Is More Than One Dose of Misoprostol Needed to Expedite Vaginal Delivery in a Patient With an Unripe Cervix?
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 243
- 主要终点
- Number of Participants With Vaginal Delivery Within 24 Hours
研究概览
简要总结
The goal of this study is to determine whether inducing labor with just one dose of misoprostol, followed by treatment with oxytocin, will still be effective enough to increase the chances of having a successful vaginal delivery as compared to using more than one dose of misoprostol, followed by treatment with oxytocin.
详细描述
This study involves a comparison of two different regimens of prostaglandin use for "cervical ripening" prior to induction of labor. Women admitted to the hospital for induction of labor who are found to have "unripe" cervixes at the time of admission, and who agree to participate in the study will be randomly assigned to one of two treatment groups. In one group, a single dose of 25 µcg of misoprostol will be administered vaginally and four hours later oxytocin induction will be started if clinically indicated. In the second group of women, repeat doses of misoprostol will be given every four hours up to six doses unless labor or cervical ripening occurs sooner. At this point, oxytocin will be started as needed. Success of vaginal delivery by 24 hours, time from initiation of protocol to delivery and cesarean section rates will be compared. Complications such as postpartum hemorrhage, episodes of tachysystole with fetal compromise and chorioamnionitis and endometritis will be monitored.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Any pregnant woman undergoing induction of labor
- •Live singleton pregnancy ≥ 37 week gestation
- •Bishop score < 6
- •Category I fetal heart rate
排除标准
- •Contraindications to vaginal delivery (e.g. vasa previa, placenta prevue,non-vertex presentation, umbilical cord prolapse, and active genital herpes infection.)
- •Pregnancies complicated by major fetal anomalies
- •Any contraindication to the use of misoprostol, including
- •History of previous c-section or major uterine surgery
- •Prior allergic reaction
- •Category II or III fetal heart rate
- •Regular uterine contractions ≥ 3 in a 10-minute period persistent for at least 30 minutes
- •Estimated fetal weight < 10 percentile
- •Premature rupture of membranes
- •Age < 18 years old
- •Women who do not have the capacity to consent
研究组 & 干预措施
Single Dose
single dose of misoprostol
干预措施: Misoprostol (Drug)
Multiple Dose
multiple doses of misoprostol
干预措施: Misoprostol (Drug)
结局指标
主要结局
Number of Participants With Vaginal Delivery Within 24 Hours
时间窗: within 24 hours
To compare the rate of vaginal delivery within 24 hours in patients who receive a single dose of misoprostol versus those receiving multiple doses of this medication.
次要结局
- To Determine the Interval From Initiation of Misoprostol to Delivery in Each Group(within 24 hours from the initial intervention)
研究者
Peter S. Bernstein
Prof., Maternal Fetal Medicine
Montefiore Medical Center