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

Pathology of Pregnancy Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01610258
• Other study ID #: BARDOU-PHRC-2011
• Status: Completed
• Phase: N/A
• Start date: March 26, 2013
• Est. completion date: December 8, 2016

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: December 8, 2016
• Est. primary completion date: December 8, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chorioamnionitis
• Pathology of Pregnancy

Intervention

Other:
• Blood 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.

Locations

Country	Name	City	State
France	Maternité du CHU de Dijon	Dijon	Bourgogne
France	Hôpital Hautepierre	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the percentage of Treg in maternal blood at the time of admission		the day of delivery or 7 days after the admission if no delivery