A randomized-controlled trial to assess the effect of ibuprofen on postpartum blood pressure in women with hypertensive disorders of pregnancy.

OBJECTIVES

To test the hypothesis that ibuprofen is equivalent to acetaminophen in its effect on postpartum blood pressure in women with gestational hypertension or preeclampsia without severe features.

STUDY

DESIGN

Single-center randomized, crossover, equivalence trial among women with hypertensive disorders of pregnancy without severe features after vaginal delivery. Participants were assigned in a double-blind fashion to ibuprofen 600 mg or acetaminophen 650 mg every 6 h for 24 h followed by crossover to the other drug. We assessed clinical blood pressures and ambulatory blood pressure monitor measurements. Intention-to-treat analyses were performed using a linear mixed model adjusted for time period.

MAIN OUTCOME MEASURES: The mean difference in systolic blood pressure through 24 h of drug exposure with an equivalence margin of 10 mmHg.

RESULTS

Of 185 screened women, 74 enrolled prior to delivery. Forty-three women remained eligible and were randomized to ibuprofen first (n = 20, 46.5%) or acetaminophen first (n = 23, 53.5%). A total of 37 women (86.0%) received study drug (ibuprofen first n = 19, acetaminophen first n = 18). Most participants were white (91.9%) and had gestational hypertension (86.5%); mean (SD) age was 31.0 (6.5) years. The mean adjusted difference in systolic blood pressure was 1.0 mmHg (95% CI, -3.7 to 5.7 mmHg), which was within the equivalence margin. A linear mixed model did not demonstrate a main effect of group assignment, nor did it show an interaction effect with time period.

CONCLUSIONS

Among women with gestational hypertension and preeclampsia without severe features, ibuprofen is an equally safe option as acetaminophen with respect to postpartum blood pressure concerns.