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Completed

NCT Number: NCT06550232

IV PAPAVERINE Prior to Propess for Labor Induction

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

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Key information

Conditions

Induced Vaginal Delivery

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Galilee Medical Center

Nahariya, Israel

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Papaverine

Drug

Within 30-minutes prior to catheter insertion, women in the intervention group will receive IV-papaverine 80 mg in 100 ml 0.9% saline

Placebo

Other

I.V Sallne

Primary outcomes

  1. Delta Bishop score

    Time frame: 24 hours

    The bishop score before and after propess insertion

  2. the time from propess insertion until delivery

    Time frame: 72 hours

    induction to delivery time

Secondary outcomes

  1. maternal satisfaction scores

    Time frame: 24 hours

    maternal satisfaction on 1-5 scale. higher scores mean higher satisfaction

  2. visual analogue scale score

    Time frame: 24 hours

    pain assessment using a 10-point visual analogue scale

Sponsors and collaborators

Lead sponsor

Western Galilee Hospital-Nahariya

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 12, 2024
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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