Development and Clinical Evaluation of an Innovative Medical Device to Predict Preterm Birth (PrediMAP) (PrediMAP)
Primary Purpose
Preterm Labor
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Collection of vaginal secretions
Collection of the placenta and the membranes
Administration of EPDS questionnaire
Sponsored by
About this trial
This is an interventional prevention trial for Preterm Labor focused on measuring obstetrics, medical device, preterm labor, preterm birth, prediction
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
Sites / Locations
- Louis Mourier Hospital
Outcomes
Primary Outcome Measures
Delivery occurence 7 days after inclusion
Secondary Outcome Measures
delivery occurrence 14 days after consultation
delivery <32 weeks of gestation, <34 weeks and <37 weeks
Gestational age at delivery, in 4 categories.
neonatal mortality;
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
EPDS score at inclusion and after delivery
Full Information
NCT ID
NCT05586334
First Posted
July 28, 2022
Last Updated
October 17, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT05586334
Brief Title
Development and Clinical Evaluation of an Innovative Medical Device to Predict Preterm Birth (PrediMAP)
Acronym
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
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2022 (Anticipated)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
June 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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).
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Labor
Keywords
obstetrics, medical device, preterm labor, preterm birth, prediction
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Masking Description
lack of result reporting
Allocation
N/A
Enrollment
3600 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Collection of vaginal secretions
Intervention Description
In all women included: Vaginal secretion sampling at the time of the obstetrical emergency consultation.
Intervention Type
Biological
Intervention Name(s)
Collection of the placenta and the membranes
Intervention Description
In cohort 1, for 30 patients at the Port Royal Maternity Hospital, the placenta and membranes will be collected after delivery
Intervention Type
Other
Intervention Name(s)
Administration of EPDS questionnaire
Intervention Description
In cohort 3, the EPDS questionnaire will be administered to all participants after the consultation in the emergency department.
Primary Outcome Measure Information:
Title
Delivery occurence 7 days after inclusion
Time Frame
Cohort 1 : assessed 15-21 days after inclusion of each patient. Cohort 3: assessed after end of follow-up (5.5 months).
Secondary Outcome Measure Information:
Title
delivery occurrence 14 days after consultation
Time Frame
assessed after end of follow-up (5.5 months)
Title
delivery <32 weeks of gestation, <34 weeks and <37 weeks
Description
Gestational age at delivery, in 4 categories.
Time Frame
assessed after end of follow-up (5.5 months)
Title
neonatal mortality;
Time Frame
assessed after end of follow-up (5.5 months)
Title
severe neonatal morbidity
Description
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
Time Frame
assessed after end of follow-up (5.5 months)
Title
EPDS score at inclusion and after delivery
Time Frame
assessed after end of follow-up (5.5 months)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeanne SIBIUDE, MD, PhD
Phone
+33 1 47 60 66 11
Email
jeanne.sibiude@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Karima MESBAHI IHADJADENE, Project Manager
Phone
33 1 58 41 12 11
Email
karima.mesbahi@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeanne SIBIUDE, MD, PhD
Organizational Affiliation
APHP
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
François GOFFINET, Pr
Organizational Affiliation
APHP
Official's Role
Study Chair
Facility Information:
Facility Name
Louis Mourier Hospital
City
Colombes
ZIP/Postal Code
92700
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeanne SIBIUDE, MD, PhD
Phone
+33 1 47 60 66 11
Email
jeanne.sibiude@aphp.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Development and Clinical Evaluation of an Innovative Medical Device to Predict Preterm Birth (PrediMAP)
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