Miscarriage in First Trimester, Prenatal Genetic Diagnosis
Conditions
Keywords
early miscarriage, miscarriage, prenatal diagnosis, prenatal test, cell free fetal DNA, chromosomal abnomarlities
Brief summary
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
Detailed description
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.
Interventions
GENETICNon invasive prenatal test
cell free fetal DNA analysis
Sponsors
Rennes University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
Patient can refuse to know the result of NIPT
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 43 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psychological distress score | 8 weeks | HADS (Hospital Anxiety and Depression Scale) and PGS (Perinatal Grief Scale) scores. The impact of the NIPT results will be analyzed in relation to these scores, which will be combined into a composite score of psychological distress. HADS questionnaire : Each item is rated on a four-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represents 'borderline' and 0-7 'normal' The PGS is a self-report questionnaire designed to assess the emotional and psychological impact of perinatal loss, including miscarriage, stillbirth, or neonatal death. The more the score is high, the more the grief is intense. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Long term Psychological distress score | 12 months | HADS (Hospital Anxiety and Depression Scale) and PGS (Perinatal Grief Scale) at 1 year. The impact of the DPNI results will be analyzed in relation to these scores, which will be combined into a composite score of psychological distress. HADS questionnaire : Each item is rated on a four-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represents 'borderline' and 0-7 'normal' The PGS is a self-report questionnaire designed to assess the emotional and psychological impact of perinatal loss, including miscarriage, stillbirth, or neonatal death. The more the score is high, the more the grief is intense. |
| Rate of balanced chromosomal abnormalities in a parent | 8 weeks | Number of parents with a chromosomal rearrangement that explains the occurrence of an early miscarriage |
| Number of modified care pathways | 12 months | Number of modified care pathways based on the patient's etiology and the NIPT results during the year after miscarriages |
| Number of pregnancies | 12 months | Number of pregnancies and scalability during the year, according to care pathways and NIPT results |
Countries
France
Contacts
CONTACTMarie-Laure Gervais
STUDY_DIRECTORMarion Mercier, Md
Rennes University Hospital
STUDY_CHAIRVincent LAVOUE, Pr
Rennes University Hospital
STUDY_CHAIRSylvie JAILLARD
Rennes University Hospital
STUDY_CHAIRErika LAUNAY
Rennes University Hospital
Outcome results
None listed