Use of Papaverine to Shorten the Second Stage/Duration of Labor in Pregnant Women After Cervical Ripening by Double-balloon Catheter
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Time from study drug administration to complete cervical dilation
研究概览
简要总结
This prospective, randomized, double-blind controlled trial aims to evaluate whether intravenous papaverine, administered immediately after the removal of a double-balloon catheter used for cervical ripening, can shorten the duration of labor in term pregnant women undergoing induction of labor. Papaverine is an antispasmodic medication that relaxes smooth muscle and is commonly used in obstetrics, although its effect on labor progression following mechanical cervical ripening has not been fully studied.
Eligible participants include nulliparous and multiparous women with a singleton pregnancy at 37-42 weeks, admitted for induction of labor with a double-balloon catheter. After catheter removal, participants will be randomized in a 1:1 ratio to receive either 80 mg intravenous papaverine or placebo (normal saline), administered by the midwife who is not involved in clinical decision-making. Clinical staff and participants will remain blinded to group allocation.
The primary outcomes are the time from drug administration to complete cervical dilation and the duration of the second stage of labor. Secondary outcomes include mode of delivery, maternal complications (such as perineal tears and postpartum hemorrhage), oxytocin augmentation duration and maximum dose, and neonatal outcomes.
This study seeks to determine whether papaverine can safely and effectively reduce labor duration following mechanical cervical ripening.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant individuals aged 18-50 years
- •Singleton pregnancy
- •Gestational age 37-42 weeks
- •Admission for induction of labor with a double-balloon catheter
- •Planned vaginal delivery
- •Ability to provide informed consent
排除标准
- •Previous cesarean delivery
- •Multiple gestation
- •Contraindication to vaginal delivery
- •Known hypersensitivity to papaverine
- •Known major fetal anomaly
- •Any condition requiring immediate delivery or precluding safe participation (as determined by the treating physician)
研究组 & 干预措施
Arm Name: Papaverine
"Participants receive 80 mg intravenous papaverine immediately after removal of the double-balloon catheter, together with initiation of oxytocin augmentation."
干预措施: Papaverine 80 mg IV (Drug)
Arm Type: Placebo Comparator
"Participants receive intravenous normal saline immediately after removal of the double-balloon catheter, together with initiation of oxytocin augmentation."
干预措施: Placebo (Normal Saline) (Drug)
结局指标
主要结局
Time from study drug administration to complete cervical dilation
时间窗: From study drug administration to complete cervical dilation, up to 24 hours.
Time in hours from intravenous administration of papaverine or placebo after removal of the double-balloon catheter until complete cervical dilation (10 cm), as documented in the partogram/electronic medical record.
次要结局
未报告次要终点