Prediction of Labor Induction Outcome in Nulliparous Women (PREDISS)

July 17, 2026 updated by: Assistance Publique - Hôpitaux de Paris

Evaluation of Biomarkers in Term Labor Induction in Low-Risk Nulliparous Patients: Toward Better Prediction of Induction Outcomes

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

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.

Study Type

Observational

Enrollment (Estimated)

190

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Île-de-France Region
      • Paris, Île-de-France Region, France, 75014
        • AP-HP - Hôpital Cochin - Maternité Port-Royal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Nulliparous patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Nulliparous patients
In low-risk nulliparous patients with unfavourable cervix undergoing labor induction ≥39SA
Biological: Vaginal sample
A 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Up to 7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
The rate of vaginal delivery within 24 hours of the start of induction
Time Frame: Within 24hours 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)
Time Frame: 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)
Time Frame: From the beginning of labour induction to 6 cm of dilation
From the beginning of labour induction to 6 cm of dilation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

URC-CIC Paris Descartes Necker Cochin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

May 18, 2026

First Submitted That Met QC Criteria

June 4, 2026

First Posted (Actual)

June 9, 2026

Study Record Updates

Last Update Posted (Actual)

July 20, 2026

Last Update Submitted That Met QC Criteria

July 17, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • APHP251724
  • IDRCB (Other Identifier: 2025-A02589-40)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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