Accuracy of Blood Pressure Measurement Devices in Pregnancy

Abstract

The accurate measurement of blood pressure (BP) in pregnancy is essential to guide medical decision making that affects both mother and fetus. The aim of this systematic review was to determine the accuracy of ambulatory, home, and clinic BP measurement devices in pregnant women. We searched Ovid MEDLINE, The Cochrane Library, EMBASE, CINAHL EBSCO, ClinicalTrials.gov, International Clinical Trials Registry Platform, and dabl from inception through August 3, 2017 for articles that assessed the validity of an upper arm BP measurement device against a mercury sphygmomanometer in pregnant women. Two independent investigators determined eligibility, extracted data, and adjudicated protocol violations. From 1798 potential articles identified, 41, that assessed 28 devices, met the inclusion criteria. Most articles (n=32) followed a standard or modified American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization, British Hypertension Society, or European Society of Hypertension validation protocol. Several articles described the results of validation studies performed on>1 device (n=7) or in >1 population of pregnant women (n=12), comprising 64 pairwise validity assessments. The device was validated in 61% (32 of 52) of studies which used a standard or modified protocol. Only 34% (11 of 32) of the studies wherein the device was successfully validated were performed without a protocol violation. Given the implications of inaccurate BP measurement in pregnant women, healthcare providers should be aware of and try to use the BP measurement devices which have been properly validated in this population.

Validation of the SunTech Medical Advantage Model 2 Series Automated Blood Pressure Module in Pregnancy

“…There are only a few commercially available noninvasive blood pressure devices in the United States validated to measure blood pressure in pregnancy. 3,4,6,14,15 Of these, only three devices available for inpatient or ambulatory clinical use are validated in women with preeclampsia, 3 and just one device (GE Dinamap ProCare 400) is currently available in the United States (Personal Communication with GE Healthcare and Omron Healthcare on March 8, 2018). Further, studies have demonstrated that automated noninvasive blood pressure devices commonly underestimate systolic and diastolic blood pressures in women with preeclampsia.…”

“…Of these, just three have been validated in patients with preeclampsia. 3 Further, only one device (GE Dinamap 400) is available in the United States (Personal Communication with GE Healthcare and Omron Healthcare on March 7, 2018). While diagnosis and treatment plans hinge on accurate measurement of blood pressures, the use of nonvalidated automated blood pressure devices (assuming the mercury sphygmomanometer is the gold standard) may lead to the misdiagnosis of patients with hypertensive disorders of pregnancy.…”

Out of Office Blood Pressure Measurement in Pregnancy and the Postpartum Period

“…As such, guidelines recommend separately validating BP measurement devices for accuracy among pregnant women [34–37]. A systematic review of validation studies of office, ambulatory, and home BP measurement devices in pregnant women found 61% of devices specifically validated for use in pregnancy passed the validation study, though only 34% of studies were performed without any protocol violation [38]. There are currently few ABPM or HBPM devices that have been consistently validated for accuracy in women with preeclampsia [38, 39].…”

Clinical accuracy of the Omron M3 Comfort^® and the Omron Evolv^® for self-blood pressure measurements in pregnancy and pre-eclampsia – validation according to the Universal Standard Protocol

“…These hemodynamic changes are more pronounced in pre-eclampsia suggesting that automatic devices for BP measurements tend to underestimate BP in these conditions 18. Considering that hypertension in pregnancy is common and has been reported to occur in up to 10% of pregnancies; accurate BP measurements is of paramount importance in diagnosing and monitoring high-risk pregnant women 12. In this regard, the validation protocols recommend, for BP devices designed to be used in pregnancy, to go through specific validation of their accuracy in this specific population.…”

“…In this regard, the validation protocols recommend, for BP devices designed to be used in pregnancy, to go through specific validation of their accuracy in this specific population. Only few devices have been shown to be accurate in pregnant women with and without pre-eclampsia 12,19,20. In a recent review,19 among the 36 validations of home BP monitors, 25 validations were performed according to the BHS or a modified BHS protocol and 11 according to the AAMI protocol whereas the most popular and most used validation protocol in the general population is the ESH protocol.…”