RecruitingNot Applicable

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

France3,600 participantsStarted 2023-06-08

Plain-language summary

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).

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Delivery occurence 7 days after inclusion

Timeframe: Cohort 1 : assessed 15-21 days after inclusion of each patient. Cohort 3: assessed after end of follow-up (5.5 months).

Trial details

NCT IDNCT05586334

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06

Contact for this trial

Jeanne SIBIUDE, MD, PhD

+33 1 47 60 66 11 jeanne.sibiude@aphp.fr

View on ClinicalTrials.gov More Preterm Labor trials