Premature Rupture of Fetal Membranes
Conditions
Keywords
Term PROM, Premature rupture of membranes, Papaverine, Labor induction, Oxytocin
Brief summary
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.
Detailed description
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.
Interventions
DRUGPapaverine
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.
Sponsors
Wolfson Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
Treatment allocation was known only to one study team member who prepared the study infusions according to the randomization list. Participants, treating clinicians, investigators, and personnel involved in outcome assessment remained blinded to treatment allocation. Study infusions were prepared in identical 100-mL normal saline bags and were labeled without revealing group assignment.
Intervention model description
Participants were randomized in a 1:1 ratio to receive intravenous papaverine or placebo in two parallel groups.
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time From Study Infusion to Delivery | From administration of the study infusion until delivery, assessed up to 48 hours | Time, measured in hours, from administration of the assigned study infusion (papaverine or placebo) to delivery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mode of Delivery | From rupture of membranes until delivery, assessed up to 48 hours | Mode of delivery, categorized as vaginal or cesarean delivery |
| Maternal Infectious Complications | From rupture of membranes until delivery, assessed up to 48 hours | Proportion of participants with maternal infectious complications |
| Postpartum Hemorrhage | From rupture of membranes until delivery, assessed up to 48 hours | Proportion of participants with postpartum hemorrhage |
| Apgar Score at 5 Minutes | 5 minutes after birth | Apgar score recorded 5 minutes after birth, ranging from 0 to 10 |
| Umbilical Cord pH Below 7.1 | At birth, based on umbilical artery cord blood sampling | Proportion of neonates with umbilical cord blood pH below 7.1 |
| Neonatal Infection | From birth through neonatal hospital discharge, assessed up to 7 days after birth | Proportion of neonates diagnosed with neonatal infection |
Countries
Israel
Contacts
CONTACTEliel Kedar Sade, MD
CONTACTOrnit Cohen
Outcome results
None listed