Randomized Comparison of Vaginal Misoprostol and Intravenous Oxytocin for Labor Induction in Multiparous Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 主要终点
- Time From Induction to Vaginal Delivery
研究概览
简要总结
This study will compare the effectiveness of vaginal misoprostol (Cytotec) and intravenous oxytocin (Pitocin) in multiparous women who present at term for labor induction.
详细描述
Both oxytocin and misoprostol have been demonstrated to be safe and effective methods for induction of labor. A direct comparison of efficacy and time to delivery in multiparas has not been specifically investigated. Additionally, the study will look at costs of the two drugs.Oxytocin is administered through an IV so requires more direct patient care time from the Registered Nurse, IV pump, and tubing, whereas misoprostol is a tablet, administered only once, per vagina or orally, every 4 hours. Misoprostol is also very inexpensive comparatively; if equally or more efficacious than oxytocin, this could demonstrate quite a cost and time savings to Vanderbilt University Medical Center and other institutions. Safety of either drug is not in question.
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
- •Clinical candidate for labor induction utilizing either misoprostol or oxytocin
- •Greater than or equal to 18 years of age
- •Multiparous
- •Singleton gestation;
- •Greater than 37 weeks gestation;
- •Cephalic presentation
排除标准
- •Any clinical contraindication to misoprostol as induction drug
- •Age less than 18 years
- •Contraindication to vaginal birth
- •Nonreassuring fetal heart rate tracing
- •Prior uterine surgery
- •Active labor
- •Active maternal bleeding
- •Chorioamnionitis (infection)
研究组 & 干预措施
Vaginal Misoprostol
Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal
干预措施: Vaginal Misoprostol (Drug)
Intravenous Oxytocin
2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.
Route of administration: intravenous
干预措施: Intravenous Oxytocin (Drug)
结局指标
主要结局
Time From Induction to Vaginal Delivery
时间窗: Time to delivery in minutes from initiation of medication, up to 24 hours
Comparing the time to delivery in multiparas undergoing induction of labor with vaginal misoprostol or intravenous oxytocin.
次要结局
- NICU Admission and APGAR Less Than 7 at 5 Minutes(Through discharge from hospital)
- Neonatal APGAR Scores(At 1 minute and 5 minutes after delivery)
- Neonatal Weight at Delivery(Immediately following delivery)
- Maternal Delivery Outcomes(Through discharge from hospital)
- Maternal Satisfaction With Labor(6 weeks post-partum)
- Number of Participants With Excessive Uterine Activity Necessitating Treatment(Measured from initiation of medication until delivery time)
研究者
Angela Wilson-Liverman
Assistant Professor
Vanderbilt University Medical Center