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| ID | Type | Description | Link |
|---|---|---|---|
| 35RC25_8835_10_GRACE | Other Grant/Funding Number | CHU Rennes | |
| 2026-A00248-43 | Other Identifier | ID-RCB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non invasive prenatal test | Genetic | cell free fetal DNA analysis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Psychological distress score | 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. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Long term Psychological distress score | 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. |
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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
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marie-Laure Gervais | Contact | 299282555 | +33 | marie-laure.gervais@chu-rennes.fr |
| Name | Affiliation | Role |
|---|---|---|
| Marion Mercier, Md | Rennes University Hospital | Study Director |
| Vincent LAVOUE, Pr | Rennes University Hospital | Study Chair |
| Sylvie JAILLARD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Rennes | Rennes | France |
|
All of the individual participant data collected during the trial will be available, after the primary publication of the results, to any researchers who provide a methodologically sound proposal. Proposals should be directed to dri@chu-rennes.fr. To gain access, data requestors will need to sign a data access agreement; depending on the case, additional formalities may be required.
Data availability after the primary publication of the results and until the database is deleted
Any researchers who provide a methodologically sound proposal will be able to access the IPD ans supporting information. To gain access, data requestors will need to sign a data access agreement; depending on the case, additional formalities may be required.
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| ID | Term |
|---|---|
| D000022 | Abortion, Spontaneous |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Patient can refuse to know the result of NIPT
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| 12 months |
| Rate of balanced chromosomal abnormalities in a parent | Number of parents with a chromosomal rearrangement that explains the occurrence of an early miscarriage | 8 weeks |
| Number of modified care pathways | Number of modified care pathways based on the patient's etiology and the NIPT results during the year after miscarriages | 12 months |
| Number of pregnancies | Number of pregnancies and scalability during the year, according to care pathways and NIPT results | 12 months |
| Rennes University Hospital |
| Study Chair |
| Erika LAUNAY | Rennes University Hospital | Study Chair |