Validation Study of the Withings BPM Pro 2 Blood Pressure Device in Pregnant Women with Hypertension and Pre-Eclampsia

What this Trial Is About

Researchers are evaluating the accuracy of the Withings BPM Pro 2, an automatic oscillometric blood pressure measuring device used at the arm level, specifically in pregnant women and those with pre-eclampsia. The study aims to validate this device according to the Universal Protocol for Blood Pressure Measuring Devices by leading medical organizations. It includes participants who are pregnant in their second or third trimester, with varying blood pressure conditions including normotension, hypertension, or pre-eclampsia. Participants will have their blood pressure measured alternately using a standard reference mercury sphygmomanometer four times and the Withings BPM Pro 2 device three times. This process is applied to all patients consenting and meeting the inclusion criteria. The study does not involve blinding or multiple arms beyond this device evaluation. During the five-month study period, participants will undergo these blood pressure measurements to assess the devices performance. Researchers will monitor blood pressure results carefully to determine accuracy compared to the reference method. Participants must have an arm circumference between 22 cm and 42 cm and be followed at the study site either as in-patient or out-patient. The study ensures ongoing safety by excluding patients with certain medical conditions or inability to consent.

Clinical Validation of the Blood Pressure Measuring Device Withings BPM Pro 2 in Pregnancy and Pre-Eclampsia