Inflammatory Signature of Human Chorionic Cells

Pregnancy Clinical Trial

— TROPHY  

Official title:

Inflammatory Signature of Chorionic Cells as Markers of Premature Labor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01767649
• Other study ID #: NI10056
• Status: Completed
• Phase: N/A
• First received: January 11, 2013
• Last updated: December 19, 2014
• Start date: November 2010
• Est. completion date: November 2014

Study information

• Verified date: December 2014
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pregnancy

Intervention

Other:
• Caesarean
Collection of tissues and blood
• Vaginal delivery
Collection of tissues and blood

Locations

Country	Name	City	State
France	INSERM	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (2)

Hervé R, Schmitz T, Evain-Brion D, Cabrol D, Leroy MJ, Méhats 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. — View Citation

Méhats C, Schmitz T, Marcellin L, Breuiller-Fouché 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Protein overexpression	Setting of measurements of proteins in the supernatant of chorionic cells	1 year	No