Study of the Role of Tissular Maternofetal Alloimmunization in Placentation Pathologies

NCT00456118 | Completed

• 1 other identifier: I06014
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 7

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.

Conditions

Recurrent Pregnancy Losses; Preeclampsia; Intervillositis

Keywords

recurrent pregnancy losses; preeclampsia; intervillositis; maternofetal alloimmunization

Study Arms (3)

repeated miscarriages

60 womens for repeated miscarriages will be included

Preeclampsia

70 women for pre-eclampsia will be included

intervillites

20 women for intervillites will be included

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Neonatal pathologies can be caused by an alloimmunisation maternal fetal tissue, it's conceivable that certain pathologies. Obstetrics may be part of the same mechanism. Among these pathologies placentaires, for whom a "maternal-fetal incompatibility" is often mentioned, could be secondary to tissue alloimmunization against antigens independent of the immune system

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (7)

Bordeaux University Hospital

Bordeaux, 33076, France

Location

LIMOGES University Hospital

Limoges, 87042, France

Location

Saint Antoine Hospital

Paris, 75012, France

Location

Tenon Hospital

Paris, 75020, France

Location

Trousseau Hospital

Paris, 75571, France

Location

South Reunion Hospital

Saint-Pierre, 97448, France

Location

Toulouse University Hospital

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Vincent GUIGONIS, MD

  University Hospital, Limoges

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2007
• First Posted: April 4, 2007
• Study Start: September 1, 2006
• Primary Completion: July 1, 2009
• Study Completion: December 1, 2009
• Last Updated: August 13, 2018

Record last verified: 2009-05

Locations

FR (7)