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

RecruitingPhase 4Ages 18 Years - 60 YearsFemaleHaEmek Medical Center, Israel
NCT06803992 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Dinoprostone vaginal insert
  • Dinoprostone gel and Foley catheter balloon
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Where

1 site
Emek medical center
Afula, Israel
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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