Table 3.
Maternal Outcomes.*
| Outcome | Active Treatment (N = 1208) | Control (N = 1200) | Treatment Effect (95% CI)† |
|---|---|---|---|
| Composite cardiovascular complications — no. (%) | 25 (2.1) | 33 (2.8) | 0.75 (0.45 to 1.26) |
| Maternal death | 1 (0.1) | 2 (0.2) | 0.50 (0.05 to 5.47) |
| Heart failure | 1 (0.1) | 1 (0.1) | 0.99 (0.06 to 15.9) |
| Stroke | 0 | 0 | NA |
| Myocardial infarction or angina | 0 | 0 | NA |
| Pulmonary edema | 5 (0.4) | 11 (0.9) | 0.45 (0.16 to 1.30) |
| ICU admission or intubation | 12 (1.0) | 16 (1.3) | 0.75 (0.35 to 1.57) |
| Encephalopathy | 1 (0.1) | 0 | 1.00 (1.00 to 1.00) |
| Renal failure | 9 (0.8) | 14 (1.2) | 0.64 (0.28 to 1.47) |
| Severe hypertension — no. (%) | 436 (36.1) | 531 (44.3) | 0.82 (0.74 to 0.90) |
| Any preeclampsia — no. (%) | 295 (24.4) | 373 (31.1) | 0.79 (0.69 to 0.89) |
| Severe hypertension plus proteinuria | 189 (15.7) | 215 (17.9) | 0.87 (0.73 to 1.04) |
| Eclampsia | 0 | 1 (0.1) | NA |
| HELLP | 0 | 3 (0.3) | NA |
| Hypertension plus end-organ dysfunction | 136 (11.3) | 181 (15.1) | 0.75 (0.61 to 0.92) |
| Nonsevere preeclampsia | 23 (1.9) | 37 (3.1) | 0.62 (0.37 to 1.03) |
| Worsening chronic hypertension — no. (%) | 132 (10.9) | 156 (13.0) | 0.84 (0.68 to 1.04) |
| Mean blood pressure during prenatal visits — mm Hg‡ | |||
| Systolic | 129.5±10.0 | 132.6±10.1 | −3.11 (−3.95 to 2.28) |
| Diastolic | 79.1±7.4 | 81.5±8.0 | −2.33 (−2.97 to 0.04) |
| Gestational age at delivery — wk§ | 36.6±4.3 | 36.3±5.1 | 0.24 (−0.15 to 0.62) |
| Cesarean delivery — no. (%) | 592 (49.0) | 582 (48.5) | 1.01 (0.93 to 1.10) |
| Any blood transfusion — no. (%) | 46 (3.8) | 53 (4.4) | 0.86 (0.59 to 1.27) |
Plus–minus values are means αSD. Data are shown for all the patients who underwent randomization, regardless of adherence to group assignment. HELLP denotes hemolysis, elevated liver enzymes, and low platelets, ICU intensive care unit, and NA not applicable.
The treatment effect is a risk ratio unless otherwise indicated.
The treatment effect for blood pressure during prenatal visits is the between-group difference. Data in this category were missing for 71 patients in the active-treatment group and for 79 in the control group.
The treatment effect for mean gestational age at delivery is the between-group difference. Data in this category were missing for 27 patients in the active-treatment group and for 36 in the control group.