Cohort of Patients Presenting Unexplained Recurrent Miscarriages and Identification of Early Miscarriage Recidivism Factors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Miscarriage, Early Pregnancy Loss. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
About 1 to 3% of women of childbearing age suffer repeated early spontaneous miscarriages (RCF) defined by at least 3 fetal losses before 14 weeks of gestation. RCFs may be linked 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 non-conventional antiphospholipid antibodies, remains to be established. Indeed half of RCF cases are thought to 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 performed routinely in France in women presenting with recurrent early miscarriages. When one of these known causes is excluded, it is unexplained RCF which represents 50% of RCF. Over half of these women with RCF may be linked to aneuploidies and primary spontaneous recurrent abortions. Assessing the degree of aneuploidy and the genetic origin of foetal losses remains difficult to date, as examination of the miscarriage product is rarely available, due to the spontaneous nature of the loss. An implantation failure (IF) is defined as the absence of pregnancy following the transfer of a good-quality embryo into the uterine cavity. These implantation failures can be due to embryonic factors, maternal factors, or caused by inappropriate stimulation and/or difficult transfers. In the literature, recurrent implantation failure (RIF) is defined as the absence of pregnancy after 3 attempts of transferring good-quality embryos, taking maternal age into account Setting up a prospective cohort of patients with RFC is an essential step in exploring the aetiological factors of RCF and in order to enable better treatment.
Detailed description
The study population will be followed as part of routine care, in the same way as all patients presenting with RPL, in internal medicine or obstetrics-gynecology.
On the day of inclusion, the patient's medical history will be reviewed (demographic data, lifestyle factors, medical and obstetric-gynecologic history, biological tests performed).
Data for each of the patient's pregnancies will also be collected (date of pregnancy onset, type of pregnancy, pregnancy outcome, treatments taken during pregnancy, maternal/fetal complications during pregnancy).
Primary outcome measures
- To build a cohort of patients in order to describe clinical characteristics, tests carried out and medical care of patients presenting spontaneous recurrent miscarriages [Time frame: through study completion, an average of 5 years]
Secondary outcome measures (5)
- To describe the recurrence rate of repeated early pregnancy loss [Time frame: Through study completion, an average of 5 years]
- To describe the recurrence rate of repeated implantation failure [Time frame: Through study completion, an average of 5 years]
- To compare the efficacy of immunomodulatory drugs (corticosteroids, hydroxycholoroquin, Intravenous Immunoglobulin Therapy, intralipids, biotherapies) [Time frame: through study completion, an average of 5 years]
- To evaluate the psychological state of patients and the impact on pregnancy [Time frame: through study completion, an average of 5 years]
- to evaluate patients' lifestyle and the impact on pregnancy [Time frame: evaluation of the patients' lifestyle using the Baecke questionnaire and medical interrogation.]
Eligibility criteria
Inclusion criteria
- Age 18 to 50 years
- Patients who have had 3 (or more) early pregnancy losses occurring before 14 weeks of amenorrhea and/or at least 3 implantation failures.
- Patients who have been informed and have not objected to participating in the study.
- Patients covered by a social security system.
Exclusion criteria
- patients who do not agree the use of their data
- Patients on AME
- Patients under legal protection
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Internal medicine department, hospital Saint Antoine — Paris
Publications
- Dernoncourt A, Hedhli K, Abisror N, Cheloufi M, Cohen J, Kolanska K, McAvoy C, Selleret L, Ballot E, Mathieu d'Argent E, Chabbert Buffet N, Fain O, Kayem G, Mekinian A. Hydroxychloroquine in recurrent pregnancy loss: data from a French prospective multicenter registry. Hum Reprod. 2024 Sep 1;39(9):1934-1941. doi: 10.1093/humrep/deae146. PMID 38942601
Identifiers
NCT: NCT05557201 · APHP220747 · IDRCB 2022-A00273-40