Table 5.
Prespecified comparisons of primary and secondary outcomes at birth
| Outcomes | Group A (n=1290) | Group B (n=1276) | Group C (n=1093) | Group D (n=1093) | Preconception intervention v no preconception intervention (A+B v C+D) | Pregnancy intervention v no pregnancy intervention (A+C v B+D) | Preconception and pregnancy intervention v no preconception and pregnancy intervention (A v D) | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| IRR (98.3% CI) | ARR¶ (%) or mean difference (98.3% CI) | IRR (98.3% CI) | ARR¶ (%) or mean difference (98.3% CI) | IRR (98.3% CI) | ARR¶ (%) or MD (98.3% CI) | |||||||
| Primary | ||||||||||||
| LBW*† | 267/1141 (23.4) | 239/1094 (21.9) | 235/955 (24.6) | 267/934 (28.6) | 0.85 (0.75 to 0.97) | −3.80 (−6.99 to −0.60) | 0.87 (0.76 to 1.01) | −1.71 (−4.96 to 1.54) | 0.76 (0.62 to 0.91) | −5.59 (−10.32 to −0.85) | ||
| Preterm† | 171/1283 (13.3) | 158/1259 (12.6) | 110/1080 (10.2) | 160/1081 (14.8) | 1.05 (0.87 to 1.27) | 0.59 (−1.79 to 2.98) | 0.85 (0.69 to 1.05) | −1.47 (−3.86 to 0.93) | 0.91 (0.69 to 1.19) | −0.86 (−4.36 to 2.64) | ||
| SGA† | 318/1138 (27.9) | 325/1088 (29.9) | 271/945 (28.7) | 344/925 (37.2) | 0.87 (0.78 to 0.98) | −4.04 (−7.47 to −0.62) | 0.8 (0.71 to 0.90) | −6.60 (−10.15 to −3.05) | 0.71 (0.61 to 0.83) | −11.84 (−16.94 to −6.75) | ||
| Birth weight (g), mean (SD)‡ | n=1141, 2797 (438) | n=1094, 2816 (449) | n=955, 2785 (439) | n=934, 2744 (459) | — | 40.84 (7.84 to 73.84) | — | 35.97 (−0.17 to 72.12) | — | 77.67 (26.38 to 128.96) | ||
| Birth length (cm), mean (SD)§‡ | n=1161, 48.0 (2.1) | n=1102, 48.2 (2.1) | n=977, 48.0 (2.1) | n=940, 47.9 (2.2) | — | 0.17 (0.01 to 0.32) | — | 0.05 (−0.12 to 0.22) | — | 0.21 (−0.03 to 0.45) | ||
| Secondary | ||||||||||||
| Spontaneous preterm† | 99/1283 (7.7) | 122/1259 (9.7) | 62/1080, (5.7) | 106/1081 (9.8) | 1.14 (0.89 to 1.45) | 0.94 (−1.00 to 2.88) | 0.69 (0.53 to 0.90) | −2.93 (−4.88 to −0.98) | 0.79 (0.55 to 1.12) | −2.00 (−4.77 to 0.76) | ||
| Stunting† | 176/1161 (15.2) | 176/1102 (16.0) | 168/977 (17.2) | 198/939 (21.1) | 0.81 (0.69 to 0.96) | −3.18 (−5.91 to −0.45) | 0.84 (0.70 to 1.00) | −2.10 (−4.88 to 0.67) | 0.68 (0.53 to 0.87) | −5.32 (−9.42 to −1.22) | ||
| Head circumference (cm), mean (SD)‡ | n=1161, 33.1 (1.3) | n=1102, 33.1 (1.3) | n=976, 33.1 (1.4) | n=940, 33.0 (1.4) | — | 0.07 (−0.03 to 0.17) | — | 0.12 (0.01 to 0.23) | — | 0.18 (0.02 to 0.33) | ||
| Stillbirths† | 22/1312 (1.7) | 20/1296 (1.5) | 15/1108, (1.4) | 21/1114 (1.9) | 0.97 (0.56 to 1.67) | 0.01 (−0.89 to 0.87) | 1.17 (0.62 to 2.18) | −0.26 (−1.16 to 0.64) | 1.37 (0.59 to 3.19) | −0.26 (−1.55 to 1.04) | ||
Data are n/total (%) unless indicated otherwise.
ARR=absolute risk reduction; CI=confidence interval; IRR=incidence rate ratio; MD=mean difference; SD=standard deviation.
Weight on day 7 (up to +6 days). †Incidence rate ratio, ‡mean difference, adjusted for place of birth, family possesses below poverty line card, woman’s height, woman’s body mass index as potential confounders and twins for clustering within a household. 98.3% confidence interval for primary and secondary outcomes (to correct for multiple comparisons). §Length on days 1-7 (up to +6 days). ¶Absolute risk reduction, adjusted for place of birth, family possesses below poverty line card, woman’s height, woman’s body mass index for potential confounder and twins for clustering within the household.
Group A: preconception, pregnancy and early childhood intervention; group B: only preconception intervention; group C: only pregnancy and early childhood intervention; group D: control. Group A+B v group C+D: effect of preconception interventions: women who received interventions compared with those who did not receive preconception interventions; group A+C v group B+D: effect of pregnancy and early childhood interventions: women who received these interventions compared with those who did not receive these interventions; group A v group D: effect of preconception, pregnancy, and early childhood interventions: women who received interventions in these periods compared with those who received routine care.