Study of the Role of Tissular Maternofetal Alloimmunization in Placentation Pathologies

Preeclampsia Clinical Trial

Official title:

Study of the Role of Tissular Maternofetal Alloimmunization in Placentation Pathologies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00456118
• Other study ID #: I06014
• Status: Completed
• Start date: September 2006
• Est. completion date: December 2009

Study information

• Verified date: May 2009
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: December 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Abortion, Habitual
• Intervillositis
• Pre-Eclampsia
• Preeclampsia
• Recurrent Pregnancy Losses

Locations

Country	Name	City	State
France	Bordeaux University Hospital	Bordeaux
France	LIMOGES University Hospital	Limoges
France	Saint Antoine Hospital	Paris
France	Tenon Hospital	Paris
France	Trousseau Hospital	Paris
France	South Reunion Hospital	Saint Pierre
France	Toulouse University Hospital	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France,