Table 3. Selected Secondary Maternal and Perinatal Outcomes by Randomized Groupa.
| No./total (%) | Adjusted absolute difference, % (95% CI)b | Adjusted risk ratio (95% CI)b | P value for treatment effect | ||
|---|---|---|---|---|---|
| Self-monitoring group | Usual care group | ||||
| Maternal | |||||
| Severe hypertension | 69/1171 (6.0) | 57/1175 (4.9) | 1.09 (−0.94 to 3.12) | 1.22 (0.87 to 1.70) | .25 |
| Preeclampsia | 51/1209 (4.2) | 51/1209 (4.2) | 0.01 (−1.84 to 1.85) | 1.00 (0.66 to 1.51) | >.99 |
| ≥1 Serious maternal complicationsc | 15/1209 (1.2) | 19/1209 (1.6) | |||
| Perinatal | |||||
| Gestation at delivery, median (IQR), wk | 39.3 (38.1 to 40.4) [1190] | 39.3 (38.0 to 40.4) [1185] | 0.14 (−0.01 to 0.30)d | ||
| Stillbirth | 5/1260 (0.4) | 3/1248 (0.2) | |||
| Neonatal death within 7 d | 2/1248 (0.2) | 0/1240 | |||
| Small for gestational age (<10th percentile) | 104/1249 (8.3) | 87/1235 (7.0) | 1.10 (−1.09 to 3.29) | 1.15 (0.87 to 1.53) | .32 |
| Infant admitted to neonatal intensive care unit | 161/1248 (12.9) | 163/1240 (13.1) | −0.64 (−3.34 to 2.05) | 0.95 (0.77 to 1.17) | .63 |
See eTables 3 and 4 in Supplement 3 for additional maternal and perinatal outcomes.
Statistical comparisons completed when >2% event rate for self-monitoring vs usual care. Log-Poisson generalized linear mixed-effects model with robust standard errors adjusted for randomized group and parity as fixed effects; and site as a random effect. Level of significance P < .05.
One or more of the following: eclampsia, transient ischemic attack or stroke, HELLP syndrome (hemolysis, elevated liver enzymes, low platelets), liver involvement (ALT or AST >70 U/L), pulmonary edema, kidney involvement (creatinine ≥90 μmol/L), and hematological involvement (platelets < x100^9/L).
Estimated median difference (95% CI) derived from quantile regression adjusted for randomized arm, parity, and site.