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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 : Completed
First Posted : April 4, 2007
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
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

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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 : September 2006
Actual Primary Completion Date : July 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine


Group/Cohort
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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
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


Locations
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France
Bordeaux University Hospital
Bordeaux, France, 33076
LIMOGES University Hospital
Limoges, France, 87042
Saint Antoine Hospital
Paris, France, 75012
Tenon Hospital
Paris, France, 75020
Trousseau Hospital
Paris, France, 75571
South Reunion Hospital
Saint Pierre, France, 97448
Toulouse University Hospital
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Limoges
Investigators
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Principal Investigator: Vincent GUIGONIS, MD University Hospital, Limoges
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Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT00456118    
Other Study ID Numbers: I06014
First Posted: April 4, 2007    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: May 2009
Keywords provided by University Hospital, Limoges:
recurrent pregnancy losses
preeclampsia
intervillositis
maternofetal alloimmunization
Additional relevant MeSH terms:
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Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications