GRACE - Genetic Insights Into Early pRegnancy Loss Using Cell-free fEtal DNA (GRACE)
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
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Marie-Laure Gervais
- Numero di telefono: +33 299282555
- Email: marie-laure.gervais@chu-rennes.fr
Luoghi di studio
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Rennes, Francia
- Reclutamento
- CHU Rennes
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Contatto:
- Marion Mercier
- Numero di telefono: +33 299284321
- Email: marion.mercier@chu-rennes.fr
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Investigatore principale:
- Marion Mercier, Md
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
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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)
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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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Diagnostico
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Paziente
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cell free fetal DNA analysis |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Psychological distress score
Lasso di tempo: 8 weeks
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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
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Long term Psychological distress score
Lasso di tempo: 12 months
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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. |
12 months
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Rate of balanced chromosomal abnormalities in a parent
Lasso di tempo: 8 weeks
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Number of parents with a chromosomal rearrangement that explains the occurrence of an early miscarriage |
8 weeks
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Number of modified care pathways
Lasso di tempo: 12 months
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Number of modified care pathways based on the patient's etiology and the NIPT results during the year after miscarriages |
12 months
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Number of pregnancies
Lasso di tempo: 12 months
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Number of pregnancies and scalability during the year, according to care pathways and NIPT results |
12 months
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Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Marion Mercier, Md, Rennes University Hospital
- Cattedra di studio: Vincent LAVOUE, Pr, Rennes University Hospital
- Cattedra di studio: Sylvie JAILLARD, Rennes University Hospital
- Cattedra di studio: Erika LAUNAY, Rennes University Hospital
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 35RC25_8835_10_GRACE
- 35RC25_8835_10_GRACE (Altro numero di sovvenzione/finanziamento: CHU Rennes)
- 2026-A00248-43 (Altro identificatore: ID-RCB)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
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.
Periodo di condivisione IPD
Data availability after the primary publication of the results and until the database is deleted
Criteri di accesso alla condivisione IPD
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.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
- CODICE_ANALITICO
- RSI
Informazioni su farmaci e dispositivi, documenti di studio
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