Data management tools in the DOMINO trial: DHA in pregnancy to prevent postnatal depressive symptoms and enhance neurodevelopment in children

The DOMInO study is a national, multicentre, double blind trial of fish oil capsules, rich in docosohexaenoic acid (DHA), versus placebo in pregnant women from 20 weeks gestation until birth. The Edinburgh Post‐Natal Depression Scale (EPNDS) will be administered to 2200 women at 6 weeks and at 6 months post‐partum. In addition, all preterm infants and a random sample of term infants (n 750 approx) will be assessed at 18 months using the Bayley Scales of Infant Development. DOMInO is the most comprehensive study to date on the effects of fish oil supplementation on the well being of mothers and development of infants. We present the data management plan for this study and demonstrate some of the tools we have developed to support it. In particular we discuss integrated support for substudies, notification processes for subjects considered at‐risk on the basis of the EPNDS, and a sophisticated query raising and resolving tool.