Actively Recruiting
Development and Clinical Evaluation of an Innovative Medical Device to Predict Preterm Birth (PrediMAP)
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-11-20
3600
Participants Needed
1
Research Sites
233 weeks
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
U
URC-CIC Paris Descartes Necker Cochin
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Development and Clinical Evaluation of an Innovative Medical Device to Predict Preterm Birth (PrediMAP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant with live fetus(es)
- Emergency room visit between 22 and 34 weeks + 6 days of pregnancy
- Suspected preterm labor defined by uterine contractions during consultation and/or clinical or ultrasound changes of the cervix
- Or visiting for another reason with clinical or ultrasound changes of the cervix
- Have social security coverage or AME
- Signed informed consent form
You will not qualify if you...
- Younger than 18 years
- Premature rupture of membranes
- In labor with imminent delivery
- No social care coverage
- Minor or legally protected adult (guardianship or curatorship)
- Do not speak French and not accompanied by a French-speaking person
- Multiple pregnancy with three or more fetuses
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Louis Mourier Hospital
Colombes, France, 92700
Actively Recruiting
Research Team
J
Jeanne SIBIUDE, MD, PhD
CONTACT
K
Karima MESBAHI IHADJADENE, Project Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
0
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