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: Recruiting
• Conditions: Miscarriage in First Trimester; Prenatal Genetic Diagnosis
• Intervention / Treatment: Genetic: Non invasive prenatal test

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: Interventional
• Enrollment (Estimated): 100
• 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

• France
  • Rennes, France
    • Recruiting
    • Chu Rennes
    • Contact: Marion Mercier; Phone Number: +33 299284321; Email: marion.mercier@chu-rennes.fr
    • Principal Investigator: Marion Mercier, Md

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

  • 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)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient	Genetic: Non invasive prenatal test; cell free fetal DNA analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• 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 (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: June 5, 2026
• First Submitted That Met QC Criteria: June 5, 2026
• First Posted (Actual): June 10, 2026

Study Record Updates

• Last Update Posted (Actual): July 15, 2026
• Last Update Submitted That Met QC Criteria: July 13, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: prenatal diagnosis; miscarriage; cell free fetal DNA; early miscarriage; prenatal test; chromosomal abnomarlities
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Abortion, Spontaneous
• Other Study ID Numbers: 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)?: YES
• 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: No
• Studies a U.S. FDA-regulated device product: No