Table 3.
Per Protocol analysis of pregnancy outcomes for women randomized in the trial using Poisson regression analysis with robust error estimation (crude and adjusted incident rate ratios)
| Prevalence (Proportion) of women with characteristics | Crude IRR (95% CI) |
Adjusted IRR* (95% CI) |
||
|---|---|---|---|---|
| Characteristics | 2-dose SP | 3-dose SP | ||
| Overall | ||||
| LBW | 11.9 (28/235) | 9.6 (13/136) | 0.80 (0.42 - 1.49) | 0.84 (0.45 - 1.54) |
| Anaemia | 46.1 (119/258) | 50.7 (75/148) | 1.09 (0.89 - 1.35) | 1.12 (0.91 - 1.38) |
| Severe anaemia | 2.3 (6/258) | 1.4 (2/148) | 0.58 (0.12 - 2.84) | 0.63 (0.12 - 3.46) |
| Premature delivery (%) | 11.3 (29/257) | 9.5 (14/148) | 0.83 (0.46 - 1.53) | 0.77 (0.43 - 1.35) |
| Spontaneous abortion (%) | 1.2 (3/257) | 2.0 (3/148) | 1.73 (0.35 - 8.51) | 1.56 (0.34 - 7.10) |
| Stillbirth | 1.2 (3/257) | 2.7 (4/148) | 2.31 (0.5 - 10.22) | 2.32 (0.47 - 11.36) |
| Neonatal death | 1.3 (2/136) | 1.5 (2/136) | 1.15 (0.19 - 6.82) | 1.29 (0.21 - 7.99) |
| Gravidae 1 | ||||
| LBW | 19.2 (9/47) | 13.6 (3/22) | 0.71 (0.21 - 2.39) | 0.78 (0.22 - 2.72) |
| Anaemia | 63.5 (33/52) | 58.3 (14/24) | 0.92 (0.62 - 1.36) | 1.00 (0.68 - 1.49) |
| Severe anaemia | 3.9 (2/52) | 0 | - | - |
| Premature delivery (%) | 17.3 (9/52) | 12.5 (3/24) | 0.72 (0.21 - 2.45) | 0.56 (0.15 - 2.09) |
| Spontaneous abortion (%) | 3.9 (2/52) | 4.2 (1/24) | 1.08 (0.10 - 11.52) | 0.31 (0.08 - 1.25) |
| Stillbirth | 1.9 (1/52) | 0 | - | - |
| Neonatal death | 4.3 (2/47) | 0 | - | - |
| Gravidae 2-3 | ||||
| LBW | 15.4 (12/78) | 11.5 (6/52) | 0.75 (0.29 -1.87) | 0.81 (0.32 - 2.01) |
| Anaemia | 41.7 (35/84) | 43.9 (25/57) | 1.05 (0.71 - 1.55) | 1.10 (0.73 - 1.66) |
| Severe anaemia | 2.4 (2/84) | 1.8 (1/57) | 0.89 (0.06 - 8.00) | 0.92 (0.10 - 8.77) |
| Premature delivery (%) | 15.5 (13/84) | 12.3 (7/57) | 0.79 (0.34 - 1.87) | 0.77 (0.35 - 1.68) |
| Spontaneous abortion (%) | 0 | 1.8 (1/57) | - | - |
| Stillbirth | 0 | 5.3 (3/57) | - | - |
| Neonatal death | 0 | 0.8 (1/130) | - | - |
| Gravidae ≥4 | ||||
| LBW | 6.4 (7/110) | 6.5 (4/62) | 1.01 (0.31 - 3.34) | 1.09 (0.32 - 3.68) |
| Anaemia | 41.8 (51/122) | 53.7 (36/67) | 1.28 (0.95 - 1.75) | 1.26 (0.92 - 1.71) |
| Severe anaemia | 1.6 (2/122) | 1.5 (1/67) | 0.91 (0.08 - 9.91) | - |
| Premature delivery (%) | 5.8 (7/121) | 5.9 (4/67) | 0.72 (0.21 - 2.45) | - |
| Spontaneous abortion (%) | 0.8 (1/121) | 1.5 (1/67) | - | - |
| Stillbirth | 1.6 (2/121) | 1.5 (1/67) | 0.90 (0.08 - 9.83) | 0.77 (0.04 - 15.87) |
| Neonatal death | 0.9 (1/110) | 1.6 (1/62) | 1.77 (0.11 - 2.80) | - |
*Adjusted for age category, BMI, malaria infection, malaria season at delivery, supplementation and parity category (the later in the overall analysis only)