Prediction of Labor Induction Outcome in Nulliparous Women

Nulliparous Patient With Unfavourable Cervix, Undergoing Labor Induction at Term ≥ 39SA

Pregnancy, Childbirth, Induction of labor, Biomarkers

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.

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. The predictive value of the three biomarkers will be assessed in the same manner for the following secondary outcomes: the rate of vaginal delivery within 24 hours of induction onset, the time from induction onset to delivery, and the time from induction onset to reaching 6 cm of cervical dilation. In addition, patients will be offered the option of donating a sample of the placenta and fetal membranes (amniotic sac) following delivery. These tissues, which are not routinely preserved, will be analyzed with the aim of identifying potential new biomarkers of interest. The collection of a placental sample at delivery is not a prerequisite for participation in the study. Patients will be free to participate in the study (i.e. biomarker measurement in vaginal secretions) while objecting to the collection of a placental sample at delivery.

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