449: Randomized-controlled trial of ibuprofen on post-partum blood pressure in women with hypertensive disorders of pregnancy

Abstract

To assess the effect of ibuprofen compared to acetaminophen on post-partum blood pressure in women with gestational hypertension (gHTN) or preeclampsia without severe features (preE). Single center, randomized, double-blind crossover trial among women with gHTN or preE who delivered vaginally. Participants were assigned to encapsulated tablets of ibuprofen 600 mg or acetaminophen 650 mg every 6 hours for 24 hours followed by cross-over to the other agent. Group 1 received ibuprofen first and group 2 received acetaminophen first. Blood pressures were measured per clinical protocol with additional measures from an ambulatory blood pressure monitor (Spacelabs model 90207) that measured every 60 minutes while worn. Primary outcome was the difference in systolic blood pressure from baseline over 24 hours of drug exposure. The baseline was defined as the first 5 blood pressures on admission. A linear mixed model with Gaussian subject-specific intercept term was used to regress the blood pressures on time and the interaction of group and time. Analyses were performed according to intention-to-treat principles. We screened 185 women, of whom 74 enrolled. After further exclusion for severe features or cesarean delivery, 37 women were randomized and received at least 1 dose of study drug (n=19 in group 1, n=18 in group 2). Twenty- seven women crossed-over to study drug 2 (n=17 in group 1, n=10 in group 2). The difference in systolic blood pressure per 24-hour period compared to baseline was -0.62 mm Hg (95% CI -1.77, 0.54) among women in group 1 and -0.51 mm Hg (95% CI -1.85, 0.82) among women in group 2 with no difference in rate of change between groups (p=0.91). When limited to women who crossed-over, results were similar: -0.46 mmHg (95% CI -1.71, 0.79) in group 1 vs. -0.49 mmHg (95% CI -2.13, 1.15) in group 2. The difference in diastolic blood pressure compared to baseline was -1.49 mm Hg (95% CI -2.65, -0.33) in group 1 vs. -1.21 mmHg (95% CI -2.72, 0.30) in group 2 with no difference in rate of change between groups (p=0.76). Five women in each group had at least 1 severe range blood pressure (26.3 vs. 27.8%, p=1.0). Ibuprofen did not worsen postpartum blood pressure when compared with acetaminophen among women with gHTN or preE without severe features.View Large Image Figure ViewerDownload Hi-res image Download (PPT)