Intravenous Papaverine for Term Prelabor Rupture of Membranes
2026年9月14日 更新者：Wolfson Medical Center
The Effect of Papaverine on Labour in Term Premature Rupture of Membranes (PROM)
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
200
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Ornit Cohen
- 电话号码：+972-3-5028399
- 邮箱：ornitc@wmc.gov.il
研究联系人备份
- 姓名：Eliel Kedar Sade, MD
- 电话号码：+972-52-6008068
- 邮箱：elielbob@gmaill.com
学习地点
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Holon、以色列、5822012
- 招聘中
- The Edith Wolfson Medical Center
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接触：
- Ornit Cohen
- 电话号码：+972-3-5028399
- 邮箱：ornitc@wmc.gov.il
-
接触：
- Eliel Kedar Sade, MD
- 电话号码：+972-52-6008068
- 邮箱：elielbob@gmaill.com
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- Previous cesarean delivery
- Contraindication to vaginal delivery
- Known fetal malformation
- Known allergy to papaverine
- Cardiac arrhythmia
- Glaucoma
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Papaverine
Participants received intravenous papaverine 80 mg diluted in 100 mL of 0.9% normal saline.
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Papaverine 80 mg diluted in 100 mL of 0.9% normal saline, administered intravenously as a single study infusion.
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安慰剂比较：Placebo
Participants received 100 mL of intravenous 0.9% normal saline as placebo.
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100 mL of 0.9% normal saline, administered intravenously as a single placebo study infusion.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Time From Study Infusion to Delivery
大体时间：From administration of the study infusion until delivery, assessed up to 48 hours
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Time, measured in hours, from administration of the assigned study infusion (papaverine or placebo) to delivery.
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From administration of the study infusion until delivery, assessed up to 48 hours
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Mode of Delivery
大体时间：From rupture of membranes until delivery, assessed up to 48 hours
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Mode of delivery, categorized as vaginal or cesarean delivery
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From rupture of membranes until delivery, assessed up to 48 hours
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Maternal Infectious Complications
大体时间：From rupture of membranes until delivery, assessed up to 48 hours
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Proportion of participants with maternal infectious complications
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From rupture of membranes until delivery, assessed up to 48 hours
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Postpartum Hemorrhage
大体时间：From rupture of membranes until delivery, assessed up to 48 hours
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Proportion of participants with postpartum hemorrhage
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From rupture of membranes until delivery, assessed up to 48 hours
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Apgar Score at 5 Minutes
大体时间：5 minutes after birth
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Apgar score recorded 5 minutes after birth, ranging from 0 to 10
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5 minutes after birth
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Umbilical Cord pH Below 7.1
大体时间：At birth, based on umbilical artery cord blood sampling
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Proportion of neonates with umbilical cord blood pH below 7.1
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At birth, based on umbilical artery cord blood sampling
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Neonatal Infection
大体时间：From birth through neonatal hospital discharge, assessed up to 7 days after birth
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Proportion of neonates diagnosed with neonatal infection
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From birth through neonatal hospital discharge, assessed up to 7 days after birth
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Prelabor Rupture of Membranes: ACOG Practice Bulletin, Number 217. Obstet Gynecol. 2020 Mar;135(3):e80-e97. doi: 10.1097/AOG.0000000000003700.
- Rohwer AC, Khondowe O, Young T. Antispasmodics for labour. Cochrane Database Syst Rev. 2013 Jun 5;2013(6):CD009243. doi: 10.1002/14651858.CD009243.pub3.
- Middleton P, Shepherd E, Flenady V, McBain RD, Crowther CA. Planned early birth versus expectant management (waiting) for prelabour rupture of membranes at term (37 weeks or more). Cochrane Database Syst Rev. 2017 Jan 4;1(1):CD005302. doi: 10.1002/14651858.CD005302.pub3.
- Singh KC, Jain P, Goel N, Saxena A. Drotaverine hydrochloride for augmentation of labor. Int J Gynaecol Obstet. 2004 Jan;84(1):17-22. doi: 10.1016/s0020-7292(03)00276-5.
- Abu Shqara R, Nakhleh Francis Y, Goldinfeld G, Haddad Y, Sgayer I, Lavinsky M, Lowenstein L, Frank Wolf M. Papaverine prior to catheter balloon insertion for labor induction: a randomized controlled trial. Am J Obstet Gynecol MFM. 2024 Jul;6(7):101388. doi: 10.1016/j.ajogmf.2024.101388. Epub 2024 May 31.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年3月20日
初级完成 (估计的)
2027年4月21日
研究完成 (估计的)
2027年4月21日
研究注册日期
首次提交
2026年9月7日
首先提交符合 QC 标准的
2026年9月14日
首次发布 (实际的)
2026年9月17日
研究记录更新
最后更新发布 (实际的)
2026年9月17日
上次提交的符合 QC 标准的更新
2026年9月14日
最后验证
2026年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.