Papaverine given through IV to help with term PROM labor

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 randomized, double-blind, placebo-controlled study enrolls pregnant individuals at 37 weeks or later with term PROM and no active labor. Participants receive either intravenous papaverine 80 mg in saline or saline placebo, one hour after starting oxytocin, with treatment allocation kept blinded. The main goal is to measure the time from study infusion to delivery, while secondary outcomes include mode of delivery and maternal and neonatal outcomes. Eligible women are 18 or older, with minimal cervical dilation and specific exclusion criteria to ensure safety. The study is led by Wolfson Medical Center and conducted at The Edith Wolfson Medical Center in Holon, Israel.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥18 years
* Gestational age ≥37 weeks with term PROM
* No active contractions
* Cervical dilation \<2 cm
* Vertex presentation
* PROM duration between 2 and 12 hours

Exclusion Criteria:

* Previous cesarean delivery
* Contraindication to vaginal delivery
* Known fetal malformation
* Known allergy to papaverine
* Cardiac arrhythmia
* Glaucoma
* Hepatitis or other hepatic disease
* Atrioventricular (AV) block
* Congestive heart disease
* Recent ischemic heart disease
* Increased intracranial pressure
* Active labor, defined as cervical dilation ≥6 cm
* Contraindication to uterine relaxation, including significant uterine bleeding or fetal distress Active infection or chorioamnionitis Use of medications with potentially hazardous interactions with papaverine

Where it's running

• The Edith Wolfson Medical Center
  Holon, Israel Recruiting

Study contacts

• Study coordinator: Eliel Kedar Sade, MD
• Email: elielbob@gmaill.com
• Phone: +972-52-6008068

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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.