Papaverine to shorten the second stage of labor after double-balloon cervical ripening
Use of Papaverine to Shorten the Second Stage/Duration of Labor in Pregnant Women After Cervical Ripening by Double-balloon Catheter
We will test whether a single IV dose of papaverine given right after removing a double-balloon catheter can shorten labor for term pregnant women having labor induced.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 184 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Hillel Yaffe Medical Center Government |
| Locations | 1 site (Hadera) |
| Trial ID | NCT07237880 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized, double-blind, placebo-controlled trial enrolling term (37–42 weeks) singleton pregnancies admitted for induction with a double-balloon catheter. After catheter removal participants are randomized 1:1 to receive either 80 mg IV papaverine or an identical-appearing saline placebo given by a midwife who does not make clinical decisions. Clinical staff and participants remain blinded to allocation, and outcomes focus on labor duration and progression after mechanical cervical ripening. The protocol excludes prior cesarean delivery, multiple gestation, contraindications to vaginal birth, known major fetal anomaly, or hypersensitivity to papaverine.
Who should consider this trial
Good fit: Ideal candidates are pregnant people aged 18–50 with a singleton fetus at 37–42 weeks admitted for induction with a double-balloon catheter who plan a vaginal delivery and can give informed consent.
Not a fit: Patients with prior cesarean delivery, contraindications to vaginal delivery, immediate need for delivery, multiple gestation, major fetal anomaly, or known papaverine allergy are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this could shorten the duration of labor after mechanical cervical ripening and potentially reduce the need for additional interventions.
How similar studies have performed: Papaverine is used as an obstetric antispasmodic in practice, but its specific effect on labor progression after mechanical cervical ripening has been largely untested in randomized trials.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Hadera
- Hillel Yaffe Medical Center — Hadera, Israel (Recruiting)
Study contacts
- Principal investigator: Esther Maor-Sagie, MD — Hillel Yaffe Medical Center
- Study coordinator: Esther Maor-Sagie, MD
- Email: estimaorsagie@gmail.com
- Phone: 9727744248
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.