Dinoprostone vaginal insertDinoprostone gel and Foley catheter balloon
Dinoprostone vaginal insert: Described in the arm descriptions
Dinoprostone gel and Foley catheter balloon: Described in the arm descriptions
Study 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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
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
Primary outcome measure(s)
comparing the duration of induction-to-vaginal delivery — from enrollment until final outcome - a month measuring the duration of Induction-of-labor by Propess versus the combined use of PGE2 gel and balloon catheter by induction-to-vaginal delivery interval from the beginning of the induction according to the chosen patient protocol and until vaginal delivery.
Trial sites (1)
Facility
City
Region
Status
Emek medical center
Afula
Israel
Recruiting
More HaEmek Medical Center, Israel trials in Israel
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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