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

ConditionPreterm Labor
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

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).

Eligibility criteria

Qualifiers

Pregnant with live fetus(es)

Emergency room visit between 22 and 34 days of pregnancy + 6 days

Uterine contractions (UC) objectified during the consultation (questioning, clinical examination, external tocography),

And/or clinical or ultrasound changes of the uterine cervix;

Disqualifiers

Age < 18 years;

Premature rupture of membranes

Patient in labor with imminent delivery.

Total absence of social care

Trial design

Treatments tested in this trial

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

Treatment groups

No treatment groups listed

Sponsors and collaborators

Assistance Publique - Hôpitaux de Paris

Lead sponsor

URC-CIC Paris Descartes Necker Cochin

Collaborator