I.V Papavrine for Labor Induction in Term PROM
ConditionPremature Rupture of Membranes
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorWestern Galilee Hospital-Nahariya
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
• Singleton pregnancy
Term gestation (37-42 weeks)
Term PROM prior to active labor
Duration of PROM <12 hours at enrollment
Disqualifiers
• Multiple gestation
Previous cesarean delivery
Major fetal anomalies
Contraindication to vaginal delivery
Trial design
Design model
Parallel
Treatments tested in this trial
Papaverine arm
Druggiven 12 houres after rupture of membranes
Placebo
Other interventionI.V seline
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: papaverine armActive comparator 1 intervention
Group B: Control armPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Time interval from rupture of membranes to delivery
Time from rupture of membrane to delivery, measured in hours, including pre and post intervention periods
Time frame
up to 5 days from rupture of membranesSecondary outcomes
1
change in bishop score following intervention
Bishop score messured at admission and 18 houres after rupture of membranes, and comparing the delta bishop scores between the groups
Time frame
baseline to 6-12 hours after intervention2
mode of delivary
Mode of delivery categorized as vaginal (spontaneous or operative) or cesarean delivery
Time frame
At delivery/birthSponsors and contacts
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Source ClinicalTrials.gov