Table 3.
Secondary and Safety Outcomes in the India and Tanzania Trials.*
| Outcome | India Trial | Tanzania Trial | ||||
|---|---|---|---|---|---|---|
| 500 mg Calcium | 1500 mg Calcium | Relative Risk or Incidence Rate Ratio (95% CI) | 500 mg Calcium | 1500 mg Calcium | Relative Risk or Incidence Rate Ratio (95% CI) | |
| Secondary outcomes | ||||||
| Gestational hypertension — no./total no. (%)† | 176/5477 (3.2) | 207/5468 (3.8) | 0.85 (0.70–1.03) | 225/5481 (4.1) | 220/5469 (4.0) | 1.02 (0.85–1.22) |
| Preeclampsia with severe features — no./total no. (%) | 61/5497 (1.1) | 97/5503 (1.8) | 0.63 (0.46–0.87) | 100/5503 (1.8) | 94/5497 (1.7) | 1.06 (0.80–1.40) |
| Pregnancy-related death — no./total no. (%) | 2/5497 (0.04) | 2/5503 (0.04) | 1.00 (0.14–7.10) | 4/5503 (0.1) | 3/5497 (0.1) | 1.33 (0.30–5.95) |
| Fetal death — no./total no. (%) | 284/5479 (5.2) | 277/5470 (5.1) | 1.03 (0.87–1.20) | 362/5471 (6.6) | 391/5472 (7.2) | 0.93 (0.81–1.07) |
| Stillbirth at ≥28 wk of gestation — no./total no. (%) | 110/5305 (2.1) | 120/5313 (2.3) | 0.92 (0.71–1.18) | 165/5274 (3.1) | 158/5239 (3.0) | 1.05 (0.85–1.30) |
| Birth weight <2500 g — no./total no. (%) | 898/5195 (17.3) | 910/5193 (17.5) | 0.98 (0.90–1.06) | 448/5095 (8.8) | 438/5066 (8.7) | 1.03 (0.90–1.18) |
| Small-for-gestational-age status <10th percentile — no./total no. (%) | 1703/5195 (32.8) | 1777/5193 (34.2) | 0.96 (0.90–1.01) | 1133/5095 (22.2) | 1112/5066 (22.0) | 1.02 (0.94–1.09) |
| Infant death at <42 days — no./total no. (%) | 25/5195 (0.5) | 15/5193 (0.3) | 1.60 (0.84–3.06) | 84/5109 (1.6) | 93/5081 (1.8) | 0.90 (0.67–1.22) |
| Safety outcomes | ||||||
| Maternal hospitalization — no. of hospitalizations/no. of person-mo | 11/43,223 | 24/43,332 | 0.46 (0.22–0.94) | 40/38,164 | 25/38,705 | 1.60 (0.97–2.63) |
| Maternal third-trimester severe anemia — no./total no. (%)‡ | 1/4475 (<0.1) | 2/4478 (<0.1) | 0.50 (0.05–5.52) | 0/4229 | 0/4215 | — |
*
Relative risks are shown for all secondary and safety outcomes except for the repeatable safety event of maternal hospitalization, for which incidence rate ratios are shown. For these nonprimary outcome analyses, the 95% confidence intervals are not adjusted for multiplicity and should not be used to infer definitive treatment effects.
†
The analysis of gestational hypertension excluded participants with chronic hypertension (20 participants in the 500-mg group and 35 in the 1500-mg group in the India trial, and 22 and 28 participants, respectively, in the Tanzania trial).
‡
Severe anemia was defined as a hemoglobin concentration of less than 7.0 g per deciliter.