跳至主要内容
临床试验/NCT06547437
NCT06547437尚未招募不适用

"Evaluating the Effectiveness of Papaverine as an Adjunct to Oxytocin for Labor Induction: A Randomized Controlled Trial"

Western Galilee Hospital-Nahariya0 个研究点目标入组 126 人开始时间: 2024年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
入组人数
126
主要终点
time to active delivery

研究概览

简要总结

This study aims to evaluate the efficacy and safety of combining papaverine with oxytocin for labor induction compared to oxytocin alone

详细描述

Labor induction is a common obstetric procedure aimed at stimulating uterine contractions to initiate labor, often due to medical or obstetric indications such as post-term pregnancy, preeclampsia, or fetal growth restriction. The primary objective is to achieve vaginal delivery while minimizing risks to both mother and child. Oxytocin, a synthetic analog of the natural hormone, is the most frequently used pharmacological agent for labor induction due to its effectiveness in promoting uterine contractions. However, its use is associated with complications, including uterine hyperstimulation, increased need for epidural analgesia, and higher rates of operative deliveries.

The potential of antispasmodics to aid in labor induction has been explored, with some studies indicating that these agents can reduce the duration of labor and enhance cervical dilation. The Cochrane review on antispasmodics for labor highlighted that these drugs, such as hyoscine butylbromide and drotaverine, could significantly reduce the duration of the first stage of labor and increase the rate of cervical dilation, although the overall quality of evidence was low. Despite these findings, further high-quality studies are recommended to substantiate these benefits and ensure safety.

Papaverine, a well-known smooth muscle relaxant traditionally used for treating vascular spasms, presents a promising adjunctive therapy for labor induction. By relaxing the smooth muscles of the cervix and uterus, papaverine may facilitate more efficient cervical ripening and enhance the effectiveness of oxytocin-induced contractions. Preliminary studies with other antispasmodics, such as butylscopolamine, have shown reductions in labor duration and improvements in labor progression without significant adverse effects, suggesting that papaverine might offer similar benefits.

This study aims to evaluate the efficacy and safety of combining papaverine with oxytocin for labor induction compared to oxytocin alone. The primary outcome will be the time to onset of active labor, with secondary outcomes including total duration of labor, rate of cesarean deliveries, maternal satisfaction, and adverse effects. By investigating this novel combination, the study seeks to provide new insights into optimizing labor induction protocols, ultimately improving maternal and neonatal outcomes.

Objective: To evaluate if adding papaverine to oxytocin reduces the time to active 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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

double blinded study

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women with a singleton pregnancy Over the age of 18 Term (between 37-42 weeks of gestation) A medical decision for labor induction using oxytocin. Cephalic presentation Viable fetus

排除标准

  • Twin pregnancy Women with a previous cesarean section Severe fetal anomalies Women with psychiatric disorders, including depression and schizophrenia. Contraindication to vaginal delivery Women unable to sign the consent form Women known to have SVT (supraventricular tachycardia). Women with a heart rate over 100 or arrhythmia Known sensitivity to any component of the drug Liver disease

研究组 & 干预措施

oxytocin plus papaverine

Active Comparator

Intervention Group: Combined use of papaverine (80 mg intravenous mg in 100 mL saline once concurrent with the start of oxytocin) and oxytocin.

干预措施: Papaverine (Drug)

oxytocin alone

Placebo Comparator

Control Group: Oxytocin plus 100 mL saline.

干预措施: normal saline (Drug)

结局指标

主要结局

time to active delivery

时间窗: 24 HOURS AFTER DELIVERY

time from labor induction till dilatation of 6 cm

次要结局

  • total length of labor(24 HOURS AFTER DELIVERY)
  • vaginal deliveries in 24 hours(24 HOURS AFTER DELIVERY)
  • cesarean delivery rate(ho24 HOURS AFTER DELIVERY)
  • length of second stage of labor(24 hours after delivery)

研究者

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

Inshirah Sgayer

DR inshirah sgayer galilee medical center

Western Galilee Hospital-Nahariya

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