GRACE - Genetic Insights Into Early pRegnancy Loss Using Cell-free fEtal DNA

NCT07639333 | Recruiting

• 2 other identifiers: 35RC25_8835_10_GRACE2026-A00248-43
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Miscarriage in First Trimester; Prenatal Genetic Diagnosis

Keywords

early miscarriage; miscarriage; prenatal diagnosis; prenatal test; cell free fetal DNA; chromosomal abnomarlities

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Long term Psychological distress score

  12 months

• Rate of balanced chromosomal abnormalities in a parent

  8 weeks

• Number of modified care pathways

  12 months

• Number of pregnancies

  12 months

Study Arms (1)

Patient

EXPERIMENTAL

Genetic: Non invasive prenatal test

Interventions

Non invasive prenatal test GENETIC

cell free fetal DNA analysis

Patient

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

CHU Rennes

Rennes, France

RECRUITING

MeSH Terms

Conditions

Abortion, Spontaneous

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Marion Mercier, Md

  Rennes University Hospital

  STUDY DIRECTOR

• Vincent LAVOUE, Pr

  Rennes University Hospital

  STUDY CHAIR

• Sylvie JAILLARD

  Rennes University Hospital

  STUDY CHAIR

• Erika LAUNAY

  Rennes University Hospital

  STUDY CHAIR

Central Study Contacts

Marie-Laure Gervais

CONTACT

299282555; marie-laure.gervais@chu-rennes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Patient can refuse to know the result of NIPT
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 10, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data availability after the primary publication of the results and until the database is deleted
• 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.

Locations

FR (1)