Prediction of Labor Induction Outcome in Nulliparous Women
Starting soon
Conditions studied: Nulliparous Patient With Unfavourable Cervix, Undergoing Labor Induction at Term ≥ 39SA
In brief
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.
Key facts
- Study ID
- NCT07637318
- Run by
- Assistance Publique - Hôpitaux de Paris
- People needed
- 190
- Starts
- 2026-06-01
- Expected to finish
- 2028-01-01
- Last updated by the study team
- 2026-07-20
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 18 years
- Singleton pregnancy
- Gestational age ≥ 39 weeks
- Nulliparous
- Live foetus
- Cephalic presentation
- Intact membranes
- Bishop score < 6
- Willing to participate in the study
You may not qualify if…
- A minor or a protected adult (under guardianship or conservatorship)
- Individuals who don't speak French or are not accompanied by a third party who speaks French
- Suspected intrauterine fetal growth restriction (estimated fetal weight < 3rd percentile or < 10th percentile with abnormal fetal Doppler)
- Presence of fetal malformations and/or genetic or chromosomal abnormalities
Where it is running
- AP-HP - Hôpital Cochin - Maternité Port-Royal — Paris, Île-de-France Region, France
Full record on ClinicalTrials.gov
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