Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07639333

GRACE - Genetic Insights Into Early pRegnancy Loss 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

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–43 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU Rennes

Rennes, France

Location status: Recruiting

Location contact

Marion Mercier

CONTACT

[email protected]

299284321 ext. +33

Marion Mercier, Md

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non invasive prenatal test

Genetic

cell free fetal DNA analysis

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. Number of pregnancies

    Time frame: 12 months

    Number of pregnancies and scalability during the year, according to care pathways and NIPT results

Study contacts

Contact information is provided by the study sponsor or research team.

Marie-Laure Gervais

CONTACT

[email protected]

299282555 ext. +33

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

GRACE - Genetic Insights Into Early pRegnancy Loss: A Prospective Study Using Cell-free fEtal DNA

Acronym: GRACE

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jun 10, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.