Predicting preterm birth using an innovative medical device
Development and Clinical Evaluation of an Innovative Medical Device to Predict Preterm Birth: From Basic Research to Obstetric Emergencies
NA · Assistance Publique - Hôpitaux de Paris · NCT05586334
This study is testing a new device that helps predict if pregnant women showing signs of preterm labor will give birth within a week, to improve care for both mothers and babies.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 3600 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Locations | 1 site (Colombes) |
| Trial ID | NCT05586334 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are pregnant women between 22 and 34 weeks of gestation who present with symptoms of preterm labor.
Not a fit: Patients who are under 18 years old, in imminent labor, or have multiple pregnancies of three or more will not benefit from this study.
Why it matters
Potential benefit: If successful, this device could significantly improve the prediction of preterm births, leading to better management and outcomes for at-risk pregnancies.
How similar studies have performed: While there have been various approaches to predicting preterm birth, the specific use of the PrediMAP device represents a novel application of biomarkers in this context.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Colombes
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Preterm Labor, obstetrics, medical device, preterm labor, preterm birth, prediction