GRACE - Genetic Insights Into Early pRegnancy Loss Using Cell-free fEtal DNA

GRACE - Genetic Insights Into Early pRegnancy Loss: A Prospective Study Using Cell-free fEtal DNA

The aim of this study is to assess the impact of non-invasive prenatal testing right after an early isolated miscarriage on mental health and on the patient's subsequent care in the year following the miscarriage

A blood sample will be added to primary care at the time of diagnosis of early miscarriage to realise non-invasive prenatal testing (NIPT). NIPT will be done on cell-free fetal DNA present in woman's blood to detect potential chromosomal abnormalities. At the 8-week consultation, the results will be shared with the patient if she so wishes. During this appointment, two questionnaires designed to assess her psychological state in relation to the miscarriage (HAD and PGS) will be completed. Depending on the patient's medical history and the results of the NIPT, a tailored care plan may be proposed. At the one-year follow-up appointment, the same questionnaires will be completed and a review will be carried out of the care proposed and provided, as well as the couple's future reproductive plans.

Inclusion Criteria:

• A stopped pregnancy with an intrauterine pregnancy diagnosed by ultrasound (embryo larger than 7 mm corresponding to a gestational age of 6 weeks and 5 days. This is justified by the fact that fetal fragment (FF) detection is possible at 5 weeks of gestation, or 7 weeks and 5 days)

• Expulsion of a pregnancy within the last 2 hours

  • Patient fluent in French
  • Enrolled in a social security program
  • Has received oral and written information about the protocol and has signed a consent form to participate in this research.

Exclusion Criteria:

• Diagnosis of an empty gestational sac, ectopic pregnancy, or unknown location
• Ultrasound findings consistent with a molar pregnancy
• Identified cause (preimplantation diagnosis, multiple uterine fibroids or a single fibroid > 5 cm, uterine malformation affecting the uterine cavity, lupus, and antiphospholipid syndrome)
• Inability to obtain a blood sample
• Known current malignant tumor
• Blood transfusions within the last 3 months
• Cell therapy or immunotherapy within the last 3 months
• Previous organ transplant