Clinical trial NCT00456118: Study of the Role of Tissular Maternofetal Alloimmunization in Placentation Pathologies
Official title: Study of the Role of Tissular Maternofetal Alloimmunization in Placentation Pathologies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recurrent Pregnancy Losses
Preeclampsia
Intervillositis
Keywords: recurrent pregnancy losses
preeclampsia
intervillositis
maternofetal alloimmunization
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2007-04-04
Enrollment: 83
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Bordeaux University Hospital
city: Limoges
country: France
facility: LIMOGES University Hospital
city: Paris
country: France
facility: Saint Antoine Hospital
city: Paris
country: France
facility: Tenon Hospital
city: Paris
country: France
facility: Trousseau Hospital
city: Saint Pierre
country: France
facility: South Reunion Hospital
city: Toulouse
country: France
facility: Toulouse University Hospital
Study officials:
affiliation: University Hospital, Limoges
name: Vincent GUIGONIS, MD
role: PRINCIPAL_INVESTIGATOR
References: