Table 3.
Secondary outcomes in women at time of second randomisation
| Preconception interventions | No preconception interventions | Incidence rate ratio or mean difference (98.3% CI) | Absolute risk reduction (%)‡ (98.3% CI) | |
|---|---|---|---|---|
| Reproductive tract infections, n/total (%)* | 427/2648 (16.1) | 533/2265 (23.5) | 0.68 (0.59 to 0.80) | −7.49 (−10.57 to −4.41) |
| Hypothyroidism, n/total (%)* | 255/2485 (10.3) | 259/2110 (12.3) | 0.83 (0.68 to 1.03) | −1.96 (−4.34 to 0.42) |
| Prediabetes or diabetes, n/total (%)* | 59/2139 (2.8) | 62/1896 (3.3) | 0.81 (0.52 to 1.25) | −0.35 (−1.62 to 0.93) |
| Hypertension, n/total (%)* | 51/1762 (2.9) | 45/1674 (2.7) | 1.04 (0.64 to 1.70) | 0.07 (−1.29 to 1.43) |
| Anaemia status | n=2560 | n=2147 | — | — |
| Haemoglobin levels (g/dL), mean (SD)† | 11.9 (1.0) | 11.4 (1.4) | 0.56 (0.48 to 0.64) | — |
| No anaemia* | 1302 (50.9) | 763 (35.5) | 1.43 (1.28 to 1.60) | 15.93 (11.39 to 20.47) |
| Mild anaemia* | 878 (34.3) | 691 (32.2) | 1.06 (0.94 to 1.20) | 1.96 (−2.08 to 5.99) |
| Moderate anaemia* | 375 (14.7) | 645 (30.0) | 0.49 (0.42 to 0.57) | −15.14 (−18.50 to −11.78) |
| Severe anaemia* | 5 (0.2) | 48 (2.2) | 0.09 (0.03 to 0.28) | −2.00 (−2.79 to −1.21) |
| Body mass index | n=2652 | n=2269 | — | — |
| ≥25* | 666 (25.1) | 569 (25.1) | 1.00 (0.87 to 1.15) | 0.05 (−3.39 to 3.50) |
| 18.5-24.99* | 1617 (61.0) | 1339 (59.0) | 1.03 (0.95 to 1.13) | 1.93 (−3.37 to 7.23) |
| <18.5* | 369 (13.9) | 361 (15.9) | 0.88 (0.73 to 1.05) | −1.98 (−4.64 to 0.68) |
| Birth interval | ||||
| Months between previous birth and pregnancy | n=1500 | n=1325 | — | — |
| Mean (SD)† | 38.8 (23.1) | 38.6 (20.9) | 0.11 (−1.84 to 2.05) | — |
| Median (IQR) | 33.4 (22.2-50.3) | 34.8 (23.0-49.2) | — | — |
| Months between marriage and pregnancy | n=1147 | n=943 | — | — |
| Mean (SD)† | 20.4 (18.0) | 20.6 (18.0) | −0.41 (−2.29 to 1.47) | — |
| Median (IQR) | 15.3 (7.9-26.6) | 15.6 (8.3-26.8) | — | — |
| PHQ-9 score ≥10, n/total (%)* | 60/2648 (2.3) | 55/2255 (2.4) | 0.92 (0.59 to 1.43) | −0.27 (−1.35 to 0.82) |
Data are numbers (%) unless indicated otherwise. Reproductive tract infection based on symptoms: any symptoms of vaginal discharge, itching, burning, swelling, ulcer in genital region, swelling and pain lower abdomen; hypothyroidism: thyroid stimulating hormone ≥4.0 mIU/mL; prediabetes or diabetes: HbA1c>5.7%; hypertension: systolic blood pressure ≥140 mm Hg and diastolic blood pressure ≥90 mm Hg; no anaemia: haemoglobin (Hb)≥12g/dL; mild anaemia: Hb 10-11.99 g/dL; moderate anaemia: Hb 8-9.99 g/dL; severe anaemia: Hb<8g/dL.
CI=confidence interval; IQR=interquartile range; PHQ-9=patient health questionnaire; SD=standard deviation.
Incidence rate ratio (98.3% CI), †mean difference (98.3% CI), adjusted for family possesses below poverty line card, woman’s height, woman’s body mass index; not corrected for multiple outcomes or comparisons. ‡Absolute risk reduction (98.3% CI), adjusted for family possesses below poverty line card, woman’s height, woman’s body mass index.