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

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)