Propess versus PGE2 gel plus Foley balloon for cervical ripening before labor
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
Run by HaEmek Medical Center, Israel · NCT06803992 · Data updated 2026-11-12
This trial tests whether a slow‑release Propess insert or a PGE2 vaginal gel combined with a Foley balloon gets women at term with a single baby and an unfavorable cervix into active labor faster.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 60 Years |
| Sex | Women only |
| Enrollment | 140 (estimated) |
| Sponsor | HaEmek Medical Center, Israel Academic / other |
| Locations | 1 site (Afula) |
| Status | Recruiting |
| Started | April 6, 2025 |
| Main results expected | January 29, 2027 |
| Study ends | January 29, 2027 |
| Registry record updated | December 1, 2025 |
| Trial ID | NCT06803992 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 18 or older at ≥37 weeks gestation with a single fetus, an initial Bishop score below 5, a plan for induction of labor, and no contraindications to prostaglandins or vaginal delivery.
✕Probably not a fit
Patients with contraindications to prostaglandins, prior uterine surgery, active frequent contractions, severe cardiorespiratory/hepatic/renal disease, or other conditions that make vaginal delivery unsafe are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, phase 4, single‑center trial at HaEmek Medical Center comparing two cervical ripening approaches for term, singleton pregnancies with an unfavorable cervix (Bishop score <5). One arm receives a 10 mg slow‑release dinoprostone (Propess) vaginal insert and the other receives dinoprostone vaginal gel (1–2 mg) combined with a Foley catheter balloon. The primary outcome is time from the start of induction to delivery, with safety monitoring for maternal and fetal complications. Eligible participants are women ≥37 weeks with singleton pregnancies planned for induction and without contraindications to prostaglandins or vaginal delivery.
Why it matters
Potential benefit: If successful, the preferred method could shorten time to delivery and reduce additional interventions or complications associated with prolonged induction.
How similar studies have gone: Both prostaglandin preparations and Foley balloon catheters are established cervical ripening methods with mixed comparative results, but direct comparison of Propess versus PGE2 gel combined with a Foley catheter has not been previously studied.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Emek medical center
Afula, Israel Recruiting
Study contacts
- Study coordinator: Zohar Nachum, Professor
- Email: nachum.zo@gmail.com
- Phone: +972547696562
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Ophthalmic Artery Doppler to predict labor problems before induction
This study tests whether measuring the ophthalmic artery Doppler in pregnant people at term who are being induced can help predict intrapartum fetal distress.
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Natural cervical ripening to delay pharmacological induction of labor
This pilot study tests whether nipple stimulation and membrane sweeping can help some pregnant people go into labor on their own without needing drugs.
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Using castor oil and a balloon catheter to induce labor in multiparous women
This study is testing if taking castor oil with orange juice along with a balloon catheter can help women who have given birth before have their babies faster and easier.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.