Actively Recruiting
Exploration of Allograft Humoral Rejection in Chronic Histiocytic Intervillositis
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2024-11-06
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Chronic histiocytic intervillositis (CHI) is a rare pregnancy condition affecting about 5 in 10,000 pregnancies. It involves inflammatory lesions in the placenta that can cause serious pregnancy problems like growth delays, fetal death, and miscarriage. The exact causes of CHI are not well understood, and current treatments are challenging and often ineffective. Recent research suggests an immune response against the fetus may be involved, similar to organ transplant rejection, and this study aims to explore this further and predict risks of fetal loss. The study involves three groups: patients with CHI, patients with antiphospholipid syndrome (APS), and women with normal pregnancies. Researchers will collect blood samples from the parents, saliva or blood from their children, and placental tissue at childbirth. These biological samples will help analyze immune responses and placental changes related to CHI and other pregnancy outcomes. Participants will provide samples at inclusion and childbirth, which will be examined for immune markers, antibody levels, and placental changes. The main focus is to determine how often CHI shows signs of immune rejection and to study links between antibody levels and pregnancy complications like growth retardation and fetal death. The study will measure various immune and placental markers up to six months after sample collection to better understand CHI's mechanisms.
CONDITIONS
Brief Title
Exploration of Allograft Humoral Rejection in Chronic Histiocytic Intervillositis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Mother and father aged 18 years or older
- Mothers in the CHI group must have a history of normal pregnancy or obstetrical complications such as IUGR, fetal death, miscarriage, or abortion, with CHI diagnosis confirmed by placental examination
- Mothers in the antiphospholipid syndrome group must have a history of miscarriages and confirmed antiphospholipid syndrome
- Mothers in the normal pregnancy group must have a third consecutive full-term pregnancy with a healthy child
- Consent from mother and father for participation of at least one child or use of existing samples from previous pregnancies
- Father must be the biological parent of the last pregnancy and children participating in the study
You will not qualify if you...
- Mothers in the normal pregnancy group with suspected or confirmed intra-amniotic infection
- Any mother with a history of blood transfusion
- Any mother with a history of allogeneic organ transplantation
- Mother or father under legal protection such as guardianship or curatorship
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants provide blood, saliva, and placenta samples for analysis related to chronic histiocytic intervillositis and other pregnancy conditions.
Sample collection at inclusion and at childbirth
Trial Site Locations
Total: 1 location
1
Antoine Béclère Hospital
Clamart, France
Actively Recruiting
Research Team
A
Alexandra LETOURNEAU, Doctor
A
Alexandra BENACHI, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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