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First Trimester Screening for Trisomy 21, 18, 13 and 22q11.2 Deletion Syndrome — ReFaPo02  

Pregnancy Clinical Trial

Official title:
First Trimester Screening for Trisomy 21, 18, 13 and 22q11.2 Deletion Syndrome - ReFaPo02

Clinical Trial Summary

Combined first-trimester screening represents the gold standard of risk assessment for the presence of trisomy 21, 18, and 13. The concept is based on the age risk, the measurement of fetal nuchal translucency (NT), and the determination of serum markers free beta-hCG and PAPP-A in maternal blood. In recent years it has been shown that the risk assessment can be improved by combining in-depth ultrasound and cell-free DNA analysis from maternal blood. In their latest study, the investigators were able to detect all fetuses with trisomy 21, 18, and 13 through this procedure. No normal fetus displayed an increased risk. In contrast, the detection rate in classic, combined first-trimester screening is about 95% and the false-positive rate is 3-5%. In this study the investigator examine the test quality - especially the false positives - of cell-free DNA analysis on trisomy 21, 18 and 13 as well as on the microdeletion 22q in 1000 pregnancies.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03375359
Study type Observational
Source University Hospital Tuebingen
Contact Karl-Oliver Kagan, Prof.
Phone +49 7071 29-82211
Email karl.kagan@med.uni-tuebingen.de
Status Recruiting
Phase
Start date January 8, 2018
Completion date August 31, 2022
View Details
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