Galilee Medical Center
Nahariya, Israel
Location status: Recruiting
NCT Number: NCT07517796
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
Interested in participating?
Request Info18 year–45 year
Female
Interventional
Phase 4
Nahariya, Israel
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
given 12 houres after rupture of membranes
I.V seline
Time frame: up to 5 days from rupture of membranes
Time from rupture of membrane to delivery, measured in hours, including pre and post intervention periods
Time frame: baseline to 6-12 hours after intervention
Bishop score messured at admission and 18 houres after rupture of membranes, and comparing the delta bishop scores between the groups
Time frame: At delivery/birth
Mode of delivery categorized as vaginal (spontaneous or operative) or cesarean delivery
Contact information is provided by the study sponsor or research team.
Western Galilee Hospital-Nahariya
Other Gov
I.V Papavrine for Labor Induction in Term PROM: A Prospective Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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