Clinical Trial

Prediction of Labor Induction Outcome in Nulliparous Women

Study acronym: PREDISS
Not Yet Recruiting
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Summary
Labor induction rates are increasing worldwide, yet nulliparous patients remain at high risk of failed induction and intrapartum cesarean delivery as well as prolonged labor which are associated with increased maternal morbidity, adverse outcomes in future pregnancies, increased neonatal morbidity and negative childbirth experience. This study aims to evaluate whether macrophage activation biomarkers in cervicovaginal secretions can predict successful labor induction in low-risk nulliparous women at term with an unfavorable cervix (Bishop score \<6). The study focuses on three patented biomarkers of "imminence of delivery" (MCP1, CD14, and CD163), previously shown to be markedly elevated during spontaneous labor. We hypothesize that higher biomarker concentrations reflect biological readiness for labor and are associated with successful induction, defined as entry into the active phase of labor (cervical dilation ≥6 cm). Secondary objectives include evaluating the association between biomarker concentrations and labor progression. Identifying reliable predictive biomarkers could improve patient selection for induction and optimize obstetrical management in nulliparous women.
Trial Details
NCT Number NCT07637318
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators: URC-CIC Paris Descartes Necker Cochin
Conditions Nulliparous Patient With Unfavourable Cervix, Undergoing Labor Induction at Term ≥ 39SA
Enrollment 190 participants
Start Date 2026-06
Primary Completion 2027-07 (estimated)
Study Completion 2028-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-09