Predicting preterm birth using an innovative medical device

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to clinically validate the PrediMAP device, which predicts delivery within 7 days for women experiencing preterm labor symptoms. The device utilizes biomarkers identified through over a decade of research to enhance the management of pregnancies at risk of preterm birth. By collecting vaginal secretions and analyzing clinical data, the study seeks to improve the accuracy of preterm birth predictions, potentially reducing unnecessary hospitalizations and improving outcomes for mothers and infants.

Why it matters

Who can join: the full rules

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

Where it's running

• Louis Mourier Hospital
  Colombes, France Recruiting

Study contacts

• Principal investigator: Jeanne SIBIUDE, MD, PhD — Aphp
• Study coordinator: Jeanne SIBIUDE, MD, PhD
• Email: jeanne.sibiude@aphp.fr
• Phone: +33 1 47 60 66 11

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.