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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-60
SponsorHaEmek Medical Center, Israel

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

Women with a known hypersensitivity or contraindications to Propess / PGE2.

Parity 5 or more

Labor contractions more than 4 in 20 min

Glaucoma

Trial design

Treatments tested in this trial

  • Dinoprostone vaginal insert
  • Dinoprostone gel and Foley catheter balloon

Treatment groups

140 Participants
are divided into 2 treatment groups

Sponsors and collaborators