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Recruiting Not applicable

Exploration of Allograft Humoral Rejection in Chronic Histiocytic Intervillositis

NCT05936333 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2023-10-11
Last updated
2024-11-06

Condition(s) studied

Chronic Histiocytic IntervillositisIntrauterine Growth RetardationFetal Death in UteroMiscarriage

Investigational drug(s) / intervention(s)

Biological collection

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

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Family Inclusion Criteria: * Mother and father ≥ 18 years old * For mothers in the CHI group : * History of a normal pregnancy (full term, alive child) or IUGR/MFIU or miscarriage(s) or abortion followed by at least 1 obstetrical complication such as IUGR, MFIU, miscarriage * Diagnosis of chronic histiocytic intervillitis made by placental anatomopathological examination with CD68+ marking * For the mothers of the antiphospholipid syndrom group * History of miscarriage(s) * Having an anti-phospholipid syndrome * For mothers in the normal pregnancy group: * Third consecutive pregnancy of normal course, at term (≥ 36 weeks of amenorrhea) with eutrophic child 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: * History of blood transfusion * History of allogeneic organ transplantation * For the mother and the father: * Person under legal protection (guardianship, curatorship)

Primary outcome measure(s)

  • Proportion of patients diagnosed with CHI, defined by the concomitant presence of the 3 criteria required to evoke humoral alloimmune rejection for this pathology — up to 6 months
    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.

Trial sites (1)

FacilityCityRegionStatus
Antoine Béclère Hospital Clamart France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05936333 on ClinicalTrials.gov ↗ ← All trials in France