Clinical Accuracy of the Withings BPM Connect for Self-Blood Pressure Measurements in Pregnancy and Pre-Eclampsia: Validation According to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard

BACKGROUND: Electronic devices for blood pressure (BP) measurements require independent clinical validation as recommended by various authorities/societies, both in general and special populations such as pregnancy. OBJECTIVE: To assess the accuracy of the Withings BPM Connect device in pregnancy and pre-eclampsia according to the Universal Standard Validation Protocol. METHODS: The Withings BPM Connect device measures BP at the brachial level using the oscillometric method. The study was performed according to the so-called “modified AAMI/ESH/ISO (ISO 81060-2:2018) protocol” or the “Universal Standard Protocol”. The validation study included 45 pregnant women in the second and third gestational trimester: 15 with pre-eclampsia, 15 with gestational hypertension and 15 normotensives. Differences between mercury sphygmomanometer BP measurements (reference) and device BP values (test) and their standard deviation (SD) were calculated. RESULTS: The mean differences between the mercury standard and device BP values in pregnancy (n = 45) were −0.5 ± 5.7 mmHg for systolic BP (SBP) and −0.8 ± 3.8 mmHg for diastolic BP (DBP). In the preeclamptic patients (n = 15), the mean differences were 0.14 ± 5.5 mmHg for SBP and 0.39 ± 3.7 mmHg for DBP. These results fulfilled the protocol requirements (<5 ± 8 mmHg). CONCLUSION: The Withings BPM Connect fulfills the validation protocol criteria in pregnancy and pre-eclampsia. Consequently, this device can be recommended for home BP measurements in this specific pregnancy population.