Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-30 @ 7:26 AM
Study NCT ID:
NCT05586334
Status:
RECRUITING
Last Update Posted:
2025-11-20
First Post:
2022-07-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development and Clinical Evaluation of an Innovative Medical Device to Predict Preterm Birth (PrediMAP)
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Development and Clinical Evaluation of an Innovative Medical Device to Predict Preterm Birth: From Basic Research to Obstetric Emergencies
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PrediMAP
Brief 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).
Detailed Description:
Preterm delivery (birth before 37 weeks of gestation) accounts for 12% of worldwide births each year: 15 million children. It is the leading cause of infant mortality. In France, it accounts for 60,000 births per year, 10,000 of them very preterm (before 32 weeks) and at very high risk of neonatal complications and childhood sequelae Given the high risks of death and of neurodevelopmental disabilities and learning disorders among survivors, preterm birth (PTB) is a major public health problem .
Over the past 30 years, measures to prevent preterm deliveries have not proved effective, and the incidence of PTB is rising or at best stable in most developed countries, including France. Important advances have nonetheless improved the management of pregnancies at risk of PTB and of preterm children.
From 100,000 to 150,000 women a year come to maternity unit EDs for symptoms suggesting PTL. Although fewer than half will be admitted to the hospital, our team has shown that PTL is the leading reason for hospitalization among pregnant women (45,000 admissions/year) in France \[4\]. In the USA, PTL is also the main cause of hospitalization during pregnancy, with costs estimated at $820 million annually . This hospitalization benefits only those women who finally do give birth preterm.
The PrediMAP project's ambition is to use new markers involved in the mechanism of PTL in clinical practice - biomarkers that are the fruit of more than 10 years of basic research at the Institut Cochin. The objective is to combine their measurement with clinical and ultrasound data to construct an algorithm to predict PTB within 7 days after the test, one that medical teams can use in obstetric EDs.
The final objective is to obtain a personalized prediction of delivery within 7 days via an algorithm integrated in the IVD-MD that includes clinical and ultrasound data with these biomarker measurements.
This study is conducted in 3 phases (3 cohorts).
* Objectives of Cohort 1 (Development) :
1. Collect vaginal samples for development of the device
2. Collect clinical and ultrasound data for the predictive algorithm
3. Collect placenta and membrane samples to identify additional biomarkers
* Objective of Cohort 2 (Technical validation ): Validate technically the ergonomics and reliability of the bedside device
* Objective of Cohort 3 (Clinical performance) : Validate the clinical performance of the PrediMAP solution in the target population
Over the past 30 years, measures to prevent preterm deliveries have not proved effective, and the incidence of PTB is rising or at best stable in most developed countries, including France. Important advances have nonetheless improved the management of pregnancies at risk of PTB and of preterm children.
From 100,000 to 150,000 women a year come to maternity unit EDs for symptoms suggesting PTL. Although fewer than half will be admitted to the hospital, our team has shown that PTL is the leading reason for hospitalization among pregnant women (45,000 admissions/year) in France \[4\]. In the USA, PTL is also the main cause of hospitalization during pregnancy, with costs estimated at $820 million annually . This hospitalization benefits only those women who finally do give birth preterm.
The PrediMAP project's ambition is to use new markers involved in the mechanism of PTL in clinical practice - biomarkers that are the fruit of more than 10 years of basic research at the Institut Cochin. The objective is to combine their measurement with clinical and ultrasound data to construct an algorithm to predict PTB within 7 days after the test, one that medical teams can use in obstetric EDs.
The final objective is to obtain a personalized prediction of delivery within 7 days via an algorithm integrated in the IVD-MD that includes clinical and ultrasound data with these biomarker measurements.
This study is conducted in 3 phases (3 cohorts).
* Objectives of Cohort 1 (Development) :
1. Collect vaginal samples for development of the device
2. Collect clinical and ultrasound data for the predictive algorithm
3. Collect placenta and membrane samples to identify additional biomarkers
* Objective of Cohort 2 (Technical validation ): Validate technically the ergonomics and reliability of the bedside device
* Objective of Cohort 3 (Clinical performance) : Validate the clinical performance of the PrediMAP solution in the target population
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2022-A00588-35 | OTHER | ID-RCB Number | View |