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

Phase 4

Not yet recruiting

• Conditions: Induction of Labor
• Interventions: Drug: Dinoprostone vaginal insert; Combination Product: Dinoprostone gel and Foley catheter balloon

• Registration Number: NCT06803992
• Lead Sponsor: HaEmek Medical Center, Israel

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-19
• Study First Submitted QC: 2025-01-28
• Last Update Submitted: 2025-01-28
• Study Start: 2025-01-29
• Study First Posted: 2025-01-31
• Last Update Posted: 2025-01-31
• Primary Completion: 2027-01-29
• Study Completion: 2027-01-29

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propess pessary	Dinoprostone vaginal insert	Placement of a slow-release 10 mg dinoprostone insert (propess) in the posterior fornix for up to 24 hours until labor initiation or favorable cervix, followed by amniotomy and oxytocin administration. In a case of failure, induction of labor will be done with either PGE2 gel and/or Foley catheter.
Sequential PGE2 vaginal gel and Foley catheter balloon	Dinoprostone gel and Foley catheter balloon	Insertion of 1 mg dinoprostone (PGE2) vaginal gel to the posterior fornix with reassessment up to 6 hours later. If the Bishop score is still less than 5 and there are no more than 4 contractions in 20 minutes of monitoring, an additional PGE2 vaginal gel of 2 mg is inserted. If there are more than 4 contractions in 20 minutes of monitoring or if after up to 6 hours there will be low Bishop score, a 60 ml Foley catheter balloon is placed for 6 to 12 hours or until spontaneous expulsion. When the cervix is favorable, amniotomy and oxytocin administration are followed. In a case of a failure, induction of labor with Propess will be conducted.

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
rate of vaginal delivery in 24 and 48 hours from IOL	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
Number of Participants with Treatment-Related Adverse Events	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
rate of Induction success	from enrollment until final outcome - a month	the number of participants who had ceasarean section
rate o Cervical ripening success	from enrollment until final outcome - a month	the duration from the beginning of the induction to bishop score 5

Trial Locations

Locations (1)

Emek medical center; 🇮🇱 Afula, Israel