Objective: To evaluate the effect of an educational tool on preeclampsia knowledge, as well as aspirin (ASA) use and adherence in pregnant SLE women.
Methods: A two-arm parallel randomized controlled trial was conducted recruiting pregnant SLE women up to 17 weeks' gestation. Participants were randomly assigned to receive either usual-care alone or usual-care plus the tool (laminated card incorporating infographics on preeclampsia in SLE and ASA for prevention). The primary outcome was difference in preeclampsia knowledge scores at the second-trimester visit.
Results: Of 73 women included, 38 were randomized to the intervention. In the primary analysis of ongoing pregnancies, increase in the mean preeclampsia knowledge scores was 4.0 points (95% CI: 2.4, 5.6) in the intervention group and 2.0 points (95% CI: 0.3, 3.9) in controls, with a mean difference of 1.8 points higher (95% CI: -0.5, 4.2) favouring the intervention. Including end-of-pregnancy scores of women with fetal loss (six in each group), the difference was 4.8 points (95% CI: 3.3, 6.9) in the intervention group and 1.9 points (95% CI: 0.3, 3.6) in controls, with a mean increase of 2.5 points (95% CI: 0.3, 4.8) more for the intervention. Using electronic pharmacy data, there was a trend for higher ASA adherence in the intervention group (81%) vs controls (65%; difference 15%, 95% CI: -9, 37%).
Conclusion: Women with SLE who received an educational tool had greater improvement in preeclampsia knowledge vs controls. This tool may improve ASA use in SLE pregnancies and help optimize outcomes.
Trial registration: ClinicalTrials.gov, http://clinicaltrials.gov, NCT03749044.
Keywords: adherence; aspirin; clinical trial; educational tool; knowledge; preeclampsia; pregnancy; systemic lupus erythematosus.
© The Author(s) 2025. Published by Oxford University Press on behalf of the British Society for Rheumatology.