Use of Papaverine to Shorten the Second Stage/Duration of Labor in Pregnant Women After Cervical Ripening by Double-balloon Catheter

Обзор

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.

Вмешательства

• Препарат Papaverine 80 mg IV
  Single intravenous dose of 80 mg papaverine administered immediately after removal of the double-balloon cervical ripening catheter. The medication is given by the midwife as part of the randomized, double-blind protocol, followed by initiation of oxytocin augmentation according to standard labor management.
• Препарат Placebo (Normal Saline)
  Single intravenous dose of normal saline administered immediately after removal of the double-balloon cervical ripening catheter. The placebo is administered in an identical manner to the papaverine intervention as part of the randomized, double-blind protocol, followed by initiation of oxytocin augmentation.

Первичные конечные точки

• Time from study drug administration to complete cervical dilation [Срок оценки: From study drug administration to complete cervical dilation, up to 24 hours.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Израиль · 1 центр

• Hillel Yaffe Medical Center — Hadera

Идентификаторы

NCT: NCT07237880 · 0100-24-HYMC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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