IV PAPAVERINE Prior to Propess for Labor Induction
- Conditions
- Induced Vaginal Delivery
- Interventions
- Other: placebo
- Registration Number
- NCT06550232
- Lead Sponsor
- Western Galilee Hospital-Nahariya
- Brief Summary
We aim to evaluate the effect of administering papaverine prior to PGE2 (propess) insertion on changes in Bishop-scores and on the induction-to-delivery interval.
- 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
- NOT_YET_RECRUITING
- 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 Delta Bishop score 24 hours The bishop score pre- and post-catheter-balloon expulsion
visual analogue scale score 24 hours The procedure related pain was assessed using a 10-point visual analogue scale
- Secondary Outcome Measures
Name Time Method PGE2 insertion-to-delivery interval hours time interval from PGE2 insertion to delivery of the newborn