TABLE 3.
Secondary outcomes
| Outcome | Time point | 500 mg | 1000 mg | Estimate (95% CI) | P‐value |
|---|---|---|---|---|---|
|
Rate of repeat infusions, a mean (SD) (n) |
n = 152 | n = 126 | |||
| Prior to delivery | 0.37 (0.51) (n = 76) | 0.14 (0.35) (n = 77) | 2.58 (1.38–4.82) | 0.003 | |
| After delivery | 0.64 (0.72) (n = 140) | 0.31 (0.57) (n = 111) | 2.10 (1.42–3.10) | <0.001 | |
| Overall | 0.81 (0.84) (n = 140) | 0.40 (0.69) (n = 111) | 2.05 (1.45–2.91) | <0.001 | |
|
Iron status, mean (SD) (n) | |||||
| Ferritin b microg/L (half threshold method) | 4 weeks | 57 (49) (n = 69) | 147 (100) (n = 65) | −90.1 (−115.1 to −65.1) | <0.001 |
| 6 weeks PP | 68 (61) (n = 115) | 115 (76) (n = 82) | −53.0 (−71.8 to −34.3) | 0.004 | |
| 3 months PP | 75 (50) (n = 97) | 96 (66) (n = 64) | −25.7 (−43.0 to −8.5) | <0.001 | |
| 6 months PP | 58 (30) (n = 85) | 85 (64) (n = 61) | −28.6 (−42.1 to −15.2) | <0.001 | |
| 12 months PP | 58 (52) (n = 88) | 69 (59) (n = 66) | −8.5 (−24.8 to 7.8) | 0.31 | |
| Transferrin saturation, b % | 4 weeks | 13 (6) (n = 67) | 20 (8) (n = 62) | −6.4 (−8.7 to −4.1) | <0.001 |
| 6 weeks PP | 20 (10) (n = 114) | 22 (9) (n = 81) | −1.2 (−4.0 to 1.6) | 0.40 | |
| 3 months PP | 22 (10) (n = 96) | 23 (9) (n = 64) | −1.3 (−4.0 to 1.4) | 0.34 | |
| 6 months PP | 20 (9) (n = 84) | 21 (9) (n = 58) | 0.1 (−3.1 to 3.2) | 0.96 | |
| 12 months PP | 20.98 (9.06) (n = 86) | 19.72 (9.64) (n = 64) | 1.78 (−1.36 to 4.93) | 0.27 | |
|
Antenatal and delivery, n/N (%) | |||||
| Gestational diabetes c | 23/150 (15%) | 27/121 (22%) | 0.61 (0.32–1.13) | 0.12 | |
| Pre‐eclampsia c | 4/150 (3%) | 9/122 (7%) | 0.33 (0.10–1.10) | 0.07 | |
| Preterm delivery c | 5/151 (3%) | 7/126 (6%) | 0.56 (0.17–1.82) | 0.34 | |
| Antepartum haemorrhage d | 5/150 (3%) | 9/121 (7%) | 0.43 (0.14–1.32) | 0.14 | |
| Postpartum haemorrhage (EBL >500 ml) c | 41/150 (27%) | 37/124 (30%) | 0.87 (0.51–1.48) | 0.61 | |
| PPROM | 0/150 (0%) | 6/121 (5%) | — | 0.007 e | |
| Mode of delivery e | |||||
| Normal vaginal, reference | 85/151 (56%) | 76/126 (60%) | 1.00 | ||
| Instrumental vaginal | 16/151 (11%) | 9/126 (7%) | 1.62 (0.67–3.88) | 0.28 | |
| Emergency caesarean section | 18/151 (12%) | 13/126 (10%) | 1.23 (0.57–2.69) | 0.60 | |
| Elective caesarean Section | 32/151 (21%) | 28/126 (22%) | 0.98 (0.54–1.79) | 0.95 | |
|
Neonatal outcomes, f mean (SD) | |||||
| Gestational age at delivery, days | 275 (10) (n = 151) | 275 (9) (n = 126) | 0.28 (−1.93 to 2.50) | 0.80 | |
| Birthweight, g | 3513 (532) (n = 151) | 3522 (468) (n = 126) | −28.6 (−187.2 to 130.0) | 0.72 | |
| Birthweight centile | 51 (30) (n = 151) | 52 (29) (n = 126) | −1.78 (−8.91 to 5.35) | 0.63 | |
| Birth length, cm | 50 (2) (n = 151) | 50 (2) (n = 124) | −0.17 (−1.52 to 1.17) | 0.80 | |
| Head circumference, cm | 35 (2) (n = 151) | 35 (2) (n = 126) | −0.30 (−1.25 to 0.64) | 0.53 | |
|
Child neurodevelopment, f mean (SD) (n) |
12 months | ||||
| Communication | 49 (11) (n = 77) | 51 (10) (n = 53) | −1.36 (−5.03 to 2.32) | 0.47 | |
| Gross motor | 45 (16) (n = 75) | 46 (17.3) (n = 53) | −1.67 (−7.56 to 4.21) | 0.58 | |
| Fine motor | 50 (10) (n = 77) | 51 (11) (n = 53) | −0.44 (−4.18 to 3.30) | 0.82 | |
| Problem solving | 43 (14) (n = 76) | 47 (13) (n = 53) | −3.67 (−8.31 to 0.97) | 0.12 | |
Abbreviations: MD, mean difference; OR, odds ratio; RM, repeated measures; RR, rate ratio.
RM Poisson regression: estimate is RR for 500/1000 mg adjusted for stratification.
RM linear mixed models: estimate is MD for 500–1000 mg adjusted for baseline and stratification.
Logistic regression: estimate is OR for outcome for 500/1000 mg adjusted for stratification.
Fisher's exact test.
Multinomial logistic regression: estimate is OR for category versus reference for 500/1000 mg adjusted for stratification.
Linear regression: estimate is MD for 500–1000 mg adjusted for stratification.