Clinical trial NCT05557201: Cohort of Patients Presenting Unexplained Recurrent Miscarriages and Identification of Early Miscarriage Recidivism Factors
Official title: Cohort of Patients Presenting Unexplained Recurrent Miscarriages and Identification of Early Miscarriage Recidivism Factors
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Miscarriage
Keywords: Miscarriage
Prognostic factors
Biological collection
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-09-27
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with recurrent early miscarriages ( at least 3 before 14 weeks of gestation)

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Age 18 to 50 years
* Patients with at least 3 recurrent miscarriages
* Signed consent form

Exclusion Criteria:

- Patients who don't accept the use of their data

Primary outcomes:
measure: To build a cohort of patients in order to describe clinical characteristics, tests carried out and medical care of patients presenting spontaneous recurrent miscarriages
timeFrame: through study completion, an average of 5 years
Secondary outcomes:
measure: To describe the frequency of miscarriage recidivism
timeFrame: for the length of the study
measure: To compare the efficacy of immunomodulatory drugs (corticosteroids, hydroxycholoroquin, Intravenous Immunoglobulin Therapy, intralipids, biotherapies)
timeFrame: through study completion, an average of 5 years
measure: To evaluate the psychological state of patients and the impact on pregnancy
timeFrame: through study completion, an average of 5 years
measure: to evaluate patients' lifestyle and the impact on pregnancy
timeFrame: evaluation of the patients' lifestyle using the Baecke questionnaire and medical interrogation.
Other outcomes:
Locations:
city: Paris
country: France
facility: Internal medicine department, hospital Saint Antoine
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Arsene MEKINIAN, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: