Actively Recruiting
Intravenous Papaverine to Reduce Labor Duration After Double-Balloon Catheter Cervical Ripening in Pregnant Women Randomized Double-Blind Trial in Women Undergoing Labor Induction at 37-42 Weeks
Led by Hillel Yaffe Medical Center · Updated on 2026-01-06
184
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
This research aims to evaluate whether intravenous papaverine can shorten labor duration in women at term undergoing induction of labor using a double-balloon catheter for cervical ripening. The trial includes both women having their first baby and those who have had children before, focusing on those with a single baby between 37 and 42 weeks of pregnancy. Papaverine is an antispasmodic drug that relaxes smooth muscle and is commonly used in obstetrics, but its effect on labor after mechanical cervical ripening has not been fully studied. Participants are randomly assigned to receive either 80 mg of intravenous papaverine or a placebo of normal saline immediately after the removal of the double-balloon catheter. Both groups will begin oxytocin augmentation following this administration. The study is double-blinded, meaning neither the participants nor the clinical staff know who receives papaverine or placebo. The intervention is given by a midwife who is not involved in clinical decisions. During the study, researchers will monitor the time from drug administration to complete cervical dilation, and the length of the second stage of labor. They will also track delivery methods, maternal complications such as tears or hemorrhage, oxytocin use, and newborn outcomes. The study lasts until delivery, focusing on safety and whether papaverine affects labor progression, with participation lasting from catheter removal to delivery completion.
CONDITIONS
Brief Title
Use of Papaverine to Shorten the Second Stage/Duration of Labor in Pregnant Women After Cervical Ripening by Double-balloon Catheter
Research Team
E
Esther Maor-Sagie, MD
R
Rinat Gabbay-Benziv, Prof
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