An interventional study of Biological collection in Chronic Histiocytic Intervillositis, Intrauterine Growth Retardation and Fetal Death in Utero, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-06.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Basic science
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.
268 studies on the registry are indexed under Fetal Growth Retardation; 67 are open to participants now.
This study's planned enrollment of 200 is above the median of 103 across 119 interventional studies indexed under Fetal Growth Retardation.
Browse Fetal Growth Retardation studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,578 studies on the registry; 1,030 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Family Inclusion Criteria:
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:
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
Procedure: Biological collection
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
Procedure: Biological collection
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
Procedure: Biological collection
up to 25 mL of blood collection for the adults and saliva collection for the minor at inclusion, and placenta collection at childbirth
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.
Time frame: up to 6 months
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.
Time frame: 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
Time frame: up to 6 months
measure of semi-quantitative graduation of C4d in placenta compared to percentage of villositis
Time frame: up to 6 months
measure of semi-quantitative graduation of CD68+ infiltrate in placenta compared to surface and number of involved villositis
Time frame: 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
Time frame: 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
Time frame: up to 6 months
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2023 (actual). Primary completion is estimated for Oct 2025, 24 months after the start.
Of 39 non-industry interventional studies with no phase under Fetal Growth Retardation, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 48. This study's planned 24 months is below that.
Counting every sponsor, half of 40 studies reached it within 35 months; a quarter within 13 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
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