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

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05586334

Collaborator

(none)

3,600

Enrollment

Location

Anticipated Duration (Months)

66.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Preterm Labor	Biological: Collection of vaginal secretions Biological: Collection of the placenta and the membranes Other: Administration of EPDS questionnaire	N/A

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) :

Collect vaginal samples for development of the device
Collect clinical and ultrasound data for the predictive algorithm
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 Design

Study Type:

Interventional

Anticipated Enrollment :

3600 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

Double (Participant, Investigator)

Masking Description:

lack of result reporting

Primary Purpose:

Prevention

Official Title:

Development and Clinical Evaluation of an Innovative Medical Device to Predict Preterm Birth: From Basic Research to Obstetric Emergencies

Anticipated Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2026

Anticipated Study Completion Date :

Jun 1, 2027

Outcome Measures

Primary Outcome Measures

Delivery occurence 7 days after inclusion [Cohort 1 : assessed 15-21 days after inclusion of each patient. Cohort 3: assessed after end of follow-up (5.5 months).]

Secondary Outcome Measures

delivery occurrence 14 days after consultation [assessed after end of follow-up (5.5 months)]
delivery <32 weeks of gestation, <34 weeks and <37 weeks [assessed after end of follow-up (5.5 months)]
Gestational age at delivery, in 4 categories.
neonatal mortality; [assessed after end of follow-up (5.5 months)]
severe neonatal morbidity [assessed after end of follow-up (5.5 months)]
Defined by one or more of the following : Bronchopumonary dyplasia Necrotizing enterocolitis stage 2 or 3 Intraventricular haemorrhage stage 3-4 Periventricular leukomalacia Retinopathy of prematurity stage >3
EPDS score at inclusion and after delivery [assessed after end of follow-up (5.5 months)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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