Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05936333
Other study ID # APHP221169
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 2023
Est. completion date January 2025

Study information

Verified date June 2023
Source Assistance Publique - Hôpitaux de Paris
Contact Alexandra LETOURNEAU, Doctor
Phone 331 45 37 44 76
Email letourneau.alexandra@aphp.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date January 2025
Est. primary completion date January 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Intervention

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

Locations

Country Name City State
France Antoine Béclère Hospital Clamart

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
up to 6 months
Secondary 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. up to 6 months
Secondary to measure the correlation between fetus-specific antibody level by Mean Fluorescence Intensity and the severity and/or precocity of obstetrical complications up to 6 months
Secondary measure of semi-quantitative graduation of C4d in placenta compared to percentage of villositis up to 6 months
Secondary measure of semi-quantitative graduation of CD68+ infiltrate in placenta compared to surface and number of involved villositis up to 6 months
Secondary To measure the expression of HLA class I and II molecules by placental villi by ß2-microglobulin and HLA-DR labelling up to 6 months
Secondary 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 up to 6 months
See also
  Status Clinical Trial Phase
Recruiting NCT05969574 - Is Decreased Ovarian Reserve Related to an Increased Number of Previous Early Miscarriages?
Enrolling by invitation NCT01689428 - Ism1 Versus EmbryoGen Media for Embryo Culture in Previous Pregnancy Loss Cases Phase 3
Completed NCT00194844 - Couples Miscarriage Healing Project:Randomized Trial Phase 1/Phase 2
Recruiting NCT05789940 - Hysteroscopy vs. Endouterine Aspiration in the Management of Trophoblastic Retention N/A
Recruiting NCT03628625 - Letrozole Pretreatment With Misoprostol fInduction of Abortion In First-Trimester Missed Miscarriage Phase 2
Not yet recruiting NCT05557201 - Cohort of Patients Presenting Unexplained Recurrent Miscarriages and Identification of Early Miscarriage Recidivism Factors
Not yet recruiting NCT05579756 - Psychatric Impact of Miscarriage in Assiut University Hospital
Not yet recruiting NCT05039853 - Improving Mental Health Following Early PREgnancy Loss Using a Brief Cognitive Task N/A
Recruiting NCT01223482 - A Study Looking at Women's Experiences After a Miscarriage N/A
Completed NCT04604366 - Comparison of Vaginal Versus Sublingual Misoprostol in the Treatment of First Trimester Missed Miscarriage Phase 2
Not yet recruiting NCT05088720 - Misoprostol for Management of Women With an Incomplete Miscarriage N/A
Not yet recruiting NCT05094375 - Vaginal Misoprostol In Medical Treatment of First Trimester Missed Miscarriage N/A
Not yet recruiting NCT05103098 - Sublingual Misoprostol In Medical Treatment of First Trimester Missed Miscarriage N/A
Not yet recruiting NCT05088707 - Sublingual Versus Vaginal Misoprostol In Medical Treatment of Second Trimestric Missed Miscarriage N/A
Recruiting NCT05304273 - Comparison Between Letrozole and Mifepristone in Medical Termination of First Trimester Miscarriages Phase 3
Not yet recruiting NCT05653414 - Interest of a Short Early Psychological Care in Women With Miscarriage N/A
Recruiting NCT03976544 - Natural Cycle Versus Hormone Replacement Therapy Cycle for a Frozen-thawed Embryo Transfer in PGT Patients Phase 4
Completed NCT01916928 - The Use of Cell Free Fetal DNA in the Maternal Blood in the Evaluation of Intrauterine Fetal Demise and Miscarriage N/A
Completed NCT03940495 - Serum Kisspeptin: a Predictive Marker of Miscarriage or Not?
Completed NCT04512820 - Treatment of Missed Miscarriage With TRUCLEAR Tissue Removal System, a Feasiblity Study N/A