbide Mononitrate Together With Misoprostol Versus Misoprostol Alone in Induction of Labor in Postdate Women
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The duration of induction to active phase interval
研究概览
简要总结
We will compare between using isosorbide mononitrate together with misoprostol versus the misoprostol alone in induction of labor in postdate women
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •age (20-35 yrs)
- •single fetus
- •gestational age > 40weeks
- •not in labor
- •bishop score < 7
- •no medical disorder
排除标准
- •Gestational age ≤40 weeks
- •patient with a ripe cervix
- •rupture of membranes
- •suspected chorioamnionitis
- •placenta previa
- •history of major uterine surgery
- •hypertonic uterine pattern
- •contraindicated to receive PG
- •fetal malpresentation
- •multiple pregnancy
- •intrauterine growth retardation
- •women with any general medical disorder
研究组 & 干预措施
Misoprostol alone
Enrolled women will receive 25 πg of misoprostol which will be placed intravaginally 4 hourly, maximum up to 5 doses
干预措施: Misoprostol (Drug)
Isosorbide mononitrate with misoprostol
Enrolled women will receive 25 πg of misoprostol together with 40 mg isosorbide mononitrate which will be placed intravaginally 4 hourly, maximum up to 5 doses
干预措施: Isosorbide mononitrate (Drug)
Isosorbide mononitrate with misoprostol
Enrolled women will receive 25 πg of misoprostol together with 40 mg isosorbide mononitrate which will be placed intravaginally 4 hourly, maximum up to 5 doses
干预措施: Misoprostol (Drug)
结局指标
主要结局
The duration of induction to active phase interval
时间窗: 12 weeks
Measure the time between the beginning of the induction to enter the active phase of labor
次要结局
未报告次要终点
研究者
Abdelrahman Ali Fadel Youssef Mohamed
Principal investigator
Ain Shams University