Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05936333

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

104 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Exploration of Allograft Humoral Rejection in Chronic Histiocytic Intervillositis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Mother and father 18 years old or older
  • Mothers in the CHI group with a history of normal pregnancy or IUGR, fetal death in utero, miscarriage, or abortion followed by at least one obstetrical complication such as IUGR, fetal death, or miscarriage
  • Diagnosis of chronic histiocytic intervillositis confirmed by placental examination with CD68+ marking for mothers in the CHI group
  • Mothers with antiphospholipid syndrome and history of miscarriage
  • Mothers in the normal pregnancy group with a third consecutive normal pregnancy at term (36 weeks or more) with a healthy child
  • Consent from mother and father to participate in the study and for use of existing samples from previous pregnancies or miscarriages
  • Father must be the father of the last pregnancy and child(ren) participating in the study
Not Eligible

You will not qualify if you...

  • For mothers in the normal pregnancy group: suspected or confirmed intra-amniotic infection
  • For all mothers: history of blood transfusion
  • For all mothers: history of allogeneic organ transplantation
  • For mother and father: persons under legal protection such as guardianship or curatorship

AI-Screening

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Trial Site Locations

Total: 1 location

1

Antoine Béclère Hospital

Clamart, France

Actively Recruiting

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Research Team

A

Alexandra LETOURNEAU, Doctor

CONTACT

A

Alexandra BENACHI, Professor

CONTACT

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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