Inflammatory Signature of Human Chorionic Cells (TROPHY)
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ClinicalTrials.gov Identifier: NCT01767649 |
Recruitment Status
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Completed
First Posted
: January 14, 2013
Last Update Posted
: December 23, 2014
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Tracking Information | ||||
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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 |
Protein overexpression [ Time Frame: 1 year ] Setting of measurements of proteins in the supernatant of chorionic cells
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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). |
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Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Retention: Samples With DNA Description: Cord blood, placenta and maternal blood |
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Sampling Method | Non-Probability Sample | |||
Study Population | Normal pregnant women followed for their pregnancy in the maternity | |||
Condition | Pregnancy | |||
Intervention |
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Study Groups/Cohorts |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
24 | |||
Original Estimated Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
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 |
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PRS Account | Assistance Publique - Hôpitaux de Paris | |||
Verification Date | December 2014 |