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

January 11, 2013
April 11, 2014
November 2010
May 2014   (final data collection date for primary outcome measure)
Protein overexpression [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Setting of measurements of proteins in the supernatant of chorionic cells
Same as current
Complete list of historical versions of study NCT01767649 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Inflammatory Signature of Human Chorionic Cells
Inflammatory Signature of Chorionic Cells as Markers of Premature Labor

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.

· 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).

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Cord blood, placenta and maternal blood

Non-Probability Sample

Normal pregnant women followed for their pregnancy in the maternity

Pregnancy
  • Other: Caesarean
    Collection of tissues and blood
  • Other: Vaginal delivery
    Collection of tissues and blood
  • Caesarean
    Normal pregnant women at term without complication during pregnancy and without inflammatory disorders
    Intervention: Other: Caesarean
  • Vaginal Delivery
    Normal pregnant women at term without complication during pregnancy and without inflammatory disorders
    Intervention: Other: Vaginal delivery

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
68
December 2014
May 2014   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01767649
NI10056
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Céline Méhats, PhD Institut National de la Santé Et de la Recherche Médicale, France
Assistance Publique - Hôpitaux de Paris
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP