Table 2.
Malaria-related perinatal outcomes by treatment group in the intention-to-treat population (all gravidities)
| ISTp-DP group | IPTp-DP group | IPTp-SP group | Crude prevalence ratio or difference (95%CI); p value | Crude prevalence ratio or difference (95%CI); p value | Crude prevalence ratio or difference (95%CI); p value | |
|---|---|---|---|---|---|---|
| ISTp-DP vs IPTp-SP | IPTp-DP vs IPTp-SP | IPTp-DP vs ISTp-DP | ||||
| Maternal haemoglobin (g/L; third trimester) | 110 (14); n=384 | 110 (14); n=370 | 111 (15); n=375 | −0.07 (−0.30 to 0.14); p=0.53 | −0.05 (−0.26 to 0.15); p=0.61 | 0.01 (−0.20 to 0.22); p=0.91 |
| Maternal anaemia (haemoglobin <110 g/L; third trimester) | 176/384 (46%) | 186/370 (50%) | 176/375 (47%) | 0.98 (0.84 to 1.14); p=0.76 | 1.07 (0.92 to 1.24); p=0.36 | 1.10 (0.95 to 1.27); p=0.22 |
| Maternal moderate anaemia (haemoglobin <90 g/L; third trimester) | 30/384 (8%) | 21/370 (6%) | 31/375 (8%) | 0.95 (0.58 to 1.53); p=0.82 | 0.69 (0.40 to 1.17); p=0.17 | 0.73 (0.42 to 1.25); p=0.25 |
| Maternal haemoglobin at delivery (g/L) | 116 (16); n=421 | 117 (15); n=426 | 116 (17); n=427 | 0.01 (−0.20 to 0.23); p=0.90 | 0.14 (−0.08 to 0.35); p=0.21 | 0.12 (−0.09 to 0.34); p=0.26 |
| Maternal anaemia at delivery (haemoglobin <110 g/L) | 142/421 (34%) | 115/426 (27%) | 147/427 (34%) | 0.98 (0.81 to 1.18); p=0.81 | 0.78 (0.64 to 0.96); p=0.0165 | 0.80 (0.65 to 0.98); p=0.0311 |
| Maternal moderate anaemia at delivery (haemoglobin <90 g/L) | 20/421 (5%) | 19/426 (4%) | 20/427 (5%) | 0.93 (0.52 to 1.68); p=0.82 | 0.87 (0.48 to 1.58); p=0.64 | 0.93 (0.50 to 1.71); p=0.81 |
| Malaria infection (third trimester) | 75/473 (16%) | 34/478 (7%) | 90/470 (19%) | 0.83 (0.63 to 1.09); p=0.18 | 0.37 (0.26 to 0.54); p<0.0001 | 0.45 (0.31 to 0.66); p<0.0001 |
| Peripheral or placental malaria at delivery (any measure including PCR, excluding past infections) | 79/452 (17%) | 26/457 (6%) | 73/459 (16%) | 1.10 (0.82 to 1.47); p=0.52 | 0.36 (0.23 to 0.55); p<0.0001 | 0.33 (0.21 to 0.50); p<0.0001 |
| Maternal peripheral malaria infection at delivery (any measure) | 65/452 (14%) | 16/457 (4%) | 54/459 (12%) | 1.22 (0.87 to 1.71); p=0.21 | 0.30 (0.17 to 0.51); p<0.0001 | 0.24 (0.14 to 0.41); p<0.0001 |
| Placental malaria (any measure including PCR and past infections on histology) | 190/414 (46%) | 139/421 (33%) | 159/426 (37%) | 1.23 (1.05 to 1.45); p=0.0121 | 0.88 (0.74 to 1.06); p=0.19 | 0.72 (0.61 to 0.85); p=0.0002 |
| Peripheral or placental malaria at delivery (any measure including PCR and past infections on histology) | 199/452 (44%) | 140/457 (31%) | 166/459 (36%) | 1.22 (1.04 to 1.43); p=0.0159 | 0.85 (0.70 to 1.02); p=0.08 | 0.70 (0.59 to 0.83); p<0.0001 |
| Maternal parasite density at delivery | 107 (45–250); n=32 | 177 (49–634); n=9 | 76 (37–154); n=29 | 0.34 (−0.73 to 1.42); p=0.53 | 0.84 (−0.76 to 2.45); p=0.30 | 0.50 (−1.08 to 2.09); p=0.54 |
| Fetal cord haemoglobin (g/L) | 141 (24); n=400 | 143 (23); n=401 | 144 (26); n=403 | −0.30 (−0.64 to 0.04); p=0.08 | −0.14 (−0.47 to 0.20); p=0.43 | 0.16 (−0.18 to 0.50); p=0.35 |
| Fetal anaemia (haemoglobin <125 g/L cord blood) | 80/400 (20%) | 81/401 (20%) | 76/403 (19%) | 1.06 (0.80 to 1.41); p=0.68 | 1.07 (0.81 to 1.42); p=0.63 | 1.01 (0.77 to 1.33); p=0.94 |
| Corrected birthweight | 3234.0 (483.8) | 3188.2 (433.0) | 3275.5 (463.2) | −41.5 (−104.4 to 21.4); p=0.19 | −87.3 (−150.1 to −24.5); p=0.0065 | −45.8 (−108.5 to 16.9); p=0.15 |
| Gestational age at birth (weeks) | 39.1 (1.8); n=451 | 39.0 (2.2); n=448 | 39.1 (1.8); n=451 | −0.08 (−0.33 to 0.17); p=0.53 | −0.11 (−0.36 to 0.14); p=0.39 | −0.03 (−0.28 to 0.22); p=0.82 |
| Birthweight for gestational age (Z score) | 0.43 (1.09); n=416 | 0.29 (0.97); n=417 | 0.51 (1.1); n=422 | −0.08 (−0.22 to 0.06); p=0.28 | −0.22 (−0.36 to −0.07); p=0.0027 | −0.14 (−0.28 to 0.003); p=0.06 |
| Small for gestational age | 36/416 (9%) | 27/417 (6%) | 25/422 (6%) | 1.46 (0.89 to 2.39); p=0.13 | 1.09 (0.65 to 1.85); p=0.74 | 0.75 (0.46 to 1.21); p=0.24 |
| Low birthweight | 19/413 (5%) | 22/414 (5%) | 18/409 (4%) | 1.05 (0.56 to 1.96); p=0.89 | 1.21 (0.66 to 2.22); p=0.54 | 1.16 (0.63 to 2.10); p= 0.64 |
| Preterm birth | 29/451 (6%) | 23/448 (5%) | 21/451 (5%) | 1.38 (0.80 to 2.38); p=0.25 | 1.10 (0.62 to 1.96); p=0.74 | 0.80 (0.47 to 1.36); p=0.41 |
| Stillbirth | 10/454 (2%) | 4/452 (1%) | 16/453 (4%) | 0.62 (0.29 to 1.36); p=0.24 | 0.25 (0.08 to 0.74); p=0.0126 | 0.40 (0.13 to 1.27); p=0.12 |
| Fetal loss* | 11/454 (2%) | 7/452 (2%) | 17/453 (4%) | 0.65 (0.31 to 1.36); p=0.25 | 0.41 (0.17 to 0.99); p=0.0463 | 0.64 (0.25 to 1.63); p=0.35 |
| Any adverse birth outcome† | 64/454 (14%) | 48/452 (11%) | 54/454 (12%) | 1.19 (0.85 to 1.66); p=0.32 | 0.89 (0.62 to 1.29); p=0.54 | 0.75 (0.53 to 1.07); p=0.11 |
| Congenital malaria infection | 5/514 (1%) | 2/504 (<1%) | 0/508 | NA | NA | NA |
| Infant clinical malaria by 6–8 weeks (cumulative) | 9/368 (2%) | 11/366 (3%) | 5/360 (1%) | 1.76 (0.59 to 5.24); p=0.31 | 2.11 (0.73 to 6.08); p=0.17 | 1.20 (0.50 to 2.90); p=0.68 |
| Neonatal death | 6/454 (1%) | 4/452 (1%) | 12/453 (3%) | 0.50 (0.19 to 1.32); p=0.16 | 0.33 (0.11 to 1.03); p=0.06 | 0.67 (0.19 to 2.36); p=0.53 |
| Perinatal death | 16/454 (4%) | 8/452 (2%) | 27/453 (6%) | 0.59 (0.32 to 1.08); p=0.09 | 0.30 (0.14 to 0.65); p=0.0022 | 0.50 (0.22 to 1.16); p=0.11 |
| Infant deaths by 6–8 weeks (end of follow-up) | 6/454 (1%) | 4/452 (1%) | 13/453 (3%) | 0.46 (0.18 to 1.20); p=0.11 | 0.31 (0.10 to 0.94); p=0.0383 | 0.67 (0.19 to 2.36); p=0.53 |
Data are mean (SD); n, n/N (%), or geometric mean (95% CI), unless otherwise specified. ISTp-DP=intermittent screening and treatment during pregnancy with dihydroartemisinin–piperaquine. IPTp-DP=intermittent preventive treatment during pregnancy with dihydroartemisinin–piperaquine. IPTp-SP=intermittent preventive treatment during pregnancy with sulfadoxine–pyrimethamine.
*
Spontaneous abortion or stillbirth.
†
Small for gestational age, low birthweight, preterm birth, or fetal loss.