The Effect of Papaverine on Labour in Term Premature Rupture of Membranes (PROM)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Time From Study Infusion to Delivery
研究概览
简要总结
This randomized, double-blind, placebo-controlled trial evaluates whether intravenous papaverine, administered as an adjunct to oxytocin, shortens the time to delivery in women with term premature rupture of membranes (PROM). Participants are randomized in a 1:1 ratio to receive either intravenous papaverine 80 mg in 100 mL of 0.9% saline or 100 mL of 0.9% saline as placebo, administered one hour after initiation of oxytocin. The primary outcome is the interval from study infusion to delivery. Secondary outcomes include mode of delivery and maternal and neonatal outcomes.
详细描述
Women hospitalized in the labor and delivery unit with term premature rupture of membranes at 37 weeks of gestation or later are screened for participation. Eligible participants have no active contractions, cervical dilation of less than 2 cm, vertex presentation, and a duration of membrane rupture between 2 and 12 hours.
Following informed consent, participants are randomized in a 1:1 ratio to receive intravenous papaverine 80 mg diluted in 100 mL of 0.9% saline or 100 mL of 0.9% saline as placebo. The study infusion is administered one hour after initiation of oxytocin.
Treatment allocation is blinded. One study-team member prepares the study solution according to the randomization table, while the remainder of the study team remains blinded to treatment allocation. The primary outcome is the interval from study infusion to delivery.
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
- Double (Participant, Care Provider)
盲法说明
Treatment allocation was known only to one study team member who prepared the study infusions according to the randomization list. Participants, treating clinicians, investigators, and personnel involved in outcome assessment remained blinded to treatment allocation. Study infusions were prepared in identical 100-mL normal saline bags and were labeled without revealing group assignment.
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Gestational age ≥37 weeks with term PROM
- •No active contractions
- •Cervical dilation <2 cm
- •Vertex presentation
- •PROM duration between 2 and 12 hours
排除标准
- •Previous cesarean delivery
- •Contraindication to vaginal delivery
- •Known fetal malformation
- •Known allergy to papaverine
- •Cardiac arrhythmia
- •Hepatitis or other hepatic disease
- •Atrioventricular (AV) block
- •Congestive heart disease
- •Recent ischemic heart disease
- •Increased intracranial pressure
- •Active labor, defined as cervical dilation ≥6 cm
- •Contraindication to uterine relaxation, including significant uterine bleeding or fetal distress Active infection or chorioamnionitis Use of medications with potentially hazardous interactions with papaverine
研究组 & 干预措施
Placebo
Participants received 100 mL of intravenous 0.9% normal saline as placebo.
干预措施: Normal Saline Placebo Infusion (Drug)
Papaverine
Participants received intravenous papaverine 80 mg diluted in 100 mL of 0.9% normal saline.
干预措施: Papaverine (Drug)
结局指标
主要结局
Time From Study Infusion to Delivery
时间窗: From administration of the study infusion until delivery, assessed up to 48 hours
Time, measured in hours, from administration of the assigned study infusion (papaverine or placebo) to delivery.
次要结局
- Postpartum Hemorrhage(From rupture of membranes until delivery, assessed up to 48 hours)
- Mode of Delivery(From rupture of membranes until delivery, assessed up to 48 hours)
- Maternal Infectious Complications(From rupture of membranes until delivery, assessed up to 48 hours)
- Apgar Score at 5 Minutes(5 minutes after birth)
- Umbilical Cord pH Below 7.1(At birth, based on umbilical artery cord blood sampling)
- Neonatal Infection(From birth through neonatal hospital discharge, assessed up to 7 days after birth)