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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]