TABLE 2.
Unexpected medical visit and potential side effects: Aspirin Supplementation for Pregnancy Indicated Risk Reduction In Nulliparas trial
| Variable | Total (N=11,879) | Aspirin (n=5943) | Placebo (n=5936) | RR (95% CI) | P value |
|---|---|---|---|---|---|
| Unexpected emergency medical visit | |||||
| At least 1 unexpected emergency medical visit | 3989 (33.6) | 2015 (33.9) | 1974 (33.3) | 1.02 (0.98–1.06) | .247 |
| Number of unexpected medical visits | 1 (1–2) | 1 (1–2) | 1 (1–2) | 0.97 (0.93–1.02) | .223 |
| Biweekly monitoring of potential side effects | |||||
| Any potential side effect | |||||
| At least 1 episode | 5857 (49.3) | 2947 (49.6) | 2910 (49.0) | 1.00 (0.98–1.03) | .804 |
| Number of potential side effects, median | 3 (1–7) | 3 (1–7) | 3 (1–6) | 0.98 (0.95–1.00) | .040 |
| Nausea | |||||
| At least 1 episode | 3402 (28.6) | 1691 (28.5) | 1711 (28.8) | 0.98 (0.94–1.03) | .505 |
| Number of episodes | 2 (1–3) | 2 (1–3) | 2 (1–3) | 1.01 (0.97–1.05) | .679 |
| Vomiting | |||||
| At least 1 episode | 3198 (26.9) | 1587 (26.7) | 1611 (27.1) | 0.99 (0.94–1.04) | .641 |
| Number of episodes | 2 (1–3) | 2 (1–3) | 2 (1–3) | 0.99 (0.95–1.04) | .677 |
| Rash or hives | |||||
| At least 1 episode | 458 (3.9) | 251 (4.2)a | 207 (3.5)a | 1.20 (1.01–1.43)a | .042a |
| Number of episodes | 1 (1–2) | 1 (1–2) | 1 (1–2) | 0.97 (0.83–1.13) | .674 |
| Diarrhea | |||||
| At least 1 episode | 877 (7.4) | 452 (7.6) | 425 (7.2) | 1.06 (0.94–1.20) | .342 |
| Number of episodes | 1 (1–1) | 1 (1–1) | 1 (1–1) | 0.94 (0.83–1.05) | .279 |
| Gastritis | |||||
| At least 1 episode | 1752 (14.7) | 853 (14.4) | 899 (15.1) | 0.94 (0.87–1.02) | .149 |
| Number of episodes | 1 (1–2) | 1 (1–2) | 1 (1–2) | 0.97 (0.91–1.04) | .406 |
| Vaginal bleeding | |||||
| At least 1 episode | 457 (3.8) | 214 (3.6) | 243 (4.1) | 0.88 (0.73–1.05) | .150 |
| Number of episodes | 1 (1–1) | 1 (1–1) | 1 (1–1) | 1.03 (0.86–1.22) | .778 |
| Allergic reaction | |||||
| At least 1 episode | 45 (0.4) | 22 (0.4) | 23 (0.4) | 0.96 (0.53–1.71) | .882 |
| Number of episodes | 1 (1–1) | 1 (1–1) | 1 (1–1) | 0.99 (0.57–1.73) | .982 |
| Other potential side effect | |||||
| At least 1 episode | 3313 (27.9) | 1673 (28.2) | 1640 (27.6) | 1.01 (0.97–1.06) | .611 |
| Number of episodes | 2 (1–3) | 2 (1–3) | 2 (1–3) | 0.99 (0.95–1.04) | .696 |
Data are presented as number (percentage) or median (25th percentile–75th percentile). Unexpected emergency medical visits may have been related to potential side effects but are analyzed separately from potential side effects reported at biweekly visits. For “at least 1” variables, the denominator is any participant included in the safety population, and the numerator is participants with at least 1 report of the event. For “number of” variables, the denominator is any participant included in the safety population who experienced at least 1 episode of that specific event, and the numerator is the number of events of that specific type experienced by the participant. In addition, the “number of” RR models have been adjusted for the number of biweekly visits completed (range, 1–16). The most commonly reported other potential side effects include cold/cough or fever, abdominal pain or discomfort, and headache.
CI, confidence interval; RR, relative risk.
P<.05.
Short. Aspirin safety during pregnancy in low- and middle-income countries. Am J Obstet Gynecol Glob Rep 2021.