NCT07237880 Use of Papaverine to Shorten the Second Stage/Duration of Labor in Pregnant Women After Cervical Ripening by Double-balloon Catheter
| NCT ID | NCT07237880 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hillel Yaffe Medical Center |
| Condition | Labor, Induced |
| Study Type | INTERVENTIONAL |
| Enrollment | 184 participants |
| Start Date | 2025-04-22 |
| Primary Completion | 2027-04-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 184 participants in total. It began in 2025-04-22 with a primary completion date of 2027-04-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This prospective, randomized, double-blind controlled trial aims to evaluate whether intravenous papaverine, administered immediately after the removal of a double-balloon catheter used for cervical ripening, can shorten the duration of labor in term pregnant women undergoing induction of labor. Papaverine is an antispasmodic medication that relaxes smooth muscle and is commonly used in obstetrics, although its effect on labor progression following mechanical cervical ripening has not been fully studied. Eligible participants include nulliparous and multiparous women with a singleton pregnancy at 37-42 weeks, admitted for induction of labor with a double-balloon catheter. After catheter removal, participants will be randomized in a 1:1 ratio to receive either 80 mg intravenous papaverine or placebo (normal saline), administered by the midwife who is not involved in clinical decision-making. Clinical staff and participants will remain blinded to group allocation. The primary outcomes are the time from drug administration to complete cervical dilation and the duration of the second stage of labor. Secondary outcomes include mode of delivery, maternal complications (such as perineal tears and postpartum hemorrhage), oxytocin augmentation duration and maximum dose, and neonatal outcomes. This study seeks to determine whether papaverine can safely and effectively reduce labor duration following mechanical cervical ripening.
Eligibility Criteria
Inclusion Criteria: * Pregnant individuals aged 18-50 years * Singleton pregnancy * Gestational age 37-42 weeks * Admission for induction of labor with a double-balloon catheter * Planned vaginal delivery * Ability to provide informed consent Exclusion Criteria: * Previous cesarean delivery * Multiple gestation * Contraindication to vaginal delivery * Known hypersensitivity to papaverine * Known major fetal anomaly * Any condition requiring immediate delivery or precluding safe participation (as determined by the treating physician)
Contact & Investigator
Esther Maor-Sagie, MD
PRINCIPAL INVESTIGATOR
Hillel Yaffe Medical Center
Frequently Asked Questions
Who can join the NCT07237880 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Labor, Induced. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07237880 currently recruiting?
Yes, NCT07237880 is actively recruiting participants. Contact the research team at estimaorsagie@gmail.com for enrollment information.
Where is the NCT07237880 trial being conducted?
This trial is being conducted at Hadera, Israel.
Who is sponsoring the NCT07237880 clinical trial?
NCT07237880 is sponsored by Hillel Yaffe Medical Center. The principal investigator is Esther Maor-Sagie, MD at Hillel Yaffe Medical Center. The trial plans to enroll 184 participants.