GRACE - Genetic Insights Into Early pRegnancy Loss Using Cell-free fEtal DNA
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-43
SponsorRennes University Hospital
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Non invasive prenatal test
Geneticcell free fetal DNA analysis
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: PatientExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
8 weeksSecondary outcomes
1
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 months2
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 weeks3
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
Time frame
12 months4
Number of pregnancies
Number of pregnancies and scalability during the year, according to care pathways and NIPT results
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov