Exploring immune responses in a rare pregnancy complication
Exploration of Allograft Humoral Rejection in Chronic Histiocytic Intervillositis
This study is trying to understand how the immune system affects a rare pregnancy complication called chronic histiocytic intervillositis, by looking at samples from mothers who have experienced this issue and comparing them to those with normal pregnancies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Clamart) |
| Trial ID | NCT05936333 on ClinicalTrials.gov |
What this trial studies
This study investigates chronic histiocytic intervillositis (CHI), a rare pregnancy condition linked to severe complications like intrauterine growth retardation and miscarriage. The research aims to understand the role of maternal alloantibodies against fetal HLA antigens, which may mimic an allograft rejection process. By analyzing biological samples from affected mothers and their pregnancies, the study seeks to provide insights into the underlying mechanisms of CHI and improve treatment approaches. Participants will include mothers with a history of CHI and related complications, as well as those with normal pregnancies for comparison.
Who should consider this trial
Good fit: Ideal candidates include mothers with a history of chronic histiocytic intervillositis or related obstetrical complications, as well as those with normal pregnancies for comparative analysis.
Not a fit: Patients without a history of pregnancy complications or those not meeting the specific eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and management of chronic histiocytic intervillositis, potentially reducing the risk of severe pregnancy complications.
How similar studies have performed: While the specific approach of this study is novel, previous research has indicated potential success in understanding alloimmune responses in similar conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Clamart
- Antoine Béclère Hospital — Clamart, France (Recruiting)
Study contacts
- Principal investigator: Alexandra LETOURNEAU, Doctor — APHP, Antoine Béclère Hospital, CLAMART, France
- Study coordinator: Alexandra LETOURNEAU, Doctor
- Email: letourneau.alexandra@aphp.fr
- Phone: 331 45 37 44 76
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.