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
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Marie-Laure Gervais
- Phone Number: +33 299282555
- Email: marie-laure.gervais@chu-rennes.fr
Study Locations
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-
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Rennes, France
- Recruiting
- CHU Rennes
-
Contact:
- Marion Mercier
- Phone Number: +33 299284321
- Email: marion.mercier@chu-rennes.fr
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Principal Investigator:
- Marion Mercier, Md
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Patient
|
cell free fetal DNA analysis |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Psychological distress score
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. |
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Long term Psychological distress score
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. |
12 months
|
|
Rate of balanced chromosomal abnormalities in a parent
Time Frame: 8 weeks
|
Number of parents with a chromosomal rearrangement that explains the occurrence of an early miscarriage |
8 weeks
|
|
Number of modified care pathways
Time Frame: 12 months
|
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
Time Frame: 12 months
|
Number of pregnancies and scalability during the year, according to care pathways and NIPT results |
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Marion Mercier, Md, Rennes University Hospital
- Study Chair: Vincent LAVOUE, Pr, Rennes University Hospital
- Study Chair: Sylvie JAILLARD, Rennes University Hospital
- Study Chair: Erika LAUNAY, Rennes University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 35RC25_8835_10_GRACE
- 35RC25_8835_10_GRACE (Other Grant/Funding Number: CHU Rennes)
- 2026-A00248-43 (Other Identifier: ID-RCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
IPD Sharing Time Frame
Data availability after the primary publication of the results and until the database is deleted
IPD Sharing Access Criteria
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.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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