Propess versus PGE2 gel plus Foley balloon for cervical ripening before labor
Induction of Labor in Women With Unfavorable Cervix at Term - Comparison of Propess Versus Prostaglandin E2 Vaginal Gel and Extra-amniotic Balloon Catheter
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 |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | Female |
| Sponsor | HaEmek Medical Center, Israel Academic / other |
| Locations | 1 site (Afula) |
| Trial ID | NCT06803992 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Afula
- Emek medical center — Afula, Israel (Recruiting)
Study contacts
- Study coordinator: Zohar Nachum, Professor
- Email: nachum.zo@gmail.com
- Phone: +972547696562
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.