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
Assistance Publique - Hôpitaux de Paris
3,600 participants
Jun 8, 2023
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
Plain Language Summary
Simplified for easier understanding
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.
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Interventions
In all women included: Vaginal secretion sampling at the time of the obstetrical emergency consultation.
In cohort 1, for 30 patients at the Port Royal Maternity Hospital, the placenta and membranes will be collected after delivery
In cohort 3, the EPDS questionnaire will be administered to all participants after the consultation in the emergency department.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05586334