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Development and Clinical Evaluation of an Innovative Medical Device to Predict Preterm Birth (PrediMAP)
Sponsor: Assistance Publique - Hôpitaux de Paris
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).
Official title: Development and Clinical Evaluation of an Innovative Medical Device to Predict Preterm Birth: From Basic Research to Obstetric Emergencies
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
3600
Start Date
2023-06-08
Completion Date
2027-12
Last Updated
2025-11-20
Healthy Volunteers
No
Conditions
Interventions
Collection of vaginal secretions
In all women included: Vaginal secretion sampling at the time of the obstetrical emergency consultation.
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
Administration 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