A Phase 4 interventional study of Papaverine arm and Placebo in Premature Rupture of Membranes, sponsored by Western Galilee Hospital-Nahariya. Recruiting at 1 site in Israel. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-08.
Sponsored by Western Galilee Hospital-Nahariya · Phase 4, Interventional, and Treatment
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
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.
100 studies on the registry are indexed under Fetal Membranes, Premature Rupture; 23 are open to participants now.
This study's planned enrollment of 110 is below the median of 150 across 59 interventional studies indexed under Fetal Membranes, Premature Rupture.
Browse Fetal Membranes, Premature Rupture studies →Western Galilee Hospital-Nahariya is the lead sponsor of 89 studies on the registry; 15 are open to participants now.
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Singleton pregnancy
Exclusion Criteria:
Multiple gestation
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IV-papaverine 80 mg in 100 ml 0.9% saline, once, 12 hours after rupture of membranes
Drug: Papaverine arm
I.V 100 ml 0.9% saline, 12 hours after rupture of membranes
Other: Placebo
given 12 houres after rupture of membranes
I.V seline
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 membranes
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 intervention
mode of delivary
Mode of delivery categorized as vaginal (spontaneous or operative) or cesarean delivery
Time frame: At delivery/birth
Plan to share: Yes — The authors are willing to share the data of the study upon request of the Editors.
Supporting information: Study protocol, Informed consent form, Clinical study report
No publications or documents are linked to this record.
Started Oct 2025 (actual). Primary completion is estimated for Oct 2027, 24 months after the start.
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Studies of the drug tested here: Papaverine
Fetal Membranes, Premature Rupture →
Western Galilee Hospital-Nahariya