Development and Clinical Evaluation of an Innovative Medical Device to Predict Preterm Birth (PrediMAP)

Recruiting now · Not applicable

Conditions studied: Preterm Labor

In brief

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).

Key facts

Study ID

NCT05586334

Run by

Assistance Publique - Hôpitaux de Paris

People needed

3600

Starts

2023-06-08

Expected to finish

2027-12-01

Last updated by the study team

2025-11-20

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Louis Mourier Hospital — Colombes, France (enrolling)

Full record on ClinicalTrials.gov

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