Table 3.
Clinical outcomes
| No (%)* | Absolute risk reduction (95%CI); relative risk (95% CI)* | ||||||
|---|---|---|---|---|---|---|---|
| Placebo (n=222) | L-arginine + vitamins (n=228) | Vitamins alone (n= 222) | L-arginine + vitamins v placebo | Vitamins alone v placebo | L-arginine + vitamins v vitamins alone | ||
| Primary outcome | |||||||
| Pre-eclampsia or eclampsia | 67 (30) | 29 (13) | 50 (23) | 0.17 (0.12 to 0.21); 0.42 (0.28 to 0.62) (χ2: P<0.001) | 0.07 (0.005 to 0.15); 0.74 (0.54 to 1.02) (χ2: P= 0.052) | 0.09 (0.05 to 0.14); 0.56 (0.37 to 0.85) (χ2: P=0.004) | |
| Secondary outcomes | |||||||
| Total preterm delivery | 44 (20) | 24 (11) | 52 (23) | 0.09 (0.05 to 0.13); 0.53 (0.33 to 0.84) (χ2: P=0.003) | 0.03 (−0.02 to 0.09); 1.18 (0.82 to 1.68) (χ2: P=0.419) | 0.12 (−0.08 to 0.17); 0.44 (0.28 to 0.70) (χ2: P<0.001) | |
| Spontaneous preterm delivery | 13 (6) | 12 (5) | 15 (7) | 0.005 (−0.03 to 0.02); 0.89 (0.41 to 1.92) (χ2: P=0.631) | 0.009 (−0.02 to 0.04); 1.15 (0.56 to 2.36) (χ2: P=0.845) | 0.01 (−0.04 to 0.14); 0.77 (0.37 to 1.62) (χ2: P=0.386) | |
| Caesarean section | 152 (68.4) | 155 (67.9) | 148 (66.6) | −0.004 (−0.67 to 0.57); 0.99 (0.87 to 1.12) (χ2: P=0.832) | −0.01 (−0.08 to 0.04); 0.97 (0.85 to 1.10) (χ2: P= 0.612) | 0.01 (−0.04 to 0.75); 1.01 (0.89 to 1.15) (χ2: P=0.843) | |
| Mean (SD) gestational age at delivery | 38.4 (2.2) | 39.0 (1.9) | 38.6 (1.9) | 0.65 (0.27 to 1.04)† (P=0.001) | 0.29 (−0.68 to 0.09)† (P=0.13) | 0.35 (−0.7 to 0.004)† (P=0.051) | |
| Sex of baby (F/M) | 115/107 | 117/111 | 110/112 | χ2: P=0.993 | χ2: P=0.704 | χ2: P=0.780 | |
| Mean (SD) Apgar score: | |||||||
| 1 minute | 7.8 (1.1) | 8.2 (0.8) | 8.0 (0.8) | 0.44 (0.24 to 0.64)† (P=0.000) | 0.25 (0.04 to 0.47)† (P=0.015) | 0.18 (0.01 to 0.36)† (P=0.04) | |
| 5 minutes | 8.7 (0.7) | 8.9 (0.3) | 8.9 (0.3) | 0.21 (0.10 to 0.33)† (P=0.000) | 0.16 (0.05 to 0.46)† (P=0.007) | 0.05 (0.02 to 0.12)† (P=0.18) | |
| Mean (SD) neonatal weight (g) | 3070.2 (470) | 2988.6 (506) | 2990.7 (451) | 81, (−15 to 179)† (P=0.1) | 2 (−102 to 98)† (P=0.96) | 79 (−17 to 175)† (P=0.1) | |
| Mean (SD) neonatal length (cm) | 48.5 (3.0) | 47.9 (3.5) | 47.8 (2.9) | 0.6 (−1.2 to 0.1)† (P=0.10) | 0.1 (−0.6 to 0.8)† (P=0.78) | 0.7 (0.03 to 1.3)† (P=0.04) | |
*Unless stated otherwise.
†Mean difference (95% CI).