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

Induction of Labor in Women With Unfavorable Cervix at Term - Comparison of Propess Versus Prostaglandin E2 Vaginal Gel and Extra-amniotic Balloon Catheter

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.

Study Overview

• Status: Recruiting
• Conditions: Induction of Labor
• Intervention / Treatment: Drug: Dinoprostone vaginal insert; Combination product: Dinoprostone gel and Foley catheter balloon

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Zohar Nachum, Professor; Phone Number: +972547696562; Email: nachum.zo@gmail.com

Study Locations

• Israel
  • Afula, Israel
    • Recruiting
    • Emek Medical Center
    • Contact: Zohar Nachum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Propess pessary; 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; Described in the arm descriptions; Other Names: Propess
Experimental: Sequential PGE2 vaginal gel and Foley catheter balloon; 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; Described in the arm descriptions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of vaginal delivery in 24 and 48 hours from IOL	the number of participants who had vaginal delivery in 24 and 48 hours from the beginning of the induction-of-labor for both protocols	from enrollment until final outcome - a month
Number of Participants with Treatment-Related Adverse Events	Maternal -gathering the numbers of participants who had adverse events such as chorioamnionitis, endometritis, postpartum hemorrhage, uterine rupture, Neonatal -gathering the numbers of participants who had adverse events such as uterine hypertonia (contractions exceeding more than two minutes in duration) and/or tachysystole (more than 5 contractions in 10 minutes, averaged over a 30-minute period) with and without decelerations, non-reassuring fetal heart rate according to fetal monitoring, meconium-stained amniotic liquor, umbilical artery pH less than 7.1, Apgar score less than 7 at 5 min, postpartum transfer to neonatal intensive care unit, infection of the newborn	from enrollment until final outcome - a month
rate of Induction success	the number of participants who had ceasarean section	from enrollment until final outcome - a month
rate o Cervical ripening success	the duration from the beginning of the induction to bishop score 5	from enrollment until final outcome - a month

Collaborators and Investigators

• Sponsor: HaEmek Medical Center, Israel
• Investigators: Study Director: Zohar Nachum, Professor, Emek Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2025
• Primary Completion (Estimated): January 29, 2027
• Study Completion (Estimated): January 29, 2027

Study Registration Dates

• First Submitted: January 19, 2025
• First Submitted That Met QC Criteria: January 28, 2025
• First Posted (Actual): January 31, 2025

Study Record Updates

• Last Update Posted (Actual): December 1, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Dinoprostone
• Other Study ID Numbers: 79-23

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes