NCT06550232

IV PAPAVERINE Prior to Propess for Labor Induction

The Effect of IV PAPAVERINE 80 mg Prior to Propess on Bishop Score and Pain, Double Blinded Randomized Placebo Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Western Galilee Hospital-Nahariya · Other Government
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The investigators aim to evaluate the effect of administering papaverine prior to PGE2 insertion on changes in Bishop-scores and on the induction-to-delivery interval. Researchers will compare drug papaverine to a placebo

Detailed description

More than 22% of all pregnant women undergo induction of labor. Induction of labor is usually medically indicated for maternal and fetal related conditions; however, elective induction has become more common since the ARRIVE trial. Women with an unfavourable cervix, according to Bishop-score (\<6), are prone to higher induction failure rates and are candidates for cervical ripening. The cervix is composed of connective tissue and smooth-muscle located mainly beneath the internal os. Papaverine is an antispasmodic-musculotropic drug that targets smooth-muscle, resulting in decreased muscle spasm and subsequent smooth-muscle relaxation. The half-life of the drug is in the range of 0.5-2 hours, and its action starts 10 minutes after administration. Short-term use of papaverine during the first trimester has been reported as safe. However, outcome data are lacking of the use of mucosotropic-agents prior to PGE2 (propess) insertion. We will investigate this in a trial in which the co-primary outcomes were the change in Bishop-score after PGE2 extraction and the PGE2 insertion-to-delivery interval

Conditions

• Induced Vaginal Delivery

Interventions

Type	Name	Description
DRUG	Papaverine	Within 30-minutes prior to catheter insertion, women in the intervention group will receive IV-papaverine 80 mg in 100 ml 0.9% saline
OTHER	placebo	I.V Sallne

Timeline

• Start date: 2024-08-12
• Primary completion: 2025-03-23
• Completion: 2025-03-23
• First posted: 2024-08-12
• Last updated: 2025-06-26

Locations

1 site across 1 country: Israel