AP-HP - Hôpital Cochin - Maternité Port-Royal
Paris, Île-de-France Region, 75014, France
Not Yet Recruiting
NCT Number: NCT07637318
Prediction of Labor Induction Outcome in Nulliparous Women
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.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Age range
18 year and older
Sex eligibility
Female
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Vaginal sample
BiologicalA vaginal sample will be collected from 39 weeks of gestation onward, prior to labor induction. The vaginal swab for biomarker testing will be collected at the same time as the vaginal swab for Group B streptococcus screening (which is routinely performed as part of standard care, in accordance with clinical practice guidelines). Therefore, no additional procedure is required for this research.
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
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The rate of vaginal delivery within 24 hours of the start of induction
Time frame: Within 24hours of the start of induction
-
The time from the beginning of labour induction to vaginal delivery (in hours)
Time frame: 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)
Time frame: From the beginning of labour induction to 6 cm of dilation
Study contacts
Contact information is provided by the study sponsor or research team.
Christelle AUGER
CONTACT
01 71 76 07 53 ext. +33
Maëlys NKOBETCHOU, Medical Degree
CONTACT
01 58 41 38 18 ext. +33
Sponsors and collaborators
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Other
Collaborators
- URC-CIC Paris Descartes Necker Cochin
Registry information
Official study title
Evaluation of Biomarkers in Term Labor Induction in Low-Risk Nulliparous Patients: Toward Better Prediction of Induction Outcomes
Acronym: PREDISS
Important dates
- Study start
- 2026
- Primary completion
- 2027
- Study completion
- 2028
- First posted
- Jun 9, 2026
- Registry last updated
- Jul 20, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.