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

N/ANot Yet RecruitingNCT07639333

Rennes University Hospital100 enrolled

Overview

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

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

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

100

Conditions

Miscarriage in First Trimester Prenatal Genetic Diagnosis

Interventions

Non invasive prenatal testGENETIC

cell free fetal DNA analysis

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 43 Years

Medical Language ↔ Plain English

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

Locations (1)

CHU Rennes

Rennes, France

Outcomes

Primary Outcomes

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.

Time frame: 8 weeks

Secondary Outcomes

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.

Time frame: 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

Time frame: 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

Central Contacts

Marie-Laure Gervais

CONTACT

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.