Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Chronic histiocytic intervillositis (CHI) is a rare condition with an incidence of 5 in 10,000 pregnancies. This rare condition is associated with placental inflammatory lesions leading to severe and recurrent obstetrical complications: intrauterine growth retardation (IUGR), fetal death in utero and miscarriage. The pathophysiological mechanisms of CHI are poorly understood, while the empirical treatments prescribed to prevent recurrence are cumbersome and of poor efficacy.
Recent findings suggest that an alloimmune response may play a role. In a recent work, the investigators have demonstrated the role of maternal alloantibodies directed against fetal HLA antigens in two patients followed for recurrent IUGR associated with CHI. Their work suggests that a humoral alloimmune response directed against fetal HLA antigens mimics an allograft rejection process.
The investigators propose to extend the preliminary results obtained in these patients to provide new insights into the pathophysiological mechanisms of CHI, and eventually to predict the risks of fetal loss.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient with chronic histiocytic intervillositis | Experimental | Patient with CHI, as well as her children and their father. Blood collection from the parents, saliva collection (or blood collection) from the children, placenta collection |
|
| patients with anti-phospholipid syndromes (APS) | Active Comparator | Patient with antiphospholipid syndrome, as well as her children and their father. Blood collection from the parents, saliva collection (or blood collection) from the children, placenta collection |
|
| women with a third full-term pregnancy without growth retardation. | Placebo Comparator | Patient with normal pregnancies, as well as her children and their father. Blood collection from the parents, saliva collection (or blood collection) from the children, placenta collection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biological collection | Procedure | up to 25 mL of blood collection for the adults and saliva collection for the minor at inclusion, and placenta collection at childbirth |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients diagnosed with CHI, defined by the concomitant presence of the 3 criteria required to evoke humoral alloimmune rejection for this pathology | Proportion of patients diagnosed with CHI, defined by the concomitant presence of the 3 criteria required to evoke humoral alloimmune rejection for this pathology, namely CD68+ infiltrate, AND C4d deposits on the trophoblastic villi AND the presence of at least one FSA (fetus-specific antibody, directed against fetal HLA antigens in the maternal blood) with an elevated level, defined by a Mean Fluorescence Intensity (MFI) > 10,000). This proportion of patients observed in CHI carriers will be compared to the proportion of patients with the concomitant presence of the same 3 criteria observed in the other two control groups. | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| To measure the FSA levels by Mean Fluorescence Intensity for the different obstetrical complications: intrauterine growth retardation (IUGR), fetal death in utero and abortion for IUGR. | up to 6 months | |
| to measure the correlation between fetus-specific antibody level by Mean Fluorescence Intensity and the severity and/or precocity of obstetrical complications |
Not provided
Family Inclusion Criteria:
Mother and father ≥ 18 years old
For mothers in the CHI group :
For the mothers of the antiphospholipid syndrom group
For mothers in the normal pregnancy group:
For the mother and father:
o Consent to participate in the study and for the participation in the study of at least one child and/or the use of existing samples (placenta / fetal DNA) from at least one previous pregnancy with CHI for the CHI group or at least one previous miscarriage for the APS group
For the father:
o Father of the last pregnancy and of the child(ren) participating in the study
Exlusion criteria :
For mothers in the normal pregnancy group:
o Suspected or confirmed intra-amniotic infection
For all the mothers:
For the mother and the father:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexandra LETOURNEAU, Doctor | Contact | 331 45 37 44 76 | letourneau.alexandra@aphp.fr | |
| Alexandra BENACHI, Professor | Contact | 331 45 37 44 76 | alexandra.benachi@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Alexandra LETOURNEAU, Doctor | APHP, Antoine Béclère Hospital, CLAMART, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antoine Béclère Hospital | Recruiting | Clamart | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005317 | Fetal Growth Retardation |
| D050497 | Stillbirth |
| D000022 | Abortion, Spontaneous |
| ID | Term |
|---|---|
| D005315 | Fetal Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| up to 6 months |
| measure of semi-quantitative graduation of C4d in placenta compared to percentage of villositis | up to 6 months |
| measure of semi-quantitative graduation of CD68+ infiltrate in placenta compared to surface and number of involved villositis | up to 6 months |
| To measure the expression of HLA class I and II molecules by placental villi by ß2-microglobulin and HLA-DR labelling | up to 6 months |
| Epitope analysis with algorithm developped by laboratoire HLA de St Louis (Pr JL Taupin) | Epitope analysis with algorithm developped by laboratoire HLA de St Louis (Pr JL Taupin) to determine whether an antibody response against a limited number of epitopes present during a first pregnancy that resulted in a healthy child can explain immunization against both paternal alleles | up to 6 months |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006130 | Growth Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005313 | Fetal Death |
| D003643 | Death |