About this trial
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 criteria
Qualifiers
Pregnant with live fetus(es)
Emergency room visit between 22 and 34 days of pregnancy + 6 days
Uterine contractions (UC) objectified during the consultation (questioning, clinical examination, external tocography),
And/or clinical or ultrasound changes of the uterine cervix;
Disqualifiers
Age < 18 years;
Premature rupture of membranes
Patient in labor with imminent delivery.
Total absence of social care
Trial design
Treatments tested in this trial
- Collection of vaginal secretions
- Collection of the placenta and the membranes
- Administration of EPDS questionnaire
Treatment groups
Sponsors and collaborators
Assistance Publique - Hôpitaux de Paris
Lead sponsor
URC-CIC Paris Descartes Necker Cochin
Collaborator