A Comparison of the Efficacy and Safety of Repetitive Hourly Dose of Oral Misoprostol and Two Hourly Dose Oral Regimens for Cervical Ripening and Labor Induction
试验速览
- 阶段
- 2 期
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Mode of delivery
研究概览
简要总结
This study compares safety and efficacy between repetitive hourly dose of oral misoprostol and two hourly dose oral regimens for cervical ripening and labor induction.
详细描述
Misoprostol is an effective agent for the induction of labor.existing guidelines recommend oral misoprostol solution every two hours.However,more research is required to optimize the use of oral misoprostol solution for labor induction.The current study is to compare efficacy and safety of repetitive hourly dose of oral misoprostol solution with two hourly dose of oral misoprostol solution for cervical ripening and labor induction.
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
- Double (Participant, Investigator)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Nulliparas
- •Term pregnancy(equal or more than 37 wks)
- •Bishop score <6
- •Cephalic presentation
- •reassuring fetal heart rate pattern
- •Not in labor ( no uterine contractions)
- •Clinically adequate pelvis
- •Singleton live pregnancy
排除标准
- •Allergic to misoprostol or prostaglandin analogues
- •Previous uterine scar( cesarean section,hysterotomy,myomectomy)
- •Multiple fetal gestations
- •Fetal demise
- •Preterm labor
- •Malpresentations
- •Non reactive cardiotocography at admission
- •Cephalo pelvic disproportion
- •Fetal macrosomia
研究组 & 干预措施
repetitive hourly dose of oral misoprostol
The dose will be 10 microgram oral misoprostol that will be administered hourly up to 12 doses or till onset of regular uterine activity.
干预措施: Misoprostol (Drug)
two hourly dose of oral misoprostol
The dose will be 20 microgram oral misoprostol solution that will be administered every 2 hours up to 6 doses or till onset of regular uterine activity.
干预措施: Misoprostol (Drug)
结局指标
主要结局
Mode of delivery
时间窗: 24 hours from the first dose of induction till delivery
Successful vaginal delivery within 24 hours from starting induction of labor or cesarean section delivery after failed trial of induction.
次要结局
- Adverse neonatal outcomes(24 hours post partum)
- Adverse maternal outcomes(in 24 hours)
研究者
Esam salah mohamed hagag
Director,clinical research
Ain Shams University