Papaverine to shorten the second stage of labor after double-balloon cervical ripening

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized, double-blind, placebo-controlled trial enrolling term (37–42 weeks) singleton pregnancies admitted for induction with a double-balloon catheter. After catheter removal participants are randomized 1:1 to receive either 80 mg IV papaverine or an identical-appearing saline placebo given by a midwife who does not make clinical decisions. Clinical staff and participants remain blinded to allocation, and outcomes focus on labor duration and progression after mechanical cervical ripening. The protocol excludes prior cesarean delivery, multiple gestation, contraindications to vaginal birth, known major fetal anomaly, or hypersensitivity to papaverine.

Why it matters

Who can join: the full rules

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)

Where it's running

• Hillel Yaffe Medical Center
  Hadera, Israel Recruiting

Study contacts

• Principal investigator: Esther Maor-Sagie, MD — Hillel Yaffe Medical Center
• Study coordinator: Esther Maor-Sagie, MD
• Email: estimaorsagie@gmail.com
• Phone: 9727744248

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.