Pregnancy hypertension · 2019
A randomized-controlled trial to assess the effect of ibuprofen on postpartum blood pressure in women with hypertensive disorders of pregnancy.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Triebwasser Jourdan E, Hesson Ashley, Langen Elizabeth S
Аннотация
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.
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.