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Table 2 Birth outcomes by trial arm

From: Excess risk of preterm birth with periconceptional iron supplementation in a malaria endemic area: analysis of secondary data on birth outcomes in a double blind randomized controlled safety trial in Burkina Faso

Outcomea

n

missing

Iron

Control

Relative risk/differenceb

P

Adjusted relative risk/differencec

P cadj

Infant

 Neonatal death, n/N (%)d

433

0

6/231 (2.6)

3/202 (1.5)

1.75 (0.44; 6.93)

0.41

1.70 (0.43;6.80)

0.44

 Livebirth male, n/N (%)d

409

24

106/219 (48.4)

101/190 (53.2)

0.91 (0.75; 1.10)

0.34

0.89 (0.74;1.08)

0.25

 Gestation, days ± SDe

286

21

264.0 ± 17.5 [14 missing]

269.4 ± 17.3 [7 missing]

− 5.36 (− 9.42; − 1.30)

0.010

− 5.21 (− 9.26; − 1.16)

0.012

 Preterm < 37 weeks, n/N (%)e

286

21

41/149 (27.5)

19/137 (13.9)

1.98 (1.21; 3.25)

0.004

2.24 (1.39; 3.61)

< 0.001

 Preterm < 34 weeks, n/N (%)e

286

21

14/149 (9.4)

6/137 (4.4)

2.15 (0.85; 5.45)

0.091

2.25 (0.89; 5.67)

0.069

 Post-term > 41 weeks, n/N (%)e

286

21

4/149 (2.7)

9/137 (6.6)

0.41 (0.13; 1.30)

0.11

0.41 (0.13; 1.31)

0.11

 Birthweight, g ± SDe

294

13

2640 ± 486 [8 missing]

2740 ± 420 [5 missing]

− 100 (− 205; 5)

0.062

− 111 (− 213; − 9)

0.033

 Low birthweight, n/N (%)e

294

13

54/155 (34.8)

40/139 (28.8)

1.21 (0.86; 1.70)

0.27

1.34 (0.99; 1.81)

0.062

 SGA, n/N (%)e

277

30

41/143 (28.7)

48/134 (35.8)

0.80 (0.57; 1.13)

0.20

0.82 (0.59; 1.14)

0.25

Placental pathology, n/N (%)f

 Acute malaria

181

0

5/89 (5.6)

7/92 (7.6)

0.74 (0.24; 2.26)

0.59

0.84 (0.28; 2.53)

0.76

 Chronic malaria

181

0

28/89 (31.5)

20/92 (21.7)

1.45 (0.88; 2.38)

0.14

1.30 (0.84; 1.99)

0.25

 Past malaria

181

0

44/89 (49.4)

52/92 (56.5)

0.87 (0.66; 1.16)

0.34

0.89 (0.71; 1.11)

0.29

 Chorioamnionitis, grade 3g

179

2

6/89 (6.7)

7/90 (7.8)

0.87 (0.30; 2.50)

0.79

0.87 (0.3; 2.51)

0.80

 Chorioamnionitis, grade 2 and 3

179

2

36/89 (40.4)

44/90 (48.9)

0.83 (0.59; 1.15)

0.26

0.75 (0.58–0.97)

0.050

  1. aGestational age is by ultrasound at ANC1 except one by Ballard assessment at birth; Preterm: 20–36 completed weeks, or 20 to 33 completed weeks
  2. bRelative risk for the categorical variables; difference in days or g for gestation and weight
  3. cAdjusted for MUAC at baseline, bed net use to ANC1 or last follow-up, and birth month
  4. dBased on full analysis dataset, n = 435
  5. eBased on 307 with post-delivery assessment
  6. fBased on 181 with a placental biopsy. Acute infection: only parasites and minimal hemozoin deposition in the macrophages but not fibrin
  7. Chronic infection: parasites and hemozoin deposition; Past infection: hemozoin usually mixed with fibrin but no parasites
  8. gSeverity of acute chorioamnionitis and funiculitis (acute histologic chorioamnionitis) was graded histologically as early (grade 1), intermediate (grade 2) and advanced (grade 3) following the Redline-classification [17, 18]
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Malaria Journal

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