O32 AVAILABILITY OF PROPERLY VALIDATED BLOOD PRESSURE MEASURING DEVICES FOR PREGNANT WOMEN: STRIDE BP SYSTEMATIC REVIEW

Background and Objective: Validated automated upper-arm cuff blood pressure (BP) measuring devices are currently recommended for BP measurement. However, a validated BP device in the general population may be inaccurate in pregnant women. Thus, separate validation studies are required in pregnant women with normal BP, hypertension, and preeclampsia. This study assessed the published evidence on BP devices in pregnancy. Methods: STRIDE BP (www.stridebp.org) performs periodic systematic PubMed searches to identify validation studies of automated cuff BP monitors. Validation studies in pregnancy conducted using an established protocol, including the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018), ANSI/AAMI/ISO 2013/2009, ESH-IP 2010/2002, AAMI 2002/1992/1987, and BHS 1993/1990, were identified. Results: Of 569 validation studies included in the STRIDE BP database, 63 (35 devices) were identified including pregnant women. Among them, STRIDE BP rejected 45 studies, of which 25 were reported as “device pass” in the published validation paper. Among the studies rejected by STRIDE BP but published as “pass”, the main reasons for rejection were violations in the BP measurement protocol (44%), inadequate reference device or cuffs for reference and test device (36%), no data in women with hypertension and/or preeclampsia (36%), single observer for reference BP measurement (28%), and inappropriate data analysis (20%). Eventually 18 studies in pregnant women (28.6%) fulfilled the protocol requirements, and 16 devices (8 of them available on the market) can be recommended for clinical use in pregnancy. When additional ‘equivalent’ devices were considered (devices lacking validation studies but with differences from validated devices not affecting the BP measurement accuracy), 37 devices were found to be accurate in pregnancy, with 27 of them available on the market (Table). Conclusions: This analysis showed a shortage of properly validated BP devices for pregnant women available in the market, with published validation often having major methodological issues. There is an urgent need to develop and properly validate more BP devices in pregnancy. TABLE. Validated devices for office, home, and ambulatory BP measurement in pregnant women.