Actively Recruiting
Induction of Labor - Comparison Propess With Prostaglandin E2 Vaginal Gel and Balloon Catheter
Led by HaEmek Medical Center, Israel · Updated on 2025-12-01
140
Participants Needed
1
Research Sites
94 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Induction of Labor - Comparison Propess With Prostaglandin E2 Vaginal Gel and Balloon Catheter
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women at term (37 weeks of gestation or more) with a single baby
- Intended for labor induction
- Initial Bishop score less than 5
- No contraindications to receive either treatment
- Women willing to give informed consent
- Women aged 18 years or older
You will not qualify if you...
- Known allergy or contraindications to Propess or prostaglandin E2
- Five or more previous births (parity 5 or more)
- Labor contractions more than 4 in 20 minutes
- Glaucoma
- History of previous uterine surgery
- Vaginal delivery contraindicated
- Active heart, kidney, lung, or liver disease
- Severe asthma or lung disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Emek medical center
Afula, Israel
Actively Recruiting
Research Team
Z
Zohar Nachum, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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