Inflammatory Signature of Human Chorionic Cells (TROPHY)

Tracking Information
First Submitted Date	January 11, 2013
First Posted Date	January 14, 2013
Last Update Posted Date	December 23, 2014
Study Start Date	November 2010
Actual Primary Completion Date	May 2014 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: January 11, 2013)	Protein overexpression [ Time Frame: 1 year ]; Setting of measurements of proteins in the supernatant of chorionic cells
Original Primary Outcome Measures	Same as current
Change History	Complete list of historical versions of study NCT01767649 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Inflammatory Signature of Human Chorionic Cells
Official Title	Inflammatory Signature of Chorionic Cells as Markers of Premature Labor
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.
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).
Study Type	Observational
Study Design	Observational Model: Cohort; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples With DNA; Description: Cord blood, placenta and maternal blood
Sampling Method	Non-Probability Sample
Study Population	Normal pregnant women followed for their pregnancy in the maternity
Condition	Pregnancy
Intervention	Other: Caesarean Collection of tissues and blood; Other: Vaginal delivery Collection of tissues and blood
Study Groups/Cohorts	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
Publications *	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.; 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: December 19, 2014)	24
Original Estimated Enrollment; (submitted: January 11, 2013)	68
Actual Study Completion Date	November 2014
Actual Primary Completion Date	May 2014 (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender	Sexes Eligible for Study: Female
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	France
Removed Location Countries
Administrative Information
NCT Number	NCT01767649
Other Study ID Numbers	NI10056
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Assistance Publique - Hôpitaux de Paris
Study Sponsor	Assistance Publique - Hôpitaux de Paris
Collaborators	Not Provided
Investigators	Principal Investigator: Céline Méhats, PhD Institut National de la Santé Et de la Recherche Médicale, France
PRS Account	Assistance Publique - Hôpitaux de Paris
Verification Date	December 2014