Study of the Role of Tissular Maternofetal Alloimmunization in Placentation Pathologies

Sponsor

University Hospital, Limoges (Other)

Overall Status

Completed

CT.gov ID

NCT00456118

Collaborator

(none)

Enrollment

Locations

Duration (Months)

11.9

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Recurrent Pregnancy Losses Preeclampsia Intervillositis

Study Design

Study Type:

Observational

Actual Enrollment :

83 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Study of the Role of Tissular Maternofetal Alloimmunization in Placentation Pathologies

Study Start Date :

Sep 1, 2006

Actual Primary Completion Date :

Jul 1, 2009

Actual Study Completion Date :

Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Bordeaux University Hospital	Bordeaux	France	33076
2	LIMOGES University Hospital	Limoges	France	87042
3	Saint Antoine Hospital	Paris	France	75012
4	Tenon Hospital	Paris	France	75020
5	Trousseau Hospital	Paris	France	75571
6	South Reunion Hospital	Saint Pierre	France	97448
7	Toulouse University Hospital	Toulouse	France	31059