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NCT Number: NCT06803992

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

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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Key information

Conditions

Induction of Labor

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Emek medical center

Afula, Israel

Location status: Recruiting

Location contact

Zohar Nachum

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dinoprostone vaginal insert

Drug

Described in the arm descriptions

Other names: Propess

Dinoprostone gel and Foley catheter balloon

Combination Product

Described in the arm descriptions

Primary outcomes

  1. comparing the duration of induction-to-vaginal delivery

    Time frame: 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.

Secondary outcomes

  1. rate of vaginal delivery in 24 and 48 hours from IOL

    Time frame: from enrollment until final outcome - a month

    the number of participants who had vaginal delivery in 24 and 48 hours from the beginning of the induction-of-labor for both protocols

  2. Number of Participants with Treatment-Related Adverse Events

    Time frame: from enrollment until final outcome - a month

    Maternal -gathering the numbers of participants who had adverse events such as chorioamnionitis, endometritis, postpartum hemorrhage, uterine rupture, Neonatal -gathering the numbers of participants who had adverse events such as uterine hypertonia (contractions exceeding more than two minutes in duration) and/or tachysystole (more than 5 contractions in 10 minutes, averaged over a 30-minute period) with and without decelerations, non-reassuring fetal heart rate according to fetal monitoring, meconium-stained amniotic liquor, umbilical artery pH less than 7.1, Apgar score less than 7 at 5 min, postpartum transfer to neonatal intensive care unit, infection of the newborn

  3. rate of Induction success

    Time frame: from enrollment until final outcome - a month

    the number of participants who had ceasarean section

  4. rate o Cervical ripening success

    Time frame: from enrollment until final outcome - a month

    the duration from the beginning of the induction to bishop score 5

Study contacts

Contact information is provided by the study sponsor or research team.

Zohar Nachum, Professor

CONTACT

[email protected]

+972547696562

Sponsors and collaborators

Lead sponsor

HaEmek Medical Center, Israel

Other

Registry information

Official study title

Induction of Labor in Women With Unfavorable Cervix at Term - Comparison of Propess Versus Prostaglandin E2 Vaginal Gel and Extra-amniotic Balloon Catheter

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 31, 2025
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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