IV PAPAVERINE Prior to Propess for Labor Induction

Western Galilee Hospital-Nahariya

Status and phase: Not yet enrolling; Phase 4

Conditions: Induced Vaginal Delivery

Treatments: Drug: Papaverine; Other: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06550232

0112-24-NHR

Details and patient eligibility

About

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.

Full 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

Enrollment: 110 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• singleton term pregnancy
• bishop score
• need for labor induction with PGE2
• vertex presentation
• viable fetus

Exclusion criteria

• Prelabour rupture of membrane
• Twins pregnancy
• previous cesarean section
• allergy to the study medication
• fetal anomaly contraindications for vaginal delivery
• maternal supraventricular tachicardia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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110 participants in 2 patient groups, including a placebo group

papaverine arm

Active Comparator group

Description:

IV-papaverine 80 mg in 100 ml 0.9% saline, once

Treatment:

Drug: Papaverine

Control arm

Placebo Comparator group

Description:

I.V 100 ml 0.9% saline

Treatment:

Other: placebo