Induction of Labor - Comparison Propess With Prostaglandin E2 Vaginal Gel and Balloon Catheter
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dinoprostone vaginal insert, Dinoprostone gel and Foley catheter balloon.
- Who it may be relevant to
- Registry conditions: Induction of Labor. Basic parameters: 18 years — 60 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Induction of Labor in Women With Unfavorable Cervix at Term - Comparison of Propess Versus Prostaglandin E2 Vaginal Gel and Extra-amniotic Balloon Catheter
Overview
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.
Interventions
- Drug Dinoprostone vaginal insert
Described in the arm descriptions - Combination product Dinoprostone gel and Foley catheter balloon
Described in the arm descriptions
Primary outcome measures
- comparing the duration of induction-to-vaginal delivery [Time frame: from enrollment until final outcome - a month]
Secondary outcome measures (4)
- rate of vaginal delivery in 24 and 48 hours from IOL [Time frame: from enrollment until final outcome - a month]
- Number of Participants with Treatment-Related Adverse Events [Time frame: from enrollment until final outcome - a month]
- rate of Induction success [Time frame: from enrollment until final outcome - a month]
- rate o Cervical ripening success [Time frame: from enrollment until final outcome - a month]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Israel · 1 center
- Emek medical center — Afula
Identifiers
NCT: NCT06803992 · 79-23