18.05.16 Prenatal trials and projects

Question 1

What were the objectives of the EACH study?

Answer 1

Three year project (Oct ‘11 - Sept ‘14) funded by the Efficacy and Mechanism Evaluation Programme

1) To test whether array CGH should replace karyotyping in prenatal diagnosis of foetal anomalies detected by routien ultrasound screening
2) To evaluate whether NIPD can reliably be used to replace conventional invasive testing for the diagnosis of Down syndrome and other major trisomies

Recruit 1500 trios from 11 FMUs in England and Wales

Question 2

What was the recruitment criteria for the EACH study?

Answer 2

Clinical indications:

one or more structural anomalies identified at the 11-14 or 18-21 week scan

or

Isolated elevated NT >3.5mm identified at the 11-14 week scan

Question 3

Describe the EACH study design.

Answer 3

Women undergoing invasive testing who meet the referral criteria consent to additional material being used for the study.

Consent for cell free foetal DNA to be extracted from maternal serum for Down syndrome NIPD