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New treatment option for Premature Rupture of Membranes
Official title I.V Papavrine for Labor Induction in Term PROM
ClinicalTrials.gov ID: NCT07517796
What this study is testing
What is Papaverine arm?
Papaverine arm is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for premature rupture of membranes.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This prospective randomized controlled trial aims to evaluate whether intravenous administration of papaverine 12 hours after term PROM reduces the interval from membrane rupture to delivery and improves maternal and neonatal outcomes. Researchers will compare drug papaverine to a placebo
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only. Healthy volunteers may be eligible.
You may be able to join if
- Singleton pregnancy
- Term gestation (37-42 weeks)
- Term PROM prior to active labor
- Duration of PROM \<12 hours at enrollment
- Bishop score \<8
You likely can't join if
- Multiple gestation
- Previous cesarean delivery
- Major fetal anomalies
- Contraindication to vaginal delivery
- Meconium-stained amniotic fluid
- Suspected chorioamnionitis
See the full eligibility criteria
- Singleton pregnancy
- Term gestation (37-42 weeks)
- Term PROM prior to active labor
- Duration of PROM \<12 hours at enrollment
- Bishop score \<8
- Cephalic presentation
- Viable fetus with reassuring fetal heart rate
- Multiple gestation
- Previous cesarean delivery
- Major fetal anomalies
- Contraindication to vaginal delivery
- Meconium-stained amniotic fluid
- Suspected chorioamnionitis
The study team makes the final eligibility decision.
Where it's taking place
- Nahariya, Israel, Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nahariya, Israel, Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.