IV PAPAVERINE Prior to Propess for Labor Induction
- Registration Number
- NCT06550232
- Lead Sponsor
- Western Galilee Hospital-Nahariya
- Brief 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 110
- singleton term pregnancy
- bishop score
- need for labor induction with PGE2
- vertex presentation
- viable fetus
- Prelabour rupture of membrane
- Twins pregnancy
- previous cesarean section
- allergy to the study medication
- fetal anomaly contraindications for vaginal delivery
- maternal supraventricular tachicardia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control arm placebo I.V 100 ml 0.9% saline papaverine arm Papaverine IV-papaverine 80 mg in 100 ml 0.9% saline, once
- Primary Outcome Measures
Name Time Method the time from propess insertion until delivery 72 hours induction to delivery time
Delta Bishop score 24 hours The bishop score before and after propess insertion
- Secondary Outcome Measures
Name Time Method maternal satisfaction scores 24 hours maternal satisfaction on 1-5 scale. higher scores mean higher satisfaction
visual analogue scale score 24 hours pain assessment using a 10-point visual analogue scale
Trial Locations
- Locations (1)
Galilee Medical Center
🇮🇱Nahariyya, Israel
Galilee Medical Center🇮🇱Nahariyya, Israel