Key result
Withings BPM Connect accurately measures pregnancy BP within ~1 mmHg of standard mercury sphygmomanometers.
Why the study?
Electronic devices for blood pressure measurements require independent clinical validation in general and special populations such as pregnancy.
Does the Withings BPM Connect device accurately measure blood pressure compared to a mercury sphygmomanometer in pregnant women and those with pre-eclampsia?
Cross-Sectional (n=45)
Does the Withings BPM Connect device accurately measure blood pressure compared to a mercury sphygmomanometer in pregnant women and those with pre-eclampsia?
The Withings BPM Connect device meets the Universal Standard Validation Protocol criteria for accurate blood pressure measurement in pregnant women, including those with pre-eclampsia.
May support home BP monitoring in pregnancy; leaves open larger outcome trials in preeclampsia.
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.
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A 2022 study conducted a cross-sectional in Pregnancy and pre-eclampsia (n=45). Withings BPM Connect device vs. Mercury sphygmomanometer was evaluated on Mean difference between device and mercury sphygmomanometer blood pressure measurements (MD -0.5 ± 5.7 mmHg (SBP) and -0.8 ± 3.8 mmHg (DBP)). The Withings BPM Connect accurately measured blood pressure in pregnancy, with mean differences versus mercury sphygmomanometer of -0.5 ± 5.7 mmHg (systolic) and -0.8 ± 3.8 mmHg (diastolic).
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