PROMMO Trial: Prelabor Rupture of Membranes Managed With Oral Misoprostol Versus Intravenous Oxytocin
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Primary Endpoint: Time from initial medication administration to vaginal delivery
研究概览
简要总结
This is a prospective, randomized trial looking at the ideal method of labor induction for women with prelabor rupture of membranes and an unfavorable cervical Bishop score. The study will compare oral misoprostol and intravenous oxytocin.
详细描述
The purpose of this study is to look at optimal induction management of prelabor rupture of membranes (PROM) at or beyond 34 weeks gestational age.
Objective 1: To determine if there is a decrease in time from initiation of induction of labor to vaginal delivery in women with an unfavorable cervix with the use of oral misoprostol versus intravenous oxytocin.
Hypothesis: Cervical ripening with misoprostol will be beneficial in women with an unfavorable cervix.
Sub objective 1: To determine if the use of oral misoprostol for cervical ripening decreases the rate of postpartum hemorrhage in women with PROM.
Hypothesis: Misoprostol use will result in significantly lower rate of postpartum hemorrhage.
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
- •Early Term to late term pregnancy (>37 weeks and 0 days and <42 weeks and 0 days)
- •Late Preterm Pregnancy (34 weeks and 0 days and <37 weeks)
- •Confirmed rupture of membranes by either sterile speculum exam or AmniSure
- •Simplified Bishop Score ≤ 6
- •Maternal Age > 18 years old
- •Singleton gestation
- •Appropriate gestational age dating by certain LMP or ultrasound performed prior to 20 weeks gestational age
排除标准
- •Concern for intra-amniotic infection
- •Previous Cesarean delivery
- •Lack of appropriate dating criteria for the pregnancy
- •Inability to give informed consent in the patient's native language
- •Known bleeding disorder such as von Willebrand's disease or hemophilia
- •Anticoagulation administration within 24 hours of delivery
研究组 & 干预措施
oral misoprostol
At time of delivery, participants randomly assigned to either oral misoprostol will receive 50 mcg of Misoprostol every 4 hours up to 6 doses, OR until simplified Bishop score >6 (whichever is achieved first).
干预措施: Misoprostol Oral Product (Drug)
intravenous oxytocin
At time of delivery, participants randomly assigned to intravenous oxytocin, will be administered the drug per standard of labor and delivery titrations.
干预措施: Intravenous Oxytocin (Drug)
结局指标
主要结局
Primary Endpoint: Time from initial medication administration to vaginal delivery
时间窗: Up to 72 hours
time from initiation of induction of labor to vaginal delivery in women with an unfavorable cervix with the use of oral misoprostol versus intravenous oxytocin
次要结局
- Secondary endpoint 2: Rate of Suspected or Confirmed Intrapartum Intramniotic Infection(Prior to delivery)
- Secondary endpoint 3: Rate of Suspected Endometritis(From delivery to 6 weeks postpartum)
- Secondary endpoint 1: Rate of Postpartum Hemorrhage(up to 24 hours for immediate postpartum hemorrhage)
- Secondary endpoint 4: Rate of Infectious Morbidity for Neonates(up to 6 weeks of life)
- Secondary endpoint 5: Participant Satisfaction as Measured by modified Labour Agentry Scale(Postpartum day one with repeat instrument at 6 weeks postpartum)