ABSTRACT
OBJECTIVES: We designed a computer-based decision aid (CDA) for use by pregnant women at home to investigate and participate in solving their pregnancy problems related to pregnancy-induced hypertension (PIH) and gestational diabetes (GD). The system cannot and is not intended to replace visits to physicians; rather it can help women focus on the most important symptoms and provides guidance on when to see a doctor. METHODS: The study is a randomized controlled trial, which is performed among Iranian pregnant women. For subjects, 420 healthy pregnant women have been recruited from two private and two public prenatal centers. The intervention group will receive the CDA for use at home, and the control group will receive care as usual. The CDA relies on knowledge extracted from the national guidelines on PIH and GD. RESULTS: The two primary outcomes for the study are self-efficacy and knowledge. Self-efficacy will be measured by the Stanford self-efficacy scale and knowledge will be evaluated by 15 binary (true/false) questions provided by the researchers. Secondary outcomes include type and frequency of doctor and/or medical center visits; blood pressure and blood sugar changes based on the national guidelines and according to pregnancy records, and anxiety will be assessed by the state component of the short Spielberger anxiety scale. CONCLUSIONS: This paper describes the design of a CDA and a protocol for a randomized controlled trial to study the effects of the CDA on self-efficacy and knowledge of pregnant women pertaining to PIH and GD. Differences in the primary outcomes will be analyzed using 'intention-to-treat' principles.