Clinical trial
Development and Clinical Evaluation of an Innovative Medical Device to Predict Preterm Birth: From Basic Research to Obstetric Emergencies
Name
APHP220187
Description
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).
Trial arms
Trial start
2023-06-08
Estimated PCD
2027-06-01
Trial end
2027-12-01
Status
Recruiting
Treatment
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.
Size
3600
Primary endpoint
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).
Eligibility criteria
Inclusion Criteria:
* 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 Criteria
* 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'lack of result reporting', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 3600, 'type': 'ESTIMATED'}}
Updated at
2024-01-10
1 organization
2 products
1 indication
Organization
Assistance Publique - Hôpitaux de ParisIndication
Preterm Labour