Study of the Role of Tissular Maternofetal Alloimmunization in Placentation Pathologies

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by University Hospital, Limoges.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT00456118
First received: April 3, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted

April 3, 2007
April 3, 2007
September 2006
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No Changes Posted
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Study of the Role of Tissular Maternofetal Alloimmunization in Placentation Pathologies
Study of the Role of Tissular Maternofetal Alloimmunization in Placentation Pathologies

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.

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Observational
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
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  • Recurrent Pregnancy Losses
  • Preeclampsia
  • Intervillositis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
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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
Female
18 Years to 45 Years
No
Contact: Vincent GUIGONIS, MD 05 55 05 68 67 vincent.guigonis@chu-limoges.fr
France
 
NCT00456118
I06014
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University Hospital, Limoges
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Principal Investigator: Vincent GUIGONIS, MD University Hospital, Limoges
University Hospital, Limoges
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP