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

Miscarriage Clinical Trial

— FALCO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05557201
• Other study ID #: APHP220747
• Status: Not yet recruiting
• Start date: October 2022
• Est. completion date: October 2025

Study information

• Verified date: September 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Arsene MEKINIAN, MD, PhD
• Phone: 1 71 97 07 65
• Email: arsene.mekinian[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: October 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Abortion, Habitual
• Abortion, Spontaneous
• Miscarriage

Intervention

Biological:
• Lymphocyte immunophenotyping
If the patient accepts the ancillary study, a blood sample will be taken (1 EDTA tube of 3 ml and 2 lithium heparin tubes of 10 mL each) for lymphocyte immunophenotyping in flow cytometry on fresh blood and for the constitution of the biological collection (plasma/mononuclear cells).

Locations

Country	Name	City	State
France	Internal medicine department, hospital Saint Antoine	Paris

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	To build a cohort of patients in order to describe clinical characteristics, tests carried out and medical care of patients presenting spontaneous recurrent miscarriages	Description of clinical and biological characteristics of patients presenting spontaneous recurrent miscarriages	through study completion, an average of 5 years
Secondary	To describe the frequency of miscarriage recidivism	Proportion of recidivism according to number of previous miscarriages, etiologic investigation, age of conception, associated infertility factors, type of miscarriages with or without alive children and different treatments carried out.	for the length of the study
Secondary	To compare the efficacy of immunomodulatory drugs (corticosteroids, hydroxycholoroquin, Intravenous Immunoglobulin Therapy, intralipids, biotherapies)	Description of the efficacy of the various drugs : number of full term pregnancies	through study completion, an average of 5 years
Secondary	To evaluate the psychological state of patients and the impact on pregnancy	Evaluation of the patients' lifestyle using the Baecke questionnaire and medical interrogation.	through study completion, an average of 5 years
Secondary	to evaluate patients' lifestyle and the impact on pregnancy	through study completion, an average of 5 years	evaluation of the patients' lifestyle using the Baecke questionnaire and medical interrogation.