Inflammatory Signature of Human Chorionic Cells (TROPHY)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01767649
First received: January 11, 2013
Last updated: April 11, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Pregnancy
Other: Caesarean
Other: Vaginal delivery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Inflammatory Signature of Chorionic Cells as Markers of Premature Labor

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Protein overexpression [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Setting of measurements of proteins in the supernatant of chorionic cells


Biospecimen Retention:   Samples With DNA

Cord blood, placenta and maternal blood


Estimated Enrollment: 68
Study Start Date: November 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Caesarean
Normal pregnant women at term without complication during pregnancy and without inflammatory disorders
Other: Caesarean
Collection of tissues and blood
Vaginal Delivery
Normal pregnant women at term without complication during pregnancy and without inflammatory disorders
Other: Vaginal delivery
Collection of tissues and blood

Detailed Description:

· Background

During human gestation, fetal membranes (the "water bag") encompass the amnion, facing the amniotic cavity, and the chorion, lining the maternal decidua and comprising trophoblast cells. Membranes usually remain intact until their spontaneous rupture, close to the first stage of labor at term. Often seen as a simple inert shell, with a role of "airbag" for the developing fetus, the membranes provide yet a large surface of interaction between maternal and fetal tissues and function as a transient endocrine organ with immune properties. Indeed human parturition is tightly correlated with hormonal changes at the maternal-fetal interface during pregnancy, that may control cell interactions and chorio-decidua remodeling, the amnion remaining usually intact until the final break. Precocious remodeling may lead to a premature onset of labor, associated or not with premature rupture of membrane whether the cause is infectious or not. A better understanding of this membrane remodeling may thus offer new avenues to define biomarkers of preterm labor.

Hereof, the fact that the mother-to-be accepts and keeps the fetus for months within her womb has long being seen as an enigma, since the fetus is a semi-allograft, half of his genome being of paternal, thus of foreign, origin. This apparent paradox was deciphered by the demonstration of the set-up of an immunotolerance at the site of implantation through the education of maternal immune cells (Natural Killer and T cells) by the fetal trophoblast. This immunotolerance is normally maintained throughout pregnancy, and some recurrent spontaneous miscarriages have been shown to be due to the loss of this immunotolerance, which activates the rejection of the semi-allograft.

In this regard, remodeled fetal membranes overlying the cervix may discharge signals that could be detectable in cervicovaginal 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.

· Current proposal The objective of this study is to characterize the fetal and maternal cells in the chorio-decidua during the remodeling of the membranes using our well-established cell model (Hervé et al. 2008, J Immunol).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Normal pregnant women followed for their pregnancy in the maternity

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Minor
  • Without Health Insurance
  • Inflammatory Disorders (diabetes, twin, autoimmune disesses, etc)
  • Infection HIV, hepatitis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01767649

Locations
France
INSERM
Paris, France, 75014
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Céline Méhats, PhD Institut National de la Santé Et de la Recherche Médicale, France
  More Information

Publications:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01767649     History of Changes
Other Study ID Numbers: NI10056
Study First Received: January 11, 2013
Last Updated: April 11, 2014
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Pregnancy
Remodelling
Extracellular matrix
Biomarkers

ClinicalTrials.gov processed this record on September 22, 2014