Induction of Labor - Comparison Propess With Prostaglandin E2 Vaginal Gel and Balloon Catheter (NCT06803992) | Clinical Trial Compass
RecruitingPhase 4
Induction of Labor - Comparison Propess With Prostaglandin E2 Vaginal Gel and Balloon Catheter
Israel140 participantsStarted 2025-04-06
Plain-language 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.
Who can participate
Age range
18 Years – 60 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
comparing the duration of induction-to-vaginal delivery
Timeframe: from enrollment until final outcome - a month