Cohort of Patients Presenting Unexplained Recurrent Miscarriages and Identification of Early Miscarriage Recidivism Factors — FALCO  

Miscarriage Clinical Trial

Official title: Cohort of Patients Presenting Unexplained Recurrent Miscarriages and Identification of Early Miscarriage Recidivism Factors

Status Not yet recruiting

Clinical Trial Summary

About 1 to 3% of women of childbearing age have repeated early spontaneous miscarriages (RCF) defined by at least 3 fetal losses before 14 weeks of gestation. RCFs may be related to parental chromosomal abnormalities, congenital or acquired uterine abnormalities, hormonal causes (e.g. type 1 and 2 diabetes, ovarian failure), infectious etiology, constitutional or acquired thrombophilia or sickle cell disease.

The presence of antiphospholipid antibodies, antithyroid and anti-transglutaminase antibodies in approximately 10% of cases suggests an autoimmune origin for these fetal losses. The role of other antibodies, in particular unconventional antiphospholipid antibodies, remains to be established. Indeed half of RCF cases would be due to an immunological dysregulation of the mother leading to a decrease in tolerance to the fetus. Several studies have shown immune abnormalities, such as an imbalance of pro and anti-inflammatory cytokines, an increase in cytotoxic cells and a defect in regulatory cells in the blood of patients. The assessment of these immune abnormalities is not currently carried out routinely in France in women with recurrent early miscarriages.

When one of these known causes is excluded, it is unexplained RCF which represents 50% of RCF. In these women with unexplained RCF, slightly more than half could be linked to aneuploidies and primary recurrent spontaneous abortions. The evaluation of the degree of aneuploidy and the genetic origin of fetal losses remains difficult, the examination of the sample of tissue from the miscarriage being rarely available, due to the spontaneous nature of the loss.

The constitution of a prospective cohort of patients with RCF is an essential step in exploring the factors associated with the success of treatment.

Clinical Trial Description

On the day of inclusion, if the patient accepts the ancillary study, a blood sample will be taken for the biological collection If the patient becomes pregnant during the follow-up period, the blood sample for the ancillary study will be repeated each trimester of pregnancy (if applicable).

At the inclusion visit and during pregnancy, the patient will complete a Baecke questionnaire and a questionnaire to measure perceived stress

The study population will be followed as part of usual care, identical to all patients presenting with RCF.

As part of the routine care of the internal medicine department of Saint Antoine, patients with RCF have a complete check-up in the day hospital (complete blood test, stomatologist consultation, ECG) and are seen in consultation twice a year. ;

Related Conditions & MeSH terms

• Abortion, Habitual
• Abortion, Spontaneous
• Miscarriage

• NCT number: NCT05557201
• Study type: Observational
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Arsene MEKINIAN, MD, PhD
• Phone: 1 71 97 07 65
• Email: arsene.mekinian@aphp.fr
• Status: Not yet recruiting
• Start date: October 2022
• Completion date: October 2025