"Circulating Fetal DNA, Pregnancy And Immune Diseases"
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Autoimmune Diseases
- Pregnancy
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
Circulating fetal DNA (cfDNA) in maternal blood is now routinely used for prenatal screening for Down syndrome 21 (T21). In about 1% of cases, the test result is not contributory (NC). The investigator's team recently found, in a retrospective study, an association between the existence of an autoim...
Circulating fetal DNA (cfDNA) in maternal blood is now routinely used for prenatal screening for Down syndrome 21 (T21). In about 1% of cases, the test result is not contributory (NC). The investigator's team recently found, in a retrospective study, an association between the existence of an autoimmune disease (AID) and a high risk of NC. However, this was only a subgroup analysis, requiring confirmation by a dedicated study. Tests using deoxyribonucleic Care (dNCare) are becoming more widespread, so it is important to prospectively evaluate the results of these tests in the population of patients with AID, which represents about 3 to 5% of pregnant women. The main objective of this study is to compare the rate of NC in a population of patients with DIA to that of a population of patients without MAI when screened for T21 by the cfDNA study in the first trimester of pregnancy. The secondary objectives are : To assess the performance of fetal cfDNA for T21 screening in the population of PATIENTS with AID and to compare them with performance in the non-auto immune disease population. To assess the performance of the combined first trimester screening for T21 screening and compare it with those of fetal cfDNA in the population of patients with AID. In patients with an NC result, analysis of the distribution of fetal fractions according to the presence and severity of maternal autoimmune pathologies. The distribution will be compared to that of the control population. To assess the association between fetal fraction and the occurrence of vascular complications of pregnancy in both groups with and without auto immune disease. AFFEPI is a prospective multicenter, interventional, exposed/non-exposed cohort study There are two group : Exposed group: Any patient with a auto immune disease followed at one of the 14 centres who wants to be screened for T21. Unexposed group: Patients who do not carry an auto immune disease identified at the interview (no history of auto immune disease; no symptoms suggestive of a auto immune disease).
Tracking Information
- NCT #
- NCT04155086
- Collaborators
- CERBA laboratory
- Investigators
- Not Provided