IV PAPAVERINE Prior to Propess for Labor Induction

NCT06550232 | Completed Phase 4

• 1 other identifier: 0112-24-NHR
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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

Conditions

Induced Vaginal Delivery

Keywords

labor induction; papaverine; propess; bishop score; induction to delivery interval

Outcome Measures

Primary Outcomes (2)

• Delta Bishop score

  The bishop score before and after propess insertion

  24 hours

• the time from propess insertion until delivery

  induction to delivery time

  72 hours

Secondary Outcomes (2)

• maternal satisfaction scores

  24 hours

• visual analogue scale score

  24 hours

Study Arms (2)

papaverine arm

ACTIVE COMPARATOR

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

Drug: Papaverine

Control arm

PLACEBO COMPARATOR

I.V 100 ml 0.9% saline

Other: placebo

Interventions

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

papaverine arm

placebo OTHER

I.V Sallne

Control arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Western Galilee Hospital-Nahariya: lead

Study Sites (1)

Galilee Medical Center

Nahariya, Israel

Location

Related Publications (6)

• Oliveira MV, Oberst PV, Leite GK, Aguemi A, Kenj G, Leme VD, Sass N. [Cervical Foley catheter versus vaginal misoprostol for cervical ripening and induction of labor: a randomized clinical trial]. Rev Bras Ginecol Obstet. 2010 Jul;32(7):346-51. doi: 10.1590/s0100-72032010000700007. Portuguese.

  PMID: 21152844 BACKGROUND

• Rohwer AC, Khondowe O, Young T. Antispasmodics for labour. Cochrane Database Syst Rev. 2012 Aug 15;(8):CD009243. doi: 10.1002/14651858.CD009243.pub2.

  PMID: 22895986 BACKGROUND

• Singh KC, Jain P, Goel N, Saxena A. Drotaverine hydrochloride for augmentation of labor. Int J Gynaecol Obstet. 2004 Jan;84(1):17-22. doi: 10.1016/s0020-7292(03)00276-5.

  PMID: 14698825 BACKGROUND

• Ibrahim MI, Alzeeniny HA, Ellaithy MI, Salama AH, Abdellatif MA. Drotaverine to improve progression of labor among nulliparous women. Int J Gynaecol Obstet. 2014 Feb;124(2):112-7. doi: 10.1016/j.ijgo.2013.08.013. Epub 2013 Nov 7.

  PMID: 24299975 BACKGROUND

• Madhu C, Mahavarkar S, Bhave S. A randomised controlled study comparing Drotaverine hydrochloride and Valethamate bromide in the augmentation of labour. Arch Gynecol Obstet. 2010 Jul;282(1):11-5. doi: 10.1007/s00404-009-1188-8. Epub 2009 Jul 31.

  PMID: 19644697 BACKGROUND

• Yilmaz B, Kart C, Kelekci S, Gokturk U, Sut N, Tarlan N, Mollamahmutoglu L. Meperidine versus valethamate bromide in shortening the duration of active labor. Int J Gynaecol Obstet. 2009 Nov;107(2):126-9. doi: 10.1016/j.ijgo.2009.06.021. Epub 2009 Aug 6.

  PMID: 19664769 BACKGROUND

MeSH Terms

Interventions

Papaverine

Intervention Hierarchy (Ancestors)

Benzylisoquinolines; Alkaloids; Heterocyclic Compounds; Opiate Alkaloids; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The group allocation will be double blind. The randomization table will be available only to one member of the study, who will prepare the medications according to the allocated intervention. Participants will receive intravenous 0.9% normal saline with or without papaverine. The same bottles of normal saline will be use for the papaverine and placebo groups. Accordingly, the participants will be masked for the intervention. The participants, the researchers including the obstetricians who inserted the PGE2 (propess), the caregiver nurse who administrated the medication, the data collector, and the statistician will be blinded to the group allocations throughout the study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Fetal Maternal Unit

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 12, 2024
• Study Start: August 12, 2024
• Primary Completion: March 23, 2025
• Study Completion: March 23, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR

Locations

IL (1)