Labor Induction With Misoprostol Versus Oxytocin in Women With Premature Rupture of Membranes
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Vaginal delivery rate
研究概览
简要总结
This study compares the rate of vaginal delivery after induction of labor with misoprostol versus oxytocin in women with prelabor rupture of membranes. Participants will be randomized to receive either oral misoprotsol every four hours until going into labor, or intravenous oxytocin in increasing dose.
详细描述
Misoprostol is a synthetic prostaglandin analogue commonly used for labor induction. It causes uterine contractions and ripening of the cervix. Oxytocin sold under the brand name Pitocin among others, is a medication made from the peptide oxytocin and is used to cause contraction of the uterus to start labor.
This randomized controlled trial will compare induction of labor in women with term premature rupture of the membranes and unripe cervix using misoprostol versus oxytocin. The primary outcome is the rate of vaginal delivery. Secondary outcomes will include cesarean section rate, time interval from induction of labor to delivery, neonatal morbidity, patient satisfaction and side effects, as well as chorioamnionitis.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women in their 1st - 4th delivery
- •Term prelabor rupture of membranes (37+0 to 42+0 gestational age)
- •Vertex presentation
- •Singleton pregnancy
排除标准
- •Multiple pregnancy
- •Previous cesarean section
- •Chorioamnionitis on admission
- •>2 symptomatic uterine contractions in 10 minutes
- •Prostaglandins hypersensitivity
- •Contraindication for vaginal delivery
研究组 & 干预措施
misoprostol
misoprostol 50 mcg tablet by mouth every four hours for maximum dosage of six
干预措施: Misoprostol (Drug)
oxytocin
Oxytocin 10 IU in 1000 mL Standard solution. Starting with 10 mL/hr infusion rate and increasing by 10mL/hr every 20 minutes until achieving 3-5 regular uterine contractions every 10 minutes (as recorded by cardiotocography)
干预措施: Oxytocin (Drug)
结局指标
主要结局
Vaginal delivery rate
时间窗: During delivery
次要结局
- Operative delivery rate, Cesarean section rate, time interval from induction of labor to delivery(During delivery)
- chorioamnionitis rate(During or after delivery up to 7 days)
- Uterine tachysystole(During delivery)
- Neonatal morbidity(up to 7 days after delivery)
研究者
sammour.rami
Head of Obstetrics
Bnai Zion Medical Center