Propranolol Versus Placebo for Induction of Labor in Nulliparous Patients: a Double-blind Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Time From Beginning of Induction to Delivery
研究概览
简要总结
A randomized, prospective trial will be offered to women admitted to the labor floors at Mount Sinai Medical Center for labor induction.
详细描述
Induction of labor is a common obstetric procedure, which is performed to provoke the onset of labor and lead to delivery of the fetus. While some early studies suggested a possible increased rate of cesarean with induction of labor, more recent meta-analyses have shown that induction does not influence this rate. There is data from small randomized studies that demonstrates the effectiveness of propranolol, a non-selective beta-blocker, for induction of labor. This literature suggests a decrease in the amount of time to delivery and a possible reduction in cesarean section rates when propranolol is used in conjunction with oxytocin for induction of labor compared to oxytocin alone.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Study drug and placebo will be randomized and mixed to appear identical by the Mount Sinai Investigational Drug Service (IDS). The randomization code will be kept by the lead pharmacist of the IDS until completion of the trial, at which point data will be unmasked.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Nulliparous women undergoing induction of labor
- •>37 weeks' gestational age
- •Non-anomalous, singleton cephalic presenting fetus.
排除标准
- •Multiple gestations, known fetal anomalies
- •Maternal cardiac or hypertensive disease
- •Chronic beta blocker use
- •Bronchial asthma
- •Maternal or fetal indication for immediate delivery.
研究组 & 干预措施
Propranolol
2mg of IV push
干预措施: Propranolol (Drug)
Placebo
an equivalent quantity in milliliters of normal saline
干预措施: Placebo (Drug)
结局指标
主要结局
Time From Beginning of Induction to Delivery
时间窗: average of 24 hours
The time of induction (based on time of foley balloon placement for cervical ripening or misoprostol administration) to the time of delivery of the infant.
次要结局
- Number of Fetus With Fetal Bradycardia(30 minutes from drug administration)
- Number of Participants With Various Mode of Delivery(average of 24 hours)
- Number of Participants With Postpartum Hemorrhage(30 minutes from drug administration)
- Number of Participants With Maternal Morbidity Composite Score = 1(average of 24 hours)
- Number of Neonates With Neonatal Outcome Composite Score = 1(Day 1)
- Number of Neonates With Hypoglycemia(Day 1)
- Duration of Latent(average of 24 hours)
- Number of Fetus With Heart Rate Decelerations(30 minutes from drug administration)
研究者
joanne stone
Professor
Icahn School of Medicine at Mount Sinai