Miscarriage in First TrimesterGRACENCT07639333
GRACE - Genetic Insights Into Early pRegnancy Loss Using Cell-free fEtal DNA
A study testing Non invasive prenatal test in people with Miscarriage in First Trimester and Prenatal Genetic Diagnosis, run by Rennes University Hospital at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Miscarriage in First Trimester, Prenatal Genetic Diagnosis
- What is being tested?
- Non invasive prenatal test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 11 Sep 2026to Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 43 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Rennes
Rennes
Marion Mercier, 299284321 ext. +33, marion.mercier@chu-rennes.fr
Marion Mercier, Md
About this study
Official title: 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
Read the 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.
- Being tested
- Non invasive prenatal test
- Keywords
- early miscarriage, miscarriage, prenatal diagnosis, prenatal test, cell free fetal DNA, chromosomal abnomarlities
- Medical subject headings
- Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non invasive prenatal testGenetic
cell free fetal DNA analysis
| Study group | Role | What they receive |
|---|---|---|
| Patient | Experimental | Not described Receives: Genetic: Non invasive prenatal test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (4)
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.
Measured: 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
Measured: 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
Measured: 12 months
Number of pregnancies
Number of pregnancies and scalability during the year, according to care pathways and NIPT results
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start11 Sep 2026
- Primary completionMar 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Miscarriage in First TrimesterStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marion Mercier, Md, Study director, Rennes University HospitalVincent LAVOUE, Pr, Study chair, Rennes University HospitalSylvie JAILLARD, Study chair, Rennes University HospitalErika LAUNAY, Study chair, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07639333
- Sponsor's protocol ID
- 35RC25_8835_10_GRACE
- Other IDs
- 35RC25_8835_10_GRACE, 2026-A00248-43
- Acronym
- GRACE
- Status last verified
- Oct 2026
- First submitted
- 5 Jun 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GRACE - Genetic Insights Into Early pRegnancy Loss: A Prospective Study Using Cell-free fEtal DNA
- ClinicalTrials.gov ID
- NCT07639333
- Acronym / sponsor ID
- GRACE / 35RC25_8835_10_GRACE
- Keywords
- early miscarriage, miscarriage, prenatal diagnosis, prenatal test, cell free fetal DNA, chromosomal abnomarlities
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 11 Sep 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient | Experimental | Genetic: Non invasive prenatal test |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non invasive prenatal testcell free fetal DNA analysis | Genetic | Patient |
Primary outcome
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.
4 secondary outcomes
Long term Psychological distress score
Time frame: 12 months
Rate of balanced chromosomal abnormalities in a parent
Time frame: 8 weeks
Number of modified care pathways
Time frame: 12 months
Number of pregnancies
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marion Mercier, Md study director
Rennes University Hospital
Vincent LAVOUE, Pr study chair
Rennes University Hospital
Sylvie JAILLARD study chair
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non invasive prenatal test in people with Miscarriage in First Trimester and Prenatal Genetic Diagnosis, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie-Laure Gervais (299282555 ext. +33, marie-laure.gervais@chu-rennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological distress score (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.