An interventional study of Papaverine and Normal Saline Placebo Infusion in Premature Rupture of Fetal Membranes, sponsored by Wolfson Medical Center. Recruiting at 1 site in Israel. Open to female participants. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Wolfson Medical Center · Not applicable, Interventional, and Treatment
This randomized, double-blind, placebo-controlled trial evaluates whether intravenous papaverine, administered as an adjunct to oxytocin, shortens the time to delivery in women with term premature rupture of membranes (PROM). Participants are randomized in a 1:1 ratio to receive either intravenous papaverine 80 mg in 100 mL of 0.9% saline or 100 mL of 0.9% saline as placebo, administered one hour after initiation of oxytocin. The primary outcome is the interval from study infusion to delivery. Secondary outcomes include mode of delivery and maternal and neonatal outcomes.
Women hospitalized in the labor and delivery unit with term premature rupture of membranes at 37 weeks of gestation or later are screened for participation. Eligible participants have no active contractions, cervical dilation of less than 2 cm, vertex presentation, and a duration of membrane rupture between 2 and 12 hours.
Following informed consent, participants are randomized in a 1:1 ratio to receive intravenous papaverine 80 mg diluted in 100 mL of 0.9% saline or 100 mL of 0.9% saline as placebo. The study infusion is administered one hour after initiation of oxytocin.
Treatment allocation is blinded. One study-team member prepares the study solution according to the randomization table, while the remainder of the study team remains blinded to treatment allocation. The primary outcome is the interval from study infusion to delivery.
100 studies on the registry are indexed under Fetal Membranes, Premature Rupture; 23 are open to participants now.
This study's planned enrollment of 200 is above the median of 150 across 59 interventional studies indexed under Fetal Membranes, Premature Rupture.
Browse Fetal Membranes, Premature Rupture studies →Wolfson Medical Center is the lead sponsor of 118 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received intravenous papaverine 80 mg diluted in 100 mL of 0.9% normal saline.
Drug: Papaverine
Participants received 100 mL of intravenous 0.9% normal saline as placebo.
Drug: Normal Saline Placebo Infusion
Papaverine 80 mg diluted in 100 mL of 0.9% normal saline, administered intravenously as a single study infusion.
100 mL of 0.9% normal saline, administered intravenously as a single placebo study infusion.
Also known as: 0.9% Sodium Chloride
Time From Study Infusion to Delivery
Time, measured in hours, from administration of the assigned study infusion (papaverine or placebo) to delivery.
Time frame: From administration of the study infusion until delivery, assessed up to 48 hours
Mode of Delivery
Mode of delivery, categorized as vaginal or cesarean delivery
Time frame: From rupture of membranes until delivery, assessed up to 48 hours
Maternal Infectious Complications
Proportion of participants with maternal infectious complications
Time frame: From rupture of membranes until delivery, assessed up to 48 hours
Postpartum Hemorrhage
Proportion of participants with postpartum hemorrhage
Time frame: From rupture of membranes until delivery, assessed up to 48 hours
Apgar Score at 5 Minutes
Apgar score recorded 5 minutes after birth, ranging from 0 to 10
Time frame: 5 minutes after birth
Umbilical Cord pH Below 7.1
Proportion of neonates with umbilical cord blood pH below 7.1
Time frame: At birth, based on umbilical artery cord blood sampling
Neonatal Infection
Proportion of neonates diagnosed with neonatal infection
Time frame: From birth through neonatal hospital discharge, assessed up to 7 days after birth
Plan to share: No
Started Mar 2025 (actual). Primary completion is estimated for Apr 2027, 25 months after the start.
Of 23 interventional studies with no phase under Fetal Membranes, Premature Rupture, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 62. This study's planned 25 months is below that.
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Studies of the drug tested here: Papaverine
Fetal Membranes, Premature Rupture →