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Accuracy of Blood Pressure Measurement Devices in Pregnancy: A Systematic Review of Validation Studies
Natalie A Bello1, Jonathan J Woolley2, Kirsten Lawrence Cleary2
1From the Department of Medicine (N.A.B., L.F., D.S.) and Department of Obstetrics and Gynecology (K.L.C., R.W.), Columbia University Medical Center, New York, NY; Department of Economics, California Polytechnic State University, San Luis Obispo (J.J.W.); Department of Pediatrics, University of Tennessee Health Science Center, Memphis (B.S.A.); and Department of Medicine (S.O.), Department of Biostatistics (G.C.), Department of Epidemiology (P.M.), and Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama at Birmingham. nb338@columbia.edu.
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.
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