Objectives
To assess the Microlife 3AS1–2, a semi-automated oscillometric BP device, compared to mercury sphygmomanometry for use in pregnancy and pre-eclampsia in a low resource setting, according to the requirements of the British Hypertension Society (BHS) Protocol1 and the International Organisation of Standardisation (ISO).2
Methods
Prospective observational study, using validation methods recommended by the BHS. 45 pregnant subjects were recruited, including 15 with pre-eclampsia, 10 in their second trimester, 10 from their third trimester and 10 with an arm circumference >35 cm, from Kimberley Hospital, South Africa. All participants were provided with written consent. any subject with cardiac arrhythmia or unclear Korotkoff sounds was excluded.
Results
The Microlife 3AS1–2 device achieved an overall B/A grade, with an A/A grade in pregnancy excluding pre-eclampsia (n = 30) and passed all the BHS protocol requirements. The device achieved the ISO standard for mean difference and standard deviation (≤ 5 ± 8 mmHg) in pregnancy (including pre-eclampsia).
Conclusion
The Microlife 3AS1–2 device can be recommended for use in pregnancy, including pre-eclampsia, according to BHS and ISO protocols. As well as demonstrating accuracy in a low-resource pregnant population, it also fulfils all of the requirements stipulated by the World Health Organisation for an automated device suitable for use in a low-resource setting. This makes it the ideal device for use in antenatal clinics and primary health-care facilities in low- and middle-income countries.
References
International Standard (ISO). Non-invasive sphygmomanometers. Part 2: Clinical investigation of automated measurement type. 2013
O’Brien E, et al. The British Hypertension Society protocol for the evaluation of blood pressure measuring devices. J Hypertens. 1993;11(Suppl 2):S43–S62
ranged from 11%-61%; no guideline was deemed suitable for use. Only Swiss and Canadian guidelines were considered useable with significant modifications. Conclusion Several international guidelines on perinatal care of 22-25 wk GA infants exist. Using the AGREE-II tool, we identified many deficits in the quality of these guidelines. Not a single guideline was deemed suitable for use using the AGREE-II tool. Use of poorly developed guidelines may be detrimental to decision-making, thus there is a need for transparent and rigorous guidelines regarding the perinatal care of 22-25 wk GA infants.
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