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

Preterm Labor

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

This clinical trial is studying Administration of EPDS questionnaire, a biological treatment called Collection of the placenta and the membranes, and others for people with preterm labor. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 18 Years and older.

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

Uterine Artery Doppler Indices and Uterocervical Angle Measurment in Prediction of Preterm Labor

NCT073361731 location

The Combined Effect of Magnesium, Palmitoylethanolamide, High-Molecular-weight Hyaluronic Acid, Vitamin B6, and Vitamin D in Preventing Preterm Birth:

NCT073055191 location