Informed choice in antenatal Down syndrome screening: A cluster-randomised trial of combined versus separate visit testing

Objective: Building upon the results of an observational study, this clinical trial aimed to test the hypothesis that conducting antenatal Down syndrome screening (DSS) at the same time as other tests result in higher rates of informed choice to accept DSS, than when it is conducted separately from other tests. Methods: The trial used a cluster-randomised controlled design, with informed choice as the outcome measure. The post of midwife was randomised to offer DSS at the same time as other tests (combined visit) or separately from other tests (separate visit). Results: Overall 43.5% of women made an informed choice about DSS. There was no difference in rates of informed choice for women accepting DSS according to the method of conducting testing (23.7% at combined visit versus 22.5% at separate visit, OR = 1.1, 95% Cl: 0.70-1.7, p = 0.67). Conclusion: Rates of informed choice about DSS were low, but there was no evidence to support that hypothesis that conducting testing at that same time as other tests increased rates of informed choice. This may reflect the limitations of conducting the trial in one centre. (c) 2005 Elsevier Ireland Ltd. All rights reserved.