Health TrialsbyHealthPanel

Intravenous Papaverine for Term Prelabor Rupture of Membranes

ConditionPremature Rupture of Fetal Membranes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorWolfson Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Gestational age ≥37 weeks with term PROM

No active contractions

Cervical dilation <2 cm

Disqualifiers

Previous cesarean delivery

Contraindication to vaginal delivery

Known fetal malformation

Known allergy to papaverine

Trial design

Design model

Parallel

Treatments tested in this trial

  • Papaverine

    Drug

    Papaverine 80 mg diluted in 100 mL of 0.9% normal saline, administered intravenously as a single study infusion.

  • Normal Saline Placebo Infusion

    Drug

    100 mL of 0.9% normal saline, administered intravenously as a single placebo study infusion.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: PapaverineExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

Maternal Infectious Complications

Proportion of participants with maternal infectious complications

Time frame
From rupture of membranes until delivery, assessed up to 48 hours
3

Postpartum Hemorrhage

Proportion of participants with postpartum hemorrhage

Time frame
From rupture of membranes until delivery, assessed up to 48 hours
4

Apgar Score at 5 Minutes

Apgar score recorded 5 minutes after birth, ranging from 0 to 10

Time frame
5 minutes after birth

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wolfson Medical Center

Lead sponsor

Source ClinicalTrials.gov
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