I.V Papavrine for Labor Induction in Term PROM
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Papaverine arm, Placebo.
- Who it may be relevant to
- Registry conditions: Premature Rupture of Membranes. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
I.V Papavrine for Labor Induction in Term PROM: A Prospective Randomized Controlled Trial
Overview
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
Detailed description
Prelabor rupture of membranes (PROM) at term complicates approximately 8% of pregnancies and is associated with increasing maternal and neonatal infectious morbidity as the latency period to delivery lengthens. Consequently, most clinical guidelines recommend active management with labor induction within 24 hours following membrane rupture. Cervical status at the time of induction plays a critical role in labor outcomes, and women with an unfavorable cervix, commonly defined as a Bishop score below 8, are at increased risk of prolonged labor and induction failure. The uterine cervix is composed primarily of connective tissue, with smooth muscle accounting for approximately 15% of its structure and concentrated mainly beneath the internal cervical os. Papaverine is a musculotropic antispasmodic agent that acts directly on smooth muscle, leading to reduced muscle spasm and enhanced relaxation. The pharmacokinetic profile of papaverine includes a rapid onset of action within approximately 10 minutes and a short half-life of 0.5-2 hours, making it a potentially suitable adjunct during early labor. Antispasmodic agents have been shown to accelerate cervical dilatation and shorten the first stage of labor; however, their role in the management of term PROM has not been systematically evaluated. We therefore aim to investigate whether intravenous administration of papaverine in women with term PROM shortens the interval from membrane rupture to delivery and improves cervical ripening and maternal and neonatal outcomes.
Interventions
- Drug Papaverine arm
given 12 houres after rupture of membranes - Other Placebo
I.V seline
Primary outcome measures
- Time interval from rupture of membranes to delivery [Time frame: up to 5 days from rupture of membranes]
Secondary outcome measures (2)
- change in bishop score following intervention [Time frame: baseline to 6-12 hours after intervention]
- mode of delivary [Time frame: At delivery/birth]
Eligibility criteria
Inclusion 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
Exclusion criteria
- • Multiple gestation
- Previous cesarean delivery
- Major fetal anomalies
- Contraindication to vaginal delivery
- Meconium-stained amniotic fluid
- Suspected chorioamnionitis
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Israel · 1 center
- Galilee Medical Center — Nahariya
Identifiers
NCT: NCT07517796 · 0152-25-NHR