NCT01767649

Brief Summary

The purpose of this study is to identify molecules produced specifically by the cells from the chorionic membranes of the materno-fetal interface ("the water bag") sign for the activation of preterm labor.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 14, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

3.5 years

First QC Date

January 11, 2013

Last Update Submit

February 11, 2026

Conditions

Pregnancy

Keywords

PregnancyRemodellingExtracellular matrixBiomarkers

Outcome Measures

Primary Outcomes (1)

  • Protein overexpression

    Setting of measurements of proteins in the supernatant of chorionic cells

    1 year

Study Arms (2)

Caesarean

Normal pregnant women at term without complication during pregnancy and without inflammatory disorders

Other: Caesarean

Vaginal Delivery

Normal pregnant women at term without complication during pregnancy and without inflammatory disorders

Other: Vaginal delivery

Interventions

CaesareanOTHER

Collection of tissues and blood

Caesarean
Vaginal deliveryOTHER

Collection of tissues and blood

Vaginal Delivery

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Normal pregnant women followed for their pregnancy in the maternity

You may qualify if:

  • \>18y old
  • Singleton
  • Normal pregnancy without complication
  • \>37 weeks of gestation

You may not qualify if:

  • Minor
  • Without Health Insurance
  • Inflammatory Disorders (diabetes, twin, autoimmune disesses, etc)
  • Infection HIV, hepatitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

INSERM

Paris, 75014, France

Location

Related Publications (3)

  • Herve R, Schmitz T, Evain-Brion D, Cabrol D, Leroy MJ, Mehats C. The PDE4 inhibitor rolipram prevents NF-kappaB binding activity and proinflammatory cytokine release in human chorionic cells. J Immunol. 2008 Aug 1;181(3):2196-202. doi: 10.4049/jimmunol.181.3.2196.

    PMID: 18641359BACKGROUND

  • Mehats C, Schmitz T, Marcellin L, Breuiller-Fouche M. [Biochemistry of fetal membranes rupture]. Gynecol Obstet Fertil. 2011 Jun;39(6):365-9. doi: 10.1016/j.gyobfe.2011.04.006. Epub 2011 May 24. French.

    PMID: 21602079BACKGROUND

  • Marcellin L, Schmitz T, Messaoudene M, Chader D, Parizot C, Jacques S, Delaire J, Gogusev J, Schmitt A, Lesaffre C, Breuiller-Fouche M, Caignard A, Vaiman D, Goffinet F, Cabrol D, Gorochov G, Mehats C. Immune Modifications in Fetal Membranes Overlying the Cervix Precede Parturition in Humans. J Immunol. 2017 Feb 1;198(3):1345-1356. doi: 10.4049/jimmunol.1601482. Epub 2016 Dec 28.

    PMID: 28031337RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Cord blood, placenta and maternal blood

MeSH Terms

Interventions

Cesarean Section

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Céline Méhats, PhD

    Institut National de la Santé Et de la Recherche Médicale, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2013

First Posted

January 14, 2013

Study Start

November 1, 2010

Primary Completion

May 1, 2014

Study Completion

November 1, 2014

Last Updated

February 13, 2026

Record last verified: 2026-02

Locations

FR(1)