NCT04299438终止3 期
Propranolol Rescue of Prolonged Labor (PROPEL): A Randomized, Double-blind, Placebo-controlled Multicenter Investigation of Propranolol's Effect on Cesarean Delivery Rate Among Women With Prolonged Labor
Lisa Levine2 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2020年7月14日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 164
- 试验地点
- 2
- 主要终点
- Mode of Delivery
研究概览
简要总结
A double-blind placebo controlled randomized trial comparing cesarean delivery rates in women given IV propranolol versus placebo for treatment of prolonged labor.
详细描述
A double-blind placebo controlled randomized trial comparing cesarean delivery rates in 326 women given IV propranolol (2 mg with one possible repeat dose greater than 2 hours later) versus IV placebo for treatment of prolonged labor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •English-speaking
- •>= 36 weeks gestation
- •Singleton pregnancy
- •Vertex presentation
- •No contraindication to a vaginal delivery
- •Meets at least one study criteria for prolonged labor:
- •cervical dilation <6 cm after ≥8 hours with ruptured membranes and receiving oxytocin OR
- •cervical dilation >=6 cm and <1 cm dilation change over ≥2 hours with ruptured membranes and receiving oxytocin
排除标准
- •Severe preeclampsia: as patients will be receiving magnesium and possibly labetalol for hypertension control
- •Receiving other beta blocker
- •Maternal heart rate < 70 beats per minute, systolic blood pressure <90 mmHg, or diastolic blood pressure <50 mmHg on two sets of vital signs in the 1 hour prior to study drug administration: given that bradycardia and hypotension are possible side effects of propranolol
- •History of any form of asthma: as this is a contraindication to beta blocker use
- •Diabetes requiring insulin in labor: given the potential risk of neonatal hypoglycemia in the neonate
- •Any cardiac condition for which β blockade is contraindicated (cardiogenic shock, sinus bradycardia, and greater than first degree heart block)
- •Known hypersensitivity to propranolol
- •Intrauterine fetal demise since different labor protocols are used in these women
- •Major fetal congenital anomaly since rate of cesarean may be inherently different in these women, unrelated to labor
研究组 & 干预措施
Propranolol
Active Comparator
IV Propranolol - 2mg; one possible repeat dose ≥2 hours later
干预措施: Propranolol Hydrochloride (Drug)
Placebo
Placebo Comparator
Normal saline placebo- 2 mL; one possible repeat dose ≥2 hours later
干预措施: Saline (Other)
结局指标
主要结局
Mode of Delivery
时间窗: From enrollment into the trial until delivery.
Number of participants with a cesarean delivery
次要结局
- Maternal Morbidity(from delivery through 4 weeks postpartum)
- Neonatal Morbidity(from delivery through hospital discharge, usually 2-4 days)
- Postpartum Hemorrhage(from time of delivery through hospital discharge, usually 2-4 days)
- Length of Labor(hours from start of labor or induction of labor to time of delivery)
- Chorioamnionitis(from start of labor through delivery)
研究者
Lisa Levine
Assistant Professor of Obstetrics and Gynecology
University of Pennsylvania
研究点 (2)
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