Using IV Papaverine to Aid Cervical Ripening Before Labor Induction
The Effect of IV PAPAVERINE 80 mg Prior to Catheter Balloon Insertion on Bishop Score and Pain, Double Blinded Randomized Placebo Controlled Trial
This study tests if giving IV Papaverine can help women with an unripe cervix get ready for labor and feel less pain during the process.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Western Galilee Hospital-Nahariya Government |
| Locations | 1 site (Nahariya, Hazafon) |
| Trial ID | NCT05759364 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of administering IV Papaverine 80 mg prior to catheter balloon insertion in women with a Bishop score of less than 6, indicating an unriped cervix. The study aims to determine if Papaverine can enhance cervical ripening and reduce labor pain by relaxing smooth muscle in the cervix. Participants will be monitored for changes in the Bishop score and pain levels during the induction process. The trial will compare outcomes between those receiving Papaverine and a placebo group.
Who should consider this trial
Good fit: Ideal candidates are women over 18 years old, with a singleton pregnancy at term, a Bishop score less than 6, and intact membranes.
Not a fit: Patients with twin pregnancies, previous cesarean sections, or certain medical conditions such as severe fetal anomalies or psychiatric illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and less painful labor induction for women with an unriped cervix.
How similar studies have performed: Previous studies have shown promising results with the use of antispasmodic drugs like Papaverine in labor induction, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women with a singleton pregnancy, over the age of 18, pregnant at term (ie between weeks 37-42) * Bishop score is less than 6, for which a medical decision was made regarding the induction of labor by catheter * Vertex presentation, intact membranes * Viable fetus Exclusion Criteria: * Twin pregnancy * Women after caesarean section * Severe fetal anomalies * Women with vaginismus or vulvodynia * Women with psychiatric illnesses including depression and schizophrenia * Contraindication for vaginal delivery * A woman who is unable to sign a consent form * Women are known for supraventricular tachycardia * Women with tachycardia over 100 or arrhythmia * Known sensitivity to one of the components of the drug * Liver disease
Where this trial is running
Nahariya, Hazafon
- Galilee Medical Center — Nahariya, Hazafon, Israel (Recruiting)
Study contacts
- Principal investigator: Maya Frank Wolf, MD — Galilee Medical Center
- Study coordinator: Raneen Abu Shqara, MD
- Email: rabushqara@gmail.com
- Phone: +972549793591
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.