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Development and Clinical Evaluation of an Innovative Medical Device to Predict Preterm Birth: From Basic Research to Obstetric Emergencies (PrediMAP)
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).
Details
| Lead sponsor | Assistance Publique - Hôpitaux de Paris |
|---|---|
| Phase | NA |
| Status | RECRUITING |
| Enrolment | 3600 |
| Start date | 2023-06-08 |
| Completion | 2027-12 |
Conditions
- Preterm Labor
Interventions
- Collection of vaginal secretions
- Collection of the placenta and the membranes
- Administration of EPDS questionnaire
Primary outcomes
- Delivery occurence 7 days after inclusion — Cohort 1 : assessed 15-21 days after inclusion of each patient. Cohort 3: assessed after end of follow-up (5.5 months).
Countries
France