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Study of the Role of Tissular Maternofetal Alloimmunization in Placentation Pathologies

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ClinicalTrials.gov Identifier: NCT00456118
Recruitment Status : Unknown
Verified April 2007 by University Hospital, Limoges.
Recruitment status was:  Recruiting
First Posted : April 4, 2007
Last Update Posted : April 4, 2007
Sponsor:
Information provided by:
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.


Condition or disease
Recurrent Pregnancy Losses Preeclampsia Intervillositis

Study Type : Observational
Enrollment : 150 participants
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Retrospective/Prospective
Official Title: Study of the Role of Tissular Maternofetal Alloimmunization in Placentation Pathologies
Study Start Date : September 2006

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U.S. FDA Resources





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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00456118


Contacts
Contact: Vincent GUIGONIS, MD 05 55 05 68 67 vincent.guigonis@chu-limoges.fr

Locations
France
Bordeaux University Hospital Recruiting
Bordeaux, France, 33076
Sub-Investigator: Jacques HOROVITZ, MD         
Sub-Investigator: Frédéric GUYON, MD         
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         
Saint Antoine Hospital Recruiting
Paris, France, 75012
Sub-Investigator: Bruno CARBONNE, MD         
Tenon Hospital Recruiting
Paris, France, 75020
Sub-Investigator: Nadia BERKANE, MD         
Trousseau Hospital Recruiting
Paris, France, 75571
Sub-Investigator: Marie GONZALES, 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         
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         
Sponsors and Collaborators
University Hospital, Limoges
Investigators
Principal Investigator: Vincent GUIGONIS, MD University Hospital, Limoges

ClinicalTrials.gov Identifier: NCT00456118     History of Changes
Other Study ID Numbers: I06014
First Posted: April 4, 2007    Key Record Dates
Last Update Posted: April 4, 2007
Last Verified: April 2007

Keywords provided by University Hospital, Limoges:
recurrent pregnancy losses
preeclampsia
intervillositis
maternofetal alloimmunization

Additional relevant MeSH terms:
Pre-Eclampsia
Abortion, Habitual
Hypertension, Pregnancy-Induced
Pregnancy Complications
Abortion, Spontaneous