CHU Rennes
Rennes, France
Location status: Recruiting
NCT Number: NCT07639333
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
Interested in participating?
Request Info18 year–43 year
Female
Interventional
Not applicable
Rennes, France
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
cell free fetal DNA analysis
Time frame: 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.
Time frame: 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.
Time frame: 8 weeks
Number of parents with a chromosomal rearrangement that explains the occurrence of an early miscarriage
Time frame: 12 months
Number of modified care pathways based on the patient's etiology and the NIPT results during the year after miscarriages
Time frame: 12 months
Number of pregnancies and scalability during the year, according to care pathways and NIPT results
Contact information is provided by the study sponsor or research team.
Rennes University Hospital
Other
GRACE - Genetic Insights Into Early pRegnancy Loss: A Prospective Study Using Cell-free fEtal DNA
Acronym: GRACE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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