Safety and impact of self-monitoring blood pressure through a digital platform in high-risk pregnancies in 11 hospitals: The multicenter before-after SAFE@home II study

OBJECTIVE(S): To investigate the safety and clinical effectiveness of telemonitoring of blood pressure and symptoms with SAFE@home combined with a hybrid care path in patients at increased risk of or with established hypertensive disorders of pregnancy, compared to usual care. STUDY DESIGN: A multicenter, non-randomized, non-inferiority before-after study was conducted in 11 Dutch hospitals. High-risk patients monitored for BP at home (SAFE@home cohort) were compared to a retrospective cohort receiving usual care. Patients with a singleton pregnancy and with risk of or established hypertensive disorders were eligible for inclusion. The primary outcome was a composite of maternal and neonatal adverse outcomes, with a non-inferiority margin set at 7% (corresponding OR 1.39). Secondary outcomes included oral antihypertensive use and pregnancy outcomes. Adjusted odds ratios (aOR) were calculated using multivariable logistic regression. RESULTS: In both groups 606 patients were included. The composite outcome occurred less frequently in the SAFE@home group (17.2 %) compared to the usual care group (21.5 %), (aOR 0.65, 95 %CI 0.46 - 0.92). Severe hypertension was reduced in the SAFE@home group (12.7 % vs. 17.5 %; aOR 0.60, 95 % CI 0.41 - 0.88). Rates for small for gestational age neonates (12.0 % vs. 18.2 %; aOR 0.69, 95 % CI 0.48 - 0.99) and medically indicated preterm birth < 34 weeks (3.6 % vs. 5.6 %; aOR 0.49, 95 % CI 0.26 - 0.91) were also lower in the SAFE@home group. CONCLUSION(S): Telemonitoring in high-risk pregnancies is safe, non-inferior to usual care, and also associated with better perinatal outcomes. Our research shows the clinical benefits and transformative potential of telemonitoring when managing high-risk pregnancies.