RecruitingNot ApplicableNCT05586334

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

Development and Clinical Evaluation of an Innovative Medical Device to Predict Preterm Birth: From Basic Research to Obstetric Emergencies


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

3,600 participants

Start Date

Jun 8, 2023

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

Preterm birth is a leading cause of newborn health problems. This study tests a new medical device called PrediMAP that may be able to predict whether a pregnant woman who comes to the emergency room with signs of early labor will actually deliver prematurely. Early and accurate prediction could help doctors provide better care. You may be eligible if: - You are pregnant with a live fetus - You are between 22 and 34 weeks and 6 days of pregnancy - You have come to the emergency room with signs of possible preterm labor (contractions or cervical changes) - You are 18 or older You may NOT be eligible if: - Your membranes have already ruptured prematurely - You are in active labor with imminent delivery - You are carrying three or more fetuses - You do not speak French and do not have a French-speaking companion present Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALCollection of vaginal secretions

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

BIOLOGICALCollection 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

OTHERAdministration of EPDS questionnaire

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


Locations(1)

Louis Mourier Hospital

Colombes, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05586334


Related Trials