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

RecruitingNAAges 18 Years - anyFemaleAssistance Publique - Hôpitaux de Paris
NCT05586334 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
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
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What it tests

  • Collection of vaginal secretions
  • Collection of the placenta and the membranes
  • Administration of EPDS questionnaire
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Where

1 site
Louis Mourier Hospital
Colombes, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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