Study of the Role of Tissular Maternofetal Alloimmunization in Placentation Pathologies

Completed

• Conditions: Intervillositis; Recurrent Pregnancy Losses; Preeclampsia

• Registration Number: NCT00456118
• Lead Sponsor: University Hospital, Limoges

Brief Summary

Justification:

We have recently demonstrated that maternofetal alloimmunization was not limited to blood cells: maternal alloimmunization against a glomerular podocyte antigen expressed by the placenta can induce neonatal membranous glomerulonephritis.

Early recurrent pregnancy losses, preeclampsia and intervillositis are obstetrical pathologies which share an anomaly of placentation. Pathophysiology of these diseases is not yet fully understood; nevertheless the hypothesis of an incompatibility between mother and child is often mentioned. The aim of this project is to detect and study the cases of recurrent pregnancy losses, preeclamspia and intervillositis which could be induced by tissular maternofetal alloimmunization.

Materials and methods:

Patients suffering from recurrent pregnancy losses of unknown origin, preeclamspia or intervillositis will be included in this project. Mothers' sera will be studied by indirect immunofluorescence and Western Blot on placental biopsies from different origins and gestational ages. This stage will enable us to detect possible maternal allo-antibodies. After detecting and revealing antibodies, nature of the target antigen will be identified by immunoprecipitation of placental extracts, using the positive sera. Immunoprecipitation will be followed by a mass spectrometry analysis of detected proteins.

Expected results:

This study will enable us:

* to detect new cases of tissular maternofetal alloimmunization

* to improve our knowledge of mechanisms leading to anomalies of placentation

* to carry out a specific, preventive therapeutic approach for cases induced by tissular alloimmunization.

Key words:

Recurrent pregnancy losses, Preeclampsia, Intervillositis, maternofetal alloimmunization.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2007-04-03
• Study First Submitted QC: 2007-04-03
• Study First Posted: 2007-04-04
• Status Verified: 2009-05
• Primary Completion: 2009-07
• Study Completion: 2009-12
• Last Update Submitted: 2018-08-10
• Last Update Posted: 2018-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 83

Inclusion Criteria

• Recurrent pregnancy losses : patient having or having suffered from at least 3 consecutive, unexplained recurrent pregnancy losses, during the first 3 months of pregnancy, with the same paerson/man.
• Preeclampsia : blood pressure > 140/90 mm Hg ; proteinuria > 0,3 g/ 24 h
• Intervillositis : patient suffering or having suffered from intervillositis

Exclusion Criteria

• Recurrent pregnancy losses : uterine pathology, endocrine pathology, autoimmune pathology, coagulation and hemostasis pathology, karyotype anomaly.
• Preeclampsia : pre-existing high blood pressure, pre-existing diabetes, pre-existing renal disease, antiphospholipid antibodies syndrome
• Intervillositis : intervillositis with villositis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (7)

Bordeaux University Hospital; 🇫🇷 Bordeaux, France

LIMOGES University Hospital; 🇫🇷 Limoges, France

Tenon Hospital; 🇫🇷 Paris, France

Saint Antoine Hospital; 🇫🇷 Paris, France

South Reunion Hospital; 🇫🇷 Saint Pierre, France

Trousseau Hospital; 🇫🇷 Paris, France

Toulouse University Hospital; 🇫🇷 Toulouse, France