Development and Clinical Evaluation of an Innovative Medical Device to Predict Preterm Birth (PrediMAP)
Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Oct 17, 2022
Trial Information
Current as of July 25, 2025
Recruiting
Keywords
ClinConnect Summary
The PrediMAP clinical trial is studying a new medical device designed to help predict whether a pregnant woman might give birth within the next week, specifically focusing on those who are experiencing signs of preterm labor. The goal is to see how well this device can accurately identify women who are at risk for delivering early, which could help doctors provide better care and make more informed decisions.
To be eligible for this study, participants need to be pregnant and experiencing certain symptoms that suggest they may be in preterm labor, such as contractions or changes in the cervix. Women aged 18 and older who visit the emergency room between 22 and 34 weeks of pregnancy for these concerns may qualify. If you decide to participate, you will undergo tests with this new device, and your experience will help researchers understand its effectiveness. It's important to know that some individuals, such as those who are in active labor or have certain medical conditions, may not be eligible for this trial.
Gender
FEMALE
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 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
About Assistance Publique Hôpitaux De Paris
Assistance Publique - Hôpitaux de Paris (AP-HP) is a leading public hospital system in France, renowned for its commitment to healthcare excellence and innovative medical research. As a prominent clinical trial sponsor, AP-HP plays a pivotal role in advancing medical knowledge and improving patient care through rigorous scientific investigations across a wide range of therapeutic areas. With a focus on collaboration and interdisciplinary approaches, AP-HP leverages its extensive network of hospitals and expert clinicians to facilitate high-quality clinical trials that adhere to the highest ethical and regulatory standards, ultimately aiming to translate research findings into tangible health benefits for diverse patient populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Colombes, , France
Patients applied
Trial Officials
Jeanne SIBIUDE, MD, PhD
Principal Investigator
APHP
François GOFFINET, Pr
Study Chair
APHP
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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