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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Preterm Labor
• Intervention / Treatment: Biological: Collection of vaginal secretions; Biological: Collection of the placenta and the membranes; Other: Administration of EPDS questionnaire

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

• Study Type: Interventional
• Enrollment (Estimated): 3600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeanne SIBIUDE, MD, PhD; Phone Number: +33 1 47 60 66 11; Email: jeanne.sibiude@aphp.fr
• Study Contact Backup: Name: Karima MESBAHI IHADJADENE, Project Manager; Phone Number: 33 1 58 41 12 11; Email: karima.mesbahi@aphp.fr

Study Locations

• France
  • Colombes, France, 92700
    • Recruiting
    • Louis Mourier Hospital
    • Contact: Jeanne SIBIUDE, MD, PhD; Phone Number: +33 1 47 60 66 11; Email: jeanne.sibiude@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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	Gestational age at delivery, in 4 categories.	assessed after end of follow-up (5.5 months)
neonatal mortality;		assessed after end of follow-up (5.5 months)
severe neonatal morbidity	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	assessed after end of follow-up (5.5 months)
EPDS score at inclusion and after delivery		assessed after end of follow-up (5.5 months)

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Jeanne SIBIUDE, MD, PhD, APHP; Study Chair: François GOFFINET, Pr, APHP

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: July 28, 2022
• First Submitted That Met QC Criteria: October 17, 2022
• First Posted (Actual): October 19, 2022

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: preterm birth; medical device; preterm labor; prediction; obstetrics
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth; Obstetric Labor, Premature
• Other Study ID Numbers: APHP220187; 2022-A00588-35 (Other Identifier: ID-RCB Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No