ABSTRACT
OBJECTIVE: To assess the accuracy of an automated blood pressure device (Microlife 3BTO-A) in pregnancy and pre-eclampsia according to the British Hypertension Society (BHS) protocol. DESIGN: Prospective observational study. SETTING: Antenatal ward and clinics at Guy's and St Thomas' Hospital, London, UK. POPULATION: One hundred and five pregnant women including 35 women with non-proteinuric hypertension and 35 with pre-eclampsia. METHODS: Two trained observers took nine sequential same-arm measurements from each woman. Measurements alternated between a mercury sphygmomanometer and the device. MAIN OUTCOME MEASURES: Grading criteria of the BHS protocol (A/B grade = pass; C/D grade = fail). RESULTS: The device passed the BHS protocol by achieving an A/B grade. It also achieved criteria of the Association for the Advancement of Medical Instrumentation for systolic and diastolic pressures respectively, in normotensive [-0.5 (5.7) mmHg; -0.07 (7.7) mmHg], non-proteinuric hypertensive [-3.3 (6.9) mmHg; -2.4 (6.6) mmHg] and pre-eclamptic pregnancy [-4.1 (6.4) mmHg; -1.3 (7.9) mmHg]. CONCLUSION: The Microlife 3BTO-A can be recommended for use in a pregnant population, including pre-eclampsia, according to the BHS protocol.
Subject(s)
Blood Pressure Determination/instrumentation , Pre-Eclampsia/physiopathology , Adult , Automation , Blood Pressure/physiology , Blood Pressure Determination/standards , Female , Humans , Hypertension, Pregnancy-Induced/physiopathology , Observer Variation , Pregnancy , Sensitivity and SpecificityABSTRACT
OBJECTIVE: To establish the accuracy the Welch Allyn 'Vital Signs' blood pressure monitor in pregnancy and pre-eclampsia according to a modified British Hypertension Society protocol. DESIGN: Prospective observational study. SETTING: Maternity Unit/Obstetric Ward, Guy's and St Thomas' Hospital, London, UK. POPULATION: Forty-three pregnant women of whom 12 had pre-eclampsia. METHODS: Nine sequential same-arm measurements were taken from each woman by two trained observers, alternating between a mercury sphygmomanometer and the device. The last seven readings were analysed according to the British Hypertension Society protocol. The accuracy of the device was determined using the grading scale indicated by the British Hypertension Society protocol (grade A/B = pass, grade C/D = fail). MAIN OUTCOME MEASURES: Grading criteria of the British Hypertension Society Protocol. RESULTS: The Welch Allyn 'Vital Signs' monitor achieved a grade A for both systolic and diastolic pressures in pregnant women who did not have pre-eclampsia. In those women with pre-eclampsia, it achieved a grade D and B for systolic and diastolic pressures, respectively. The mean differences between the observers and the device in women without pre-eclampsia were -2.6 (6.4) and -1.5 (7.2) mmHg for systolic and diastolic pressures [and in pre-eclamptic women -7.8 (6.3) and -5.5 (6.5)mmHg]. It therefore fulfils criteria set by the Association for the Advancement of Medical Instrumentation (mean <5 mmHg and standard deviation <8 mmHg) in pregnancy, but not in pre-eclampsia. CONCLUSION: This is the first automated device suitable for robust clinical use that can be recommended for use in pregnancy. However, it should be borne in mind that-similar to other devices--it significantly under--recorded readings obtained in pre-eclamptic women.