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临床试验/NCT07517796
NCT07517796招募中4 期

I.V Papavrine for Labor Induction in Term PROM: A Prospective Randomized Controlled Trial

Western Galilee Hospital-Nahariya1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2025年10月22日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
入组人数
110
试验地点
1
主要终点
Time interval from rupture of membranes to delivery

研究概览

简要总结

This prospective randomized controlled trial aims to evaluate whether intravenous administration of papaverine 12 hours after term PROM reduces the interval from membrane rupture to delivery and improves maternal and neonatal outcomes. Researchers will compare drug papaverine to a placebo

详细描述

Prelabor rupture of membranes (PROM) at term complicates approximately 8% of pregnancies and is associated with increasing maternal and neonatal infectious morbidity as the latency period to delivery lengthens. Consequently, most clinical guidelines recommend active management with labor induction within 24 hours following membrane rupture. Cervical status at the time of induction plays a critical role in labor outcomes, and women with an unfavorable cervix, commonly defined as a Bishop score below 8, are at increased risk of prolonged labor and induction failure. The uterine cervix is composed primarily of connective tissue, with smooth muscle accounting for approximately 15% of its structure and concentrated mainly beneath the internal cervical os. Papaverine is a musculotropic antispasmodic agent that acts directly on smooth muscle, leading to reduced muscle spasm and enhanced relaxation. The pharmacokinetic profile of papaverine includes a rapid onset of action within approximately 10 minutes and a short half-life of 0.5-2 hours, making it a potentially suitable adjunct during early labor. Antispasmodic agents have been shown to accelerate cervical dilatation and shorten the first stage of labor; however, their role in the management of term PROM has not been systematically evaluated. We therefore aim to investigate whether intravenous administration of papaverine in women with term PROM shortens the interval from membrane rupture to delivery and improves cervical ripening and maternal and neonatal outcomes.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

The group allocation will be double blind. The randomization table will be available only to one member of the study, who will prepare the medications according to the allocated intervention. Participants will receive intravenous 0.9% normal saline with or without papaverine. The same bottles of normal saline will be use for the papaverine and placebo groups. Accordingly, the participants will be masked for the intervention. The participants, the researchers including the obstetricians who assess the bishop score, the caregiver nurse who administrated the medication, the data collector, and the statistician will be blinded to the group allocations throughout the study

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • • Singleton pregnancy
  • Term gestation (37-42 weeks)
  • Term PROM prior to active labor
  • Duration of PROM <12 hours at enrollment
  • Bishop score <8
  • Cephalic presentation
  • Viable fetus with reassuring fetal heart rate

排除标准

  • • Multiple gestation
  • Previous cesarean delivery
  • Major fetal anomalies
  • Contraindication to vaginal delivery
  • Meconium-stained amniotic fluid
  • Suspected chorioamnionitis

研究组 & 干预措施

papaverine arm

Active Comparator

IV-papaverine 80 mg in 100 ml 0.9% saline, once, 12 hours after rupture of membranes

干预措施: Papaverine arm (Drug)

Control arm

Placebo Comparator

I.V 100 ml 0.9% saline, 12 hours after rupture of membranes

干预措施: Placebo (Other)

结局指标

主要结局

Time interval from rupture of membranes to delivery

时间窗: up to 5 days from rupture of membranes

Time from rupture of membrane to delivery, measured in hours, including pre and post intervention periods

次要结局

  • change in bishop score following intervention(baseline to 6-12 hours after intervention)
  • mode of delivary(At delivery/birth)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Dr. Maya Wolf

Head of Fetal Maternal Unit

Western Galilee Hospital-Nahariya

研究点 (1)

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