Maternal Plasmatic Regulatory T Cells and Th17 as Possible Diagnosis Markers of Acute Chorioamnionitis (ICAR)
Primary Purpose
Pathology of Pregnancy
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood and placenta samples
Sponsored by
About this trial
This is an interventional diagnostic trial for Pathology of Pregnancy focused on measuring pregnancy, chorioamnionitis, PPROM, Treg
Eligibility Criteria
Inclusion Criteria:
- Informed consent signed
- Patient affiliated with a social security scheme
- term pregnancy betwwen 24 and 34 weeks
- PPROM diagnosis
- singleton pregnancy
Exclusion Criteria:
- delivery occured in 1 hour after admission
- hemorragic praevia placenta or retro-placental hematoma
- confirmed autoimmune or inflammatory disease
- confirmed infectious disease by VIH, VHC, and VHB
Sites / Locations
- Maternité du CHU de DijonRecruiting
- Hôpital HautepierreRecruiting
Outcomes
Primary Outcome Measures
Evaluate the percentage of Treg in maternal blood at the time of admission
Secondary Outcome Measures
Full Information
NCT ID
NCT01610258
First Posted
May 31, 2012
Last Updated
December 3, 2014
Sponsor
Centre Hospitalier Universitaire Dijon
1. Study Identification
Unique Protocol Identification Number
NCT01610258
Brief Title
Maternal Plasmatic Regulatory T Cells and Th17 as Possible Diagnosis Markers of Acute Chorioamnionitis
Acronym
ICAR
Official Title
Contribution of the Study of Maternal Plasmatic Regulator T Cells and Th17 for the Diagnosis of Acute Chorioanmionitis Among Women Hospitalized for Premature Rupture of Fetal Membranes (PPROM) Between 24 and 34 Gestation Weeks
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
September 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate if regulator T cells (Treg) and Th17 level modifications in maternal blood and placenta could be correlated to a chorioamnionitis, in women hospitalized for PPROM.
Detailed Description
Acute chorioamnionitis is the principal antecedent of premature birth and an important contributor to specific neonatal and other complications that may extend throughout subsequent life. The PPROM is a high risk condition for developing chorioamnionitis. Available biological markers have a low prognostic value. Indeed, currently the diagnosis of intra-uterine infection relies only on placental cultures and anatomo-pathological exam after the delivery.
Moreover, pregnancy is an immunologic particular condition. Indeed an immune tolerance is required with respect to the fetus and is mediated by Treg lymphocytes, which suppressed Th17 activity.
Recent studies have shown among women with frequent miscarriages, a balance between Treg and Th17, with a decrease in Treg number and an increase in Th17 number in decidua and blood.
In case of infection, the immune pro-inflammatory response (Th17) is restored in peripheric tissues and in blood in order to limit the extention of intra-uterine infection. This restoration of this pro-inflammatory response could be due to a modification of Treg number ou tolerogenic activity.
In this context, our hypothesis is that chorioamnionitis will lead to a decrease of treg proportion and an increase of Th17 proportion in lymphocyte populations of maternal blood and placenta, with a back to values near than which is observed in beginning of pregnancy or in no pregnant women.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pathology of Pregnancy
Keywords
pregnancy, chorioamnionitis, PPROM, Treg
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Blood and placenta samples
Intervention Description
The placenta sample is realised, specially for the study, in surgical unit after the delivery.
The blood samples are taken, specially for the study, the day of admission and at time of delivery or seven days after the admission.
Primary Outcome Measure Information:
Title
Evaluate the percentage of Treg in maternal blood at the time of admission
Time Frame
the day of delivery or 7 days after the admission if no delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Informed consent signed
Patient affiliated with a social security scheme
term pregnancy betwwen 24 and 34 weeks
PPROM diagnosis
singleton pregnancy
Exclusion Criteria:
delivery occured in 1 hour after admission
hemorragic praevia placenta or retro-placental hematoma
confirmed autoimmune or inflammatory disease
confirmed infectious disease by VIH, VHC, and VHB
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marc BARDOU, Pr
Phone
380-393-433
Ext
+33
Email
Marc.Bardou@u-bourgogne.fr
Facility Information:
Facility Name
Maternité du CHU de Dijon
City
Dijon
State/Province
Bourgogne
ZIP/Postal Code
21000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc BARDOU, Pr
Phone
380-393-433
Ext
+33
Email
Marc.Bardou@u-bourgogne.fr
First Name & Middle Initial & Last Name & Degree
Isabelle LE RAY, Md
Phone
380-393-223
Ext
+33
Email
Isabelle.Le-Ray-Ferrieres@u-bourgogne.fr
First Name & Middle Initial & Last Name & Degree
Paul SAGOT, Pr
Facility Name
Hôpital Hautepierre
City
Strasbourg
ZIP/Postal Code
67200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Israël NISAND
12. IPD Sharing Statement
Learn more about this trial
Maternal Plasmatic Regulatory T Cells and Th17 as Possible Diagnosis Markers of Acute Chorioamnionitis
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