NCT05586334

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,600

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Jun 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress65%
Jun 2023Dec 2027

First Submitted

Initial submission to the registry

July 28, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 19, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

June 8, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

November 20, 2025

Status Verified

October 1, 2025

Enrollment Period

4 years

First QC Date

July 28, 2022

Last Update Submit

November 17, 2025

Conditions

Preterm Labor

Keywords

obstetricsmedical devicepreterm laborpreterm birthprediction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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)

  • neonatal mortality;

    assessed after end of follow-up (5.5 months)

  • severe neonatal morbidity

    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)

Interventions

Collection of vaginal secretionsBIOLOGICAL

In all women included: Vaginal secretion sampling at the time of the obstetrical emergency consultation.

Collection of the placenta and the membranesBIOLOGICAL

In cohort 1, for 30 patients at the Port Royal Maternity Hospital, the placenta and membranes will be collected after delivery

Administration of EPDS questionnaireOTHER

In cohort 3, the EPDS questionnaire will be administered to all participants after the consultation in the emergency department.

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Louis Mourier Hospital

Colombes, 92700, France

RECRUITING

MeSH Terms

Conditions

Obstetric Labor, PrematurePremature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Jeanne SIBIUDE, MD, PhD

    APHP

    PRINCIPAL INVESTIGATOR

  • François GOFFINET, Pr

    APHP

    STUDY CHAIR

Central Study Contacts

Jeanne SIBIUDE, MD, PhD

CONTACT

+33 1 47 60 66 11jeanne.sibiude@aphp.fr

Karima MESBAHI IHADJADENE, Project Manager

CONTACT

33 1 58 41 12 11karima.mesbahi@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
lack of result reporting
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2022

First Posted

October 19, 2022

Study Start

June 8, 2023

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

November 20, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)