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.

Abstract

BackgroundElectronic 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.ObjectiveTo assess the accuracy of the Withings BPM Connect device in pregnancy and pre-eclampsia according to the Universal Standard Validation Protocol.MethodsThe 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.ResultsThe 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).ConclusionThe 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.