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Development and Clinical Evaluation of an Innovative Medical Device to Predict Preterm Birth (PrediMAP)

NCT05586334 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3600

Last updated 2025-11-20

No results posted yet for this study

Summary

The purpose of this study is to clinically validate the predictive performance (sensitivity and specificity) of the PrediMAP in-vitro diagnostic medical device to predict delivery within 7 days in the target population of women consulting obstetric emergencies for preterm labor (PTL).

Conditions

  • Preterm Labor

Interventions

OTHER

Administration of EPDS questionnaire

In cohort 3, the EPDS questionnaire will be administered to all participants after the consultation in the emergency department.

BIOLOGICAL

Collection of vaginal secretions

In all women included: Vaginal secretion sampling at the time of the obstetrical emergency consultation.

BIOLOGICAL

Collection of the placenta and the membranes

In cohort 1, for 30 patients at the Port Royal Maternity Hospital, the placenta and membranes will be collected after delivery

Sponsors & Collaborators

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Jeanne SIBIUDE, MD, PhD · APHP

  • François GOFFINET, Pr · APHP

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-08
Primary Completion
2027-06-30
Completion
2027-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05586334 on ClinicalTrials.gov