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
Inclusion Criteria8
- Pregnant with live fetus(es)
- Emergency room visit between 22 and 34 days of pregnancy + 6 days
- For a suspicion of PTL defined by :
- Uterine contractions (UC) objectified during the consultation (questioning, clinical examination, external tocography),
- And/or clinical or ultrasound changes of the uterine cervix;
- OR for any other reason but with EC and/or clinical or ultrasound changes of the cervix on clinical examination
- Social security coverage or AME: patients receiving AME are at higher risk of PAD and preterm delivery.
- Signature of consent
Exclusion Criteria7
- Age \< 18 years;
- Premature rupture of membranes
- Patient in labor with imminent delivery.
- Total absence of social care
- Minor or protected adult (guardianship or curatorship)
- Persons who do not speak French and not accompanied by a French-speaking third party
- Multiple pregnancy \>= 3
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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