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
This trial does not accept healthy volunteersQualifiers
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
Single group
Treatments tested in this trial
Collection of vaginal secretions
Biological/VaccineIn all women included: Vaginal secretion sampling at the time of the obstetrical emergency consultation.
Collection of the placenta and the membranes
Biological/VaccineIn cohort 1, for 30 patients at the Port Royal Maternity Hospital, the placenta and membranes will be collected after delivery
Administration of EPDS questionnaire
Other interventionIn cohort 3, the EPDS questionnaire will be administered to all participants after the consultation in the emergency department.
Treatment groups
Trial outcomes
Primary outcomes
Delivery occurence 7 days after inclusion
Secondary outcomes
delivery occurrence 14 days after consultation
delivery <32 weeks of gestation, <34 weeks and <37 weeks
Gestational age at delivery, in 4 categories.
neonatal mortality;
severe neonatal morbidity
Defined by one or more of the following : * Bronchopumonary dyplasia * Necrotizing enterocolitis stage 2 or 3 * Intraventricular haemorrhage stage 3-4 * Periventricular leukomalacia * Retinopathy of prematurity stage \>3
Sponsors and contacts
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Assistance Publique - Hôpitaux de Paris
Lead sponsor
URC-CIC Paris Descartes Necker Cochin
Collaborator