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Identification of Spontaneous Delivery Markers

NCT02225717 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 238

Last updated 2025-12-11

No results posted yet for this study

Summary

The investigators project aims to identify, in pregnant women, discriminating molecules to allow an early detection of women who will spontaneously deliver prematurely, suitable in routine clinical practice.

Human parturition is tightly correlated with hormonal changes at the maternal-fetal interface during pregnancy, that may control cell interactions and fetal membranes (the water bag) remodelling. Precocious remodelling may lead to a premature onset of labor, associated or not with premature rupture of membrane whether the cause is infectious or not.

In this regard, remodelled fetal membranes overlying the cervix may discharge signals that could be detectable in cervico-vaginal fluids and serve as biomarkers of the imminence of delivery. Such information on delivery timing may be of great importance for an adequate prediction that would change drastically the management of threatening preterm delivery.

Conditions

  • Preterm Labor (24 GA - 32 GA)

Interventions

PROCEDURE

Cervicovaginal swab

Sample of cervicovaginal secretions made by the surgical team using a sterile swab introduced directly into the posterior fornix of vagina for one minute during the insertion of the urinary catheter

Sponsors & Collaborators

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Celine MEHATS, PhD · INSERM U1016 - Cochin Hospital Public Hospitals of Paris

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-12-14
Primary Completion
2017-11-14
Completion
2018-04-16

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02225717 on ClinicalTrials.gov