Evaluation of Biomarkers in Term Labor Induction in Low-Risk Nulliparous Patients: Toward Better Prediction of Induction Outcomes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 190
- Locations
- 1
- Primary Endpoint
- The primary outcome is successful labor induction, defined as entry into the active phase of labor (cervical dilation ≥6 cm).
Study Overview
Brief 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.
Detailed Description
The aim of labor induction is to reduce maternal and/or fetal complications associated with continuation of pregnancy while enabling vaginal delivery.
The investigators hypothesize that, at the time of induction, some key biological changes may already have occurred, thereby facilitating the initiation and progression of labor.
Our objective is to evaluate the association between the concentration of three macrophage activation biomarkers (referred to as "imminence of delivery" biomarkers) in cervicovaginal secretions (MCP1, CD14, and CD163) and successful labor induction among low-risk nulliparous women with an unfavorable cervix (Bishop score <6) at ≥39 weeks of gestation. We hypothesize that high biomarker concentrations will predict successful induction.
Pregnant women ≥ 39 weeks of gestation admitted to the maternity unit for labor induction who are eligible for the study will be approached to participate. The study procedures will be explained by the clinician (obstetrician-gynaecologist or midwife) in charge of the patient. In the absence of objection, the clinician who provided the information will complete the non-opposition form required for the patient's inclusion in the study. A cervicovaginal swab for biomarker measurement will be collected prior to labor induction.
A non-parametric Kruskal-Wallis test will be used to compare biomarker concentrations between patients who underwent caesarean delivery before 6 cm of cervical dilation and those whose labor progressed beyond 6 cm. The predictive value of biomarkers for induction success will be assessed using receiver operating characteristic (ROC) curves. The area under the curve (AUC) will be calculated with its 95% confidence interval, and the optimal threshold for each biomarker will be determined.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Nulliparous patients
In low-risk nulliparous patients with unfavourable cervix undergoing labor induction ≥39SA
Intervention: Vaginal sample (Biological)
Outcomes
Primary Outcomes
The primary outcome is successful labor induction, defined as entry into the active phase of labor (cervical dilation ≥6 cm).
Time Frame: Up to 7 days
Secondary Outcomes
- The rate of vaginal delivery within 24 hours of the start of induction(Within 24hours of the start of induction)
- The time from the beginning of labour induction to vaginal delivery (in hours)(From the beginning of labour induction to vaginal delivery (in hours))
- The time from the beginning of labour induction to 6 cm of dilation (entry into the active phase) (in hours)(From the beginning of labour induction to 6 cm of dilation)