Induction of Labor - Comparison Propess With Prostaglandin E2 Vaginal Gel and Balloon Catheter

NCT06803992 | Recruiting Phase 4 DMC

• 1 other identifier: 79-23
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

One of every four births in the Western world is induced, usually due to the risk of maternal and fetal morbidity. There are several methods of labor induction, pharmacological and mechanical. In cases of unfavorable cervix (Bishop score is below 5), cervical ripening can be induced by either prostaglandins E2 (slow release 10 mg dinoprostone insert (propess) or vaginal gel 1-2 mg) or mechanically by Foley catheter balloon (FCB). The efficacy of labor induction of propess versus vaginal gel combined with FCB was not studied previously. The goal of this randomized controlled trial is to compare the efficacy of propess versus PGE2 vaginal gel combined with FCB in women with singletons undergoing labor induction at term. The main question it aims to answer is to compare the time from the beginning of labor induction until delivery.

Conditions

Induction of Labor

Outcome Measures

Primary Outcomes (1)

• comparing the duration of induction-to-vaginal delivery

  measuring the duration of Induction-of-labor by Propess versus the combined use of PGE2 gel and balloon catheter by induction-to-vaginal delivery interval from the beginning of the induction according to the chosen patient protocol and until vaginal delivery.

  from enrollment until final outcome - a month

Secondary Outcomes (4)

• rate of vaginal delivery in 24 and 48 hours from IOL

  from enrollment until final outcome - a month

• Number of Participants with Treatment-Related Adverse Events

  from enrollment until final outcome - a month

• rate of Induction success

  from enrollment until final outcome - a month

• rate o Cervical ripening success

  from enrollment until final outcome - a month

Study Arms (2)

Propess pessary

EXPERIMENTAL

Placement of a slow-release 10 mg dinoprostone insert (propess) in the posterior fornix for up to 24 hours until labor initiation or favorable cervix, followed by amniotomy and oxytocin administration. In a case of failure, induction of labor will be done with either PGE2 gel and/or Foley catheter.

Drug: Dinoprostone vaginal insert

Sequential PGE2 vaginal gel and Foley catheter balloon

EXPERIMENTAL

Insertion of 1 mg dinoprostone (PGE2) vaginal gel to the posterior fornix with reassessment up to 6 hours later. If the Bishop score is still less than 5 and there are no more than 4 contractions in 20 minutes of monitoring, an additional PGE2 vaginal gel of 2 mg is inserted. If there are more than 4 contractions in 20 minutes of monitoring or if after up to 6 hours there will be low Bishop score, a 60 ml Foley catheter balloon is placed for 6 to 12 hours or until spontaneous expulsion. When the cervix is favorable, amniotomy and oxytocin administration are followed. In a case of a failure, induction of labor with Propess will be conducted.

Combination Product: Dinoprostone gel and Foley catheter balloon

Interventions

Dinoprostone vaginal insert DRUG

Described in the arm descriptions

Also known as: Propess

Propess pessary

Dinoprostone gel and Foley catheter balloon COMBINATION_PRODUCT

Described in the arm descriptions

Sequential PGE2 vaginal gel and Foley catheter balloon

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women at term (37 weeks of gestation or more) with singleton
• pregnancies that are intended for IOL.
• Initial bishop score \<5
• No contraindications to receive either treatment.
• Women who will give informed consent to be included in the study.
• Women at or over the age of 18.

You may not qualify if:

• Women with a known hypersensitivity or contraindications to Propess / PGE2.
• Parity 5 or more
• Labor contractions more than 4 in 20 min
• Glaucoma
• History of previous uterine surgery
• Hypersensitivity to prostaglandins
• Vaginal delivery is contraindicated
• Active cardiac, renal, pulmonary, or hepatic disease
• Severe asthma or pulmonary disease

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (1)

Emek medical center

Afula, Israel

RECRUITING

Study Officials

• Zohar Nachum, Professor

  Emek Medical Center

  STUDY DIRECTOR

Central Study Contacts

Zohar Nachum, Professor

CONTACT

+972547696562; nachum.zo@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: January 19, 2025
• First Posted: January 31, 2025
• Study Start: April 6, 2025
• Primary Completion (Estimated): January 29, 2027
• Study Completion (Estimated): January 29, 2027
• Last Updated: December 1, 2025

Record last verified: 2025-01

Locations

IL (1)