Early Pregnancy Loss, Miscarriage
Conditions
Keywords
Miscarriage, Prognostic factors, Biological collection, recurrent early pregnancy losses, repeated implantation failure
Brief summary
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).
Interventions
None listed
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To build a cohort of patients in order to describe clinical characteristics, tests carried out and medical care of patients presenting spontaneous recurrent miscarriages | through study completion, an average of 5 years | Description of the clinical and biological characteristics of patients with recurrent early pregnancy losses and/or recurrent implantation failures |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To describe the recurrence rate of repeated early pregnancy loss | Through study completion, an average of 5 years | Proportion of recurrence of early pregnancy loss (EPL) over the entire duration of the study: according to the number of previous early pregnancy losses; according to abnormalities found in the etiological work-up; according to age at onset, associated infertility, type of pregnancy loss with or without live children, and according to the different treatments used |
| To describe the recurrence rate of repeated implantation failure | Through study completion, an average of 5 years | Proportion of recurrence of RIF over the entire duration of the study: according to the number of previous implantation failures, according to abnormalities found in the etiological work-up, according to age at onset, associated infertility, and according to the different treatments used |
| To compare the efficacy of immunomodulatory drugs (corticosteroids, hydroxycholoroquin, Intravenous Immunoglobulin Therapy, intralipids, biotherapies) | through study completion, an average of 5 years | Description of the efficacy of the various drugs : number of full term pregnancies |
| To evaluate the psychological state of patients 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. |
| to evaluate patients' lifestyle 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 |
Countries
France
Contacts
Primary ContactArsene MEKINIAN, MD, PhD
Outcome results
None listed