Development and Clinical Evaluation of an Innovative Medical Device to Predict Preterm Birth (PrediMAP)
Recruiting
N/A
Interventional Study
Preterm Labor
At a Glance
- Age
- 18 and older
- Sex
- Female
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 3,600 (estimated)
- Sponsor
- Assistance Publique - Hôpitaux de Paris · Other
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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).
Trial Locations
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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 clinic…
Contacts