Study of the Role of Tissular Maternofetal Alloimmunization in Placentation Pathologies

NCT ID: NCT00456118

Last Updated: 2018-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

83 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-09-30

Study Completion Date

2009-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Recurrent Pregnancy Losses Preeclampsia Intervillositis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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repeated miscarriages

60 womens for repeated miscarriages will be included

No interventions assigned to this group

Preeclampsia

70 women for pre-eclampsia will be included

No interventions assigned to this group

intervillites

20 women for intervillites will be included

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Limoges

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vincent GUIGONIS, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Limoges

Locations

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Bordeaux University Hospital

Bordeaux, , France

Site Status

LIMOGES University Hospital

Limoges, , France

Site Status

Saint Antoine Hospital

Paris, , France

Site Status

Tenon Hospital

Paris, , France

Site Status

Trousseau Hospital

Paris, , France

Site Status

South Reunion Hospital

Saint-Pierre, , France

Site Status

Toulouse University Hospital

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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I06014

Identifier Type: -

Identifier Source: org_study_id

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