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.