Clinical trial NCT05586334: Development and Clinical Evaluation of an Innovative Medical Device to Predict Preterm Birth (PrediMAP)
Official title: Development and Clinical Evaluation of an Innovative Medical Device to Predict Preterm Birth: from Basic Research to Obstetric Emergencies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Preterm Labor
Keywords: obstetrics
medical device
preterm labor
preterm birth
prediction
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-10-19
Enrollment: 3600
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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

Eligibility 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

Primary outcomes:
measure: 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).
Secondary outcomes:
measure: delivery occurrence 14 days after consultation
timeFrame: assessed after end of follow-up (5.5 months)
measure: delivery <32 weeks of gestation, <34 weeks and <37 weeks
timeFrame: assessed after end of follow-up (5.5 months)
measure: neonatal mortality;
timeFrame: assessed after end of follow-up (5.5 months)
measure: severe neonatal morbidity
timeFrame: assessed after end of follow-up (5.5 months)
measure: EPDS score at inclusion and after delivery
timeFrame: assessed after end of follow-up (5.5 months)
Other outcomes:
Locations:
city: Colombes
country: France
facility: Louis Mourier Hospital
Study officials:
affiliation: APHP
name: Jeanne SIBIUDE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: APHP
name: François GOFFINET, Pr
role: STUDY_CHAIR
References: