Study of the Role of Tissular Maternofetal Alloimmunization in Placentation Pathologies - Full Text View

Sponsored by:	University Hospital, Limoges
Information provided by:	University Hospital, Limoges
ClinicalTrials.gov Identifier:	NCT00456118

Purpose

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
Recurrent Pregnancy Losses Preeclampsia Intervillositis

Study Type:	Observational
Study Design:	Screening, Longitudinal, Defined Population, Retrospective/Prospective Study
Official Title:	Study of the Role of Tissular Maternofetal Alloimmunization in Placentation Pathologies

Further study details as provided by University Hospital, Limoges:

Estimated Enrollment:	150
Study Start Date:	September 2006

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00456118

Contacts

Contact: Vincent GUIGONIS, MD

05 55 05 68 67

vincent.guigonis@chu-limoges.fr

Locations

France
LIMOGES University Hospital	Recruiting
LIMOGES, France, 87042
Contact: Vincent GUIGONIS, MD 05 55 05 68 67 vicent.guigonis@chu-limoges.fr
Principal Investigator: AUBARD Yves, MD
Principal Investigator: Jean Lu EYRAUD, MD
Principal Investigator: Pascal PIVER, MD
Principal Investigator: Jérôme GANA, MD
Principal Investigator: Emmanuel DECROISETTE, MD
Principal Investigator: Sophie GHECQ, MD
Toulouse University Hospital	Recruiting
TOULOUSE, France, 31059
Sub-Investigator: Olivier PARANT, MD
Sub-Investigator: Laure CONNAN, MD
Sub-Investigator: Sylvie KESSLER, MD
Sub-Investigator: Yann TANGUY LE GAC, MD
Bordeaux University Hospital	Recruiting
BORDEAUX, France, 33076
Sub-Investigator: Jacques HOROVITZ, MD
Sub-Investigator: Frédéric GUYON, MD
South Reunion Hospital	Recruiting
SAINT PIERRE, France, 97448
Sub-Investigator: Georges BARAU, MD
Sub-Investigator: Michel HEISERT, MD
Sub-Investigator: Hanitra RANDRIANAIVO, MD
Sub-Investigator: Pierre Yves ROBILLARD, MD
Saint Antoine Hospital	Recruiting
PARIS, France, 75012
Sub-Investigator: Bruno CARBONNE, MD
Trousseau Hospital	Recruiting
PARIS, France, 75571
Sub-Investigator: Marie GONZALES, MD
Tenon Hospital	Recruiting
PARIS, France, 75020
Sub-Investigator: Nadia BERKANE, MD

Sponsors and Collaborators

University Hospital, Limoges

Investigators

Principal Investigator:

Vincent GUIGONIS, MD

University Hospital, Limoges

More Information

No publications provided

Study ID Numbers:	I06014
Study First Received:	April 3, 2007
Last Updated:	April 3, 2007
ClinicalTrials.gov Identifier:	NCT00456118 History of Changes
Health Authority:	France: Direction Générale de la Santé

Keywords provided by University Hospital, Limoges:

recurrent pregnancy losses
preeclampsia
intervillositis
maternofetal alloimmunization

Study placed in the following topic categories:

Hypertension, Pregnancy-Induced
Pregnancy Complications
Eclampsia
Pre-Eclampsia

Preeclampsia
Recurrence
Hypertension

Additional relevant MeSH terms:

Hypertension, Pregnancy-Induced
Pregnancy Complications
Pre-Eclampsia

ClinicalTrials.gov processed this record on July 02, 2009