Background Pregnant SLE women are at high risk of pre-eclampsia. Aspirin reduces its risk but is used only in a minority of SLE pregnancies. This randomized controlled trial evaluated a specifically-designed educational tool on pre-eclampsia knowledge, aspirin use and adherence in SLE pregnancies. We present interim results.
Methods We recruited pregnant SLE women up to 16 gestational weeks at 5 Canadian SLICC centres. Participants were randomly assigned to the educational tool (intervention) or standard of care (control). At every pregnancy visit, participants completed pre-eclampsia questionnaire, aspirin survey, and modified Adherence to Refills and Medications Scale (ARMS). We performed Student’s t-test and univariate linear regression to assess pre-eclampsia knowledge, and estimated 95% CI for difference in proportion of aspirin users using the Wilson procedure. We evaluated mean ARMS score difference with Student’s t-test and Mann-Whitney U test.
Results Thirty-eight women were included, with 20 exposed to the intervention. Baseline characteristics were well-balanced. The difference in mean pre-eclampsia knowledge scores between 1st and 2nd trimester visits in the intervention group was 5.0 points (95% CI 1.4, 8.6) and 1.1 points (95% CI -3.1, 5.4) in the control group when all women were included regardless of fetal loss. The mean difference in scores for those receiving the educational tool was 4.1 points higher (95% CI 0.4, 7.9) than those receiving standard of care. There was a trend of higher aspirin use in the intervention group. Aspirin adherence was high regardless of intervention status.
Conclusions Midway into the trial, pre-eclampsia knowledge improved from 1st to 2nd trimester visits in pregnant SLE women who received the tool compared to those who did not. There was a trend of higher aspirin use in women receiving the educational tool. The trial is well-poised to provide a new evidence-based approach to improve pre-eclampsia knowledge and potentially optimize aspirin use and pregnancy outcomes.
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