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

RecruitingNAAges 18 Years - 50 YearsFemaleHillel Yaffe Medical Center
NCT07237880 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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-mak

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * 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)
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What it tests

  • Papaverine 80 mg IV
  • Placebo (Normal Saline)
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Where

1 site
Hillel Yaffe Medical Center
Hadera, Israel
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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