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

NCT ID: NCT06803992

Last Updated: 2025-01-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-29
• Study Completion Date: 2027-01-29

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Dinoprostone vaginal insert

Intervention Type: DRUG

Described in the arm descriptions

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.

Group Type: EXPERIMENTAL

Dinoprostone gel and Foley catheter balloon

Intervention Type: COMBINATION_PRODUCT

Described in the arm descriptions

Interventions

Dinoprostone vaginal insert

Described in the arm descriptions

Intervention Type: DRUG

Dinoprostone gel and Foley catheter balloon

Described in the arm descriptions

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

Propess

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

HaEmek Medical Center, Israel

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zohar Nachum, Professor

Role: STUDY_DIRECTOR

Emek Medical Center

Locations

Emek medical center

Afula, , Israel

Countries

Israel

Central Contacts

Zohar Nachum, Professor

Role: CONTACT

Phone: +972547696562

Email: nachum.zo@gmail.com

Other Identifiers

79-23

Identifier Type: -

Identifier Source: org_study_id