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Maternal Plasmatic Regulatory T Cells and Th17 as Possible Diagnosis Markers of Acute Chorioamnionitis

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01610258
Acronym
ICAR
Enrollment
95
Registered
2012-06-01
Start date
2013-03-26
Completion date
2016-12-08
Last updated
2024-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pathology of Pregnancy

Keywords

pregnancy, chorioamnionitis, PPROM, Treg

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.

Interventions

OTHERBlood and placenta samples

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.

Sponsors

Centre Hospitalier Universitaire Dijon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Evaluate the percentage of Treg in maternal blood at the time of admissionthe day of delivery or 7 days after the admission if no delivery

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026