ClinicalTrials.Veeva

Menu

IV PAPAVERINE Prior to Propess for Labor Induction

W

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

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

Trial contacts and locations

0

Loading...

Central trial contact

maya Frank Wolf, MD; raneen Abu Shqara, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems