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Table 2 Primary and secondary efficacy outcomes based on infection with malaria in early pregnancy

From: The efficacy of low-dose aspirin in pregnancy among women in malaria-endemic countries

Variable Overall Malaria Negative Malaria Positive Aspirin – Malaria Interaction p-value
n/N (%) PR (95% CI) n/N (%) PR (95% CI) n/N (%) PR (95% CI)
Primary Outcome
 Preterm delivery
  Aspirin 83/724 (11) 0·92 (0·70, 1·22) 38/445 (9) 0·89 (0·59, 1·36) 45/279 (16) 0·95 (0·66, 1·38) 0.75
  Placebo 90/722 (12)   42/439 (10)   48/283 (17)   
Hypertensive disorders
 Aspirin 10/724 (1) 1·11 (0·45, 2·71) 8/445 (2) 0·88 (0·34, 2·25) 2/279 (1) 5·07 (0·24, 105·17)
 Placebo 9/722 (1)   9/439 (2)   0/283 (0)   
Small for gestational age
 Aspirin 89/686 (13) 1·11 (0·84, 1·48) 58/421 (14) 1·21 (0·84, 1·73) 31/265 (12) 0·97 (0·61, 1·54) 0.62
 Placebo 78/668 (12)   46/403 (11)   32/265 (12)   
Perinatal mortality
 Aspirin 41/724 (6) 0·95 (0·63, 1·44) 16/445 (4) 0·56 (0·31, 1·03) 25/279 (9) 1·69 (0·91, 3·14) 0.014
 Placebo 43/722 (6)   28/439 (6)   15/283 (5)   
Other Maternal Outcomes of Interest
 Vaginal bleeding
  Aspirin 12/713 (2) 0·86 (0·40, 1·85) 11/437 (3) 0·91 (0·41, 2·05) 1/276 (0) 0·51 (0·05, 5·56) 0.64
  Placebo 14/715 (2)   12/435 (3)   2/280 (1)   
Antepartum hemorrhage
 Aspirin 4/721 (1) 8·95 (0·48, 165·94) 4/442 (1) 8·86 (0·48, 164·04) 0/279 (0) 1·01 (0·02, 50·76)
 Placebo 0/717 (0)   0/435 (0)   0/282 (0)   
Postpartum hemorrhage
 Aspirin 6/724 (1) 2·99 (0·61, 14·77) 2/445 (0) 4·93 (0·24, 102·46) 4/279 (1) 2·03 (0·37, 10·99)
 Placebo 2/722 (0)   0/439 (0)   2/283 (0)   
Maternal mortality through 42 days
 Aspirin 0/724 (0) 0·33 (0·02, 8·15) 0/445 (0) 0·33 (0·02, 8·05) 0/279 (0) 1·01 (0·02, 50·94)
 Placebo 1/722 (0)   1/439 (0)   0/283 (0)   
Preterm and hypertensive disorders
Aspirin 1/724 (0) 2·99 (0·12, 73·32) 0/445 (0) 0·99 (0·02, 49·61) 1/279 (0) 3·04 (0·12, 74·38)
Placebo 0/722 (0)   0/439 (0)   0/283 (0)   
Other Fetal Outcomes of Interest
 Preterm < 34 weeks of pregnancy
  Aspirin 30/724 (4) 0·88 (0·54, 1·42) 15/445 (3) 0·74 (0·38, 1·43) 15/279 (5) 1·09 (0·53, 2·21) 0.40
  Placebo 34/722 (5)   20/439 (5)   14/283 (5)   
Birth weight < 2500 g
 Aspirin 76/715(11) 0·94 (0·70, 1·27) 37/439 (8) 0·91 (0·59, 1·39) 39/276 (14) 0·98 (0·65, 1·47) 0.69
 Placebo 80/708 (11)   40/432 (9)   40/276 (15)   
Birth weight < 1500 g
 Aspirin 9/715 (1) 0·69 (0·29, 1·59) 1/439 (0) 0·10 (0·01, 0·77) 8/276 (3) 2·67 (0·71, 9·95) 0.007
 Placebo 13/708 (2)   10/432 (2)   3/276 (1)   
Stillbirth
 Aspirin 14/718 (2) 0·87 (0·43, 1·76) 8/442 (2) 0·87 (0·34, 2·23) 6/276 (2) 0·87 (0·30, 2·55) 0.99
 Placebo 16/712 (2)   9/432 (2)   7/280 (3)   
Malaria in late pregnancy (26–30 weeks)
 Aspirin 92/296 (31) 1·13 (0·88, 1·45) 42/177 (24) 1·42 (0·93, 2·15) 50/119 (42) 0·94 (0·70, 1·26) 0.15
 Placebo 83/301 (28)   31/185 (17)   52/116 (45)