Aneuploidy Clinical Trial
Official title:
First Trimester Risk Assessment Based on Ultrasound and Cell-free DNA vs Combined Screening: Women's Experience
There is an ongoing debate regarding how cell-free DNA (cfDNA) screening can best be
incorporated into current prenatal screening algorithms for chromosomal abnormalities.
Test performance of cfDNA has been shown to be better that first-trimester combined screening
(FTCS). However, the cost of the cfDNA testing is considered too high to adopt as first line
screening. Moreover, FTCS includes a detailed ultrasound examination of the fetus with nuchal
translucency (NT) measurement that allows for early detection of fetal abnormalities.
An approach in which every woman are offered an early anatomy scan along with cfDNA may also
be a reasonable option. Recently a randomized controlled trial, including 1,518 women with
singleton pregnancy undergoing first-trimester screening, compared the screening performance
of FTCS with an approach that uses the combination of a detailed ultrasound examination and
cfDNA analysis. The trial showed that first-trimester risk assessment for trisomy 21 that
includes a detailed ultrasound examination along cfDNA was associated with a significant
reduction in the false-positive rate compared with FTCS. This approach obviates the need for
maternal serum free beta-human chorionic gonadotropin and pregnancy-associated plasma
protein-A in screening for fetal aneuploidy.
Despite robust evidence on the very high detection rate of cfDNA in detecting trisomy 21,
literature is lacking on data regarding women's experience and emotional well-being and
satisfaction after test-results of women offered cfDNA compared to those offered FTCS.
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