Validation of the Spacelabs 90227 OnTrak device according to the European and British Hypertension Societies as well as the American protocols.

OBJECTIVE: To assess the static device accuracy of the Spacelabs 90227 OnTrak according to the three most recognized validation protocols, in both adults and children. METHODS: Subjects were recruited and data gathered and analysed according to the European Society of Hypertension (ESH-IP2), the British Hypertension Society (BHS) and the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Standards Organization (ANSI/AAMI/ISO) protocols. RESULTS: The device achieved a mean difference ± SD between observers and device for SBP/DBP was 0.9 ± 7/-1.4 ± 6 mmHg (ESH-IP2) and 1.7 ± 8/-1.5/6 mmHg (BHS) Grade A/A. For the ANSI/AAMI/ISO protocol, the average device-observer difference for SBP/DBP was 0.4 ± 7/-1.5 ± 7 mmHg fulfilling the two criteria of the protocol. CONCLUSION: The Spacelabs 90227 OnTrak device achieved the criteria of all three recognised validation protocols and can therefore be recommended for clinical use as a static device.

Pregnancy-Related Acute Kidney Injury in Preeclampsia: Risk Factors and Renal Outcomes.

Preeclampsia is a common cause of acute kidney injury (AKI) in low- and middle-income countries, but AKI incidence in preeclampsia, its risk factors, and renal outcomes are unknown. A prospective observational multicenter study of women admitted with preeclampsia in South Africa was conducted. Creatinine concentrations were extracted from national laboratory databases for women with maximum creatinine of ≥90 µmol/L (≥1.02 mg/dL). Renal injury and recovery were defined by Kidney Disease Improving Global Outcomes creatinine criteria. Predefined risk factors, maternal outcomes, and neonatal outcomes were compared between AKI stages. Of 1547 women admitted with preeclampsia 237 (15.3%) met AKI criteria: 6.9% (n=107) stage 1, 4.3% (n=67) stage 2, and 4.1% (n=63) stage 3. There was a higher risk of maternal death (n=7; relative risk, 4.3; 95% CI, 1.6-11.4) and stillbirth (n=80; relative risk, 2.2; 95% CI, 1.8-2.8) in women with AKI compared with those without. Perinatal mortality was also increased (89 of 240; 37.1%). Hypertension in a previous pregnancy was the strongest predictor of AKI stage 2 or 3 (odds ratio, 2.24; 95% CI, 1.21-4.17). Renal recovery rate reduced with increasing AKI stage. A third of surviving women (76 of 230 [33.0%]) had not recovered baseline renal function by discharge. Approximately half (39 of 76; 51.3%) of these women had no further creatinine testing post-discharge. In summary, AKI was common in women with preeclampsia and had high rates of associated maternal and perinatal mortality. Only two-thirds of women had confirmed renal recovery. History of a previous hypertensive pregnancy was an important risk factor.

Shock index thresholds to predict adverse outcomes in maternal hemorrhage and sepsis: A prospective cohort study.

INTRODUCTION: Shock index (SI) is a predictor of hemodynamic compromise in obstetric patients. The SI threshold for action is not well understood. We aimed to evaluate SI thresholds as predictors of outcomes in obstetric patients. MATERIAL AND METHODS: We undertook a prospective cohort study at three South African hospitals of women with postpartum hemorrhage (n = 283) or maternal sepsis (n = 126). The "first" and "worst" SI following diagnosis were recorded. SI was compared with conventional vital signs as predictors of outcomes. The performance of SI <.9, SI .9-1.69 and SI ≥1.7 to predict outcomes (maternal death; Critical Care Unit admission; major procedure; hysterectomy) and hemorrhage-specific outcomes (lowest hemoglobin <70 g/l; blood transfusion ≥4 IU) were evaluated. RESULTS: "First" SI was one of two best performing vital signs for every outcome in postpartum hemorrhage and sepsis. In hemorrhage, risk of all outcomes increased with increasing "first" SI; for blood transfusion ≥4 IU odds ratio was 4.24 (95% confidence interval 1.25-14.36) for SI ≥1.7 vs SI .9-1.69. In sepsis, risk of all outcomes increased with increasing "worst" SI. Sensitivity, specificity, positive and negative predictive values of "first" SI <.9 vs SI ≥.9 for maternal death were 100.0%, 55.2%, 4.6% and 100.0%, respectively, in hemorrhage and 80.0%, 50.4%, 12.3% and 96.7%, respectively, in sepsis. CONCLUSIONS: The shock index was a consistent predictor of outcomes compared with conventional vital signs in postpartum hemorrhage and sepsis. SI <.9 performed well as a rule-out test and SI .9-1.69 and SI ≥1.7 indicated increased risk of all outcomes in both cohorts. These thresholds may alert to the need for urgent intervention and prevent maternal deaths.

Development and evaluation of a novel Vital Signs Alert device for use in pregnancy in low-resource settings.

OBJECTIVES: Haemorrhage, hypertension, sepsis and abortion complications (often from haemorrhage or sepsis) contribute to 60% of all maternal deaths. Each is associated with vital signs (blood pressure (BP) and pulse) abnormalities, and the majority of deaths are preventable through simple and timely intervention. This paper presents the development and evaluation of the CRADLE Vital Signs Alert (VSA), an accurate, low-cost and easy-to-use device measuring BP and pulse with an integrated traffic light early warning system. The VSA was designed to be used by all cadres of healthcare providers for pregnant women in low-resource settings with the aim to prevent avoidable maternal mortality and morbidity. METHODS: The development and the mixed-methods clinical evaluation of the VSA are described. RESULTS: Preliminary fieldwork identified that introduction of BP devices to rural clinics improved antenatal surveillance of BP in pregnant women. The aesthetics of the integrated traffic light system were developed through iterative qualitative evaluation. The traffic lights trigger according to evidence-based vital sign thresholds in hypertension and haemodynamic compromise from haemorrhage and sepsis. The VSA can be reliably used as an auscultatory device, as well as its primary semiautomated function, and is suitable as a self-monitor used by pregnant women. CONCLUSION: The VSA is an accurate device incorporating an evidence-based traffic light early warning system. It is designed to ensure suitability for healthcare providers with limited training and may improve care for women in pregnancy, childbirth and in the postnatal period.

Maternal and perinatal adverse outcomes in women with pre-eclampsia cared for at facility-level in South Africa: a prospective cohort study.

BACKGROUND: Hypertensive disorders of pregnancy contribute to 14% of all maternal deaths, the majority of which occur in low- and middle-income countries. The aim of the study was to describe the maternal and perinatal clinical outcomes of women with pre-eclampsia living in middle- and low-income countries. METHODS: The study was a prospective observational study of women with pre-eclampsia (n = 1547, 42 twin pregnancies) at three South African tertiary facilities. Using stepwise logistic regression model area under the receiver operating characteristic curve (AUROC) values, the association between maternal baseline and admission characteristics and risk of adverse outcomes was evaluated. Main outcome measures were eclampsia, kidney injury and perinatal death. RESULTS: In 1547 women with pre-eclampsia, 16 (1%) died, 147 (9.5%) had eclampsia, four (0.3%) had a stroke and 272 (17.6%) had kidney injury. Of the 1589 births, there were 332 (21.0%) perinatal deaths; of these, 281 (84.5%) were stillbirths. Of 1308 live births, 913 (70.0%) delivered <37 completed weeks and 544 (41.7%) delivered <34 weeks' gestation. Young maternal age (AUROC = 0.76, 95% confidence interval (CI) = 0.71-0.80) and low Body Mass Index BMI (AUROC 0.65, 95% CI = 0.59-0.69) were significant predictors of eclampsia. Highest systolic blood pressure had the strongest association with kidney injury, (AUROC = 0.64, 95% CI = 0.60-0.68). Early gestation at admission was most strongly associated with perinatal death (AUROC = 0.81, 95% CI = 0.77-0.84). CONCLUSIONS: The incidence of pre-eclampsia complications, perinatal death and preterm delivery in women referred to tertiary care in South Africa was much higher than reported in other low- and middle-income studies and despite access to tertiary care interventions. Teenage mothers and those with low BMI were at highest risk of eclampsia. This information could be used to inform guidelines, the research agenda and policy.

The CRADLE vital signs alert: qualitative evaluation of a novel device designed for use in pregnancy by healthcare workers in low-resource settings.

BACKGROUND: Vital signs measurement can identify pregnant and postpartum women who require urgent treatment or referral. In low-resource settings, healthcare workers have limited access to accurate vital signs measuring devices suitable for their environment and training. The CRADLE Vital Signs Alert (VSA) is a novel device measuring blood pressure and pulse that is accurate in pregnancy and designed for low-resource settings. Its traffic light early warning system alerts healthcare workers to the need for escalation of care for women with hypertension, haemorrhage or sepsis. This study evaluated the usability and acceptability of the CRADLE VSA device. METHODS: Evaluation was conducted in community and primary care settings in India, Mozambique and Nigeria and tertiary hospitals in South Africa. Purposeful sampling was used to convene 155 interviews and six focus groups with healthcare workers using the device (n = 205) and pregnant women and their family members (n = 41). Interviews and focus groups were conducted in the local language and audio-recorded, transcribed and translated into English for analysis. Thematic analysis was undertaken using an a priori thematic framework, as well as an inductive approach. RESULTS: Most healthcare workers perceived the CRADLE device to be easy to use and accurate. The traffic lights early warning system was unanimously reported positively, giving healthcare workers confidence with decision-making and a sense of professionalism. However, a minority in South Africa described manual inflation as tiring, particularly when measuring vital signs in obese and hypertensive women (n = 4) and a few South African healthcare workers distrusted the device's accuracy (n = 7). Unanimously, pregnant women liked the CRADLE device. The traffic light early warning system gave women and their families a better understanding of the importance of vital signs in pregnancy and during the postpartum period. CONCLUSION: The CRADLE device was well accepted by healthcare workers from a range of countries and levels of facility, including those with no previous vital signs measurement experience. The device motivated women to attend primary care and encouraged them to accept treatment and referral.

Early warning system hypertension thresholds to predict adverse outcomes in pre-eclampsia: A prospective cohort study.

OBJECTIVES: To evaluate the association between blood pressure (BP) measurements and adverse outcomes in women with pre-eclampsia. STUDY DESIGN: A prospective cohort study of women with pre-eclampsia admitted to three South African tertiary facilities. BP was measured using the CRADLE Vital Signs Alert (VSA), incorporated with a traffic light early warning system; green: systolic BP <140 mmHg and diastolic BP <90 mmHg, yellow: systolic BP 140-159 and/or diastolic BP 90-109 mmHg (but neither is above the upper threshold), red: systolic BP ≥160 mmHg and/or diastolic BP ≥110 mmHg. MAIN OUTCOME MEASURES: Maternal: death, eclampsia, stroke, kidney injury; process measures: magnesium sulfate use, Critical Care Unit (CCU) admission; perinatal: stillbirth, neonatal death, preterm delivery. RESULTS: Of 1547 women with pre-eclampsia (including 42 twin pregnancies), 33.0% of women triggered a red light on admission and 78.6% at their highest BP. Severe hypertension and adverse outcomes were common across yellow and red categories. Comparing admission red to yellow lights, there was a significant increase in kidney injury (OR 1.74, CI 1.31-2.33, trend test p = .003), magnesium sulfate use (OR 3.40, CI 2.24-5.18, p < .001) and CCU admission (OR 1.50, CI 1.18-1.91, p < .001), but not for maternal death, eclampsia, extended perinatal death or preterm delivery. CONCLUSION: The CRADLE VSA, with integrated traffic light early warning system, can identify women who are hypertensive, at increased risk of severe pre-eclampsia complications and in need of escalation of care. Women who triggered a red light were at increased risk of kidney injury, magnesium sulfate use and CCU admission.

Accuracy validation of the Microlife 3AS1-2 blood pressure device in a pregnant population with low blood pressure.

OBJECTIVE: To assess the accuracy of the Microlife 3AS1-2 blood pressure (BP) device in pregnant women with low BP to investigate suitability for hypotensive detection in low-income and middle-income countries. METHODS: A prospective observational study was carried out evaluating the Microlife 3AS1-2, a hand-held, upper-arm, semiautomated BP device, according to British Hypertension Society (BHS) protocol methods. Thirty (stable) pregnant women with a clinical systolic BP less than 100 mmHg and/or diastolic BP less than 60 mmHg were recruited from antenatal wards and clinics and their BP was measured by three trained observers at a district-level hospital in South Africa. Accuracy was assessed according to the BHS grading criteria (A/B=pass) and the ANSI/AAMI/ISO standard for mean difference and SD (≤5±8 mmHg). RESULTS: The device achieved an A/A grade according to the BHS grading criteria. The mean difference±SD between the observer and the test device was 0.5±6.2 and 1.3±5.4 mmHg for systolic and diastolic BP, respectively, fulfilling the standard required by the ANSI/AAMI/ISO protocol. All observer differences were within 4 mmHg. CONCLUSION: According to the BHS protocol, the Microlife 3AS1-2 BP device is accurate in pregnant women with low BP. The device has been validated previously in pregnancy and pre-eclampsia and also fulfils the criteria of the WHO for use in a low-resource setting. Although unstable women were not included in this validation (for safety and pragmatic reasons), this device could potentially improve the detection of shock secondary to obstetric haemorrhage or sepsis, as well as being used in pre-eclampsia, particularly in low-income and middle-income countries.

Clinical accuracy of a low cost portable blood pressure device in pregnancy and pre-eclampsia: the Nissei DS-400.

Hypertensive disorders of pregnancy cause significant maternal morbidity and mortality worldwide, particularly in developing countries. This study evaluated the accuracy of the Nissei DS-400, a low cost blood pressure (BP) device, in pregnancy according to the British Hypertension Society protocol. Forty-five pregnant women (15 with pre-eclampsia), were recruited from a large teaching hospital. Nine sequential same-arm BP measurements were taken from each woman by trained observers, alternating between mercury sphygmomanometry and the device. The Nissei DS-400 achieved the highest accuracy grade (A/A) in all subjects (n = 45) and in pregnancy alone (n = 30). The mean difference ± standard deviation between the standard and the device in pregnancy were -1.0 ± 5.1 mmHg and -1.1 ± 5.0 mmHg for systolic and diastolic BP, respectively, and -2.6 ± 5.9 mmHg and -3.4 ± 5.8 mmHg in all subjects. The Nissei-DS 400 can be recommended for clinical use in pregnancy and has potential as a good screening tool for pre-eclampsia in low resource settings.

An accurate semiautomated oscillometric blood pressure device for use in pregnancy (including pre-eclampsia) in a low-income and middle-income country population: the Microlife 3AS1-2.

OBJECTIVES: To assess the accuracy of the Microlife 3AS1-2 blood pressure device in pregnancy and pre-eclampsia in a low-resource setting. METHODS: Prospective validation according to the British Hypertension Society protocol. A total of 45 pregnant women were recruited from Kimberley Hospital (South Africa), of whom 15 had pre-eclampsia. RESULTS: The Microlife 3AS1-2 device achieved an overall B/A grade in pregnancy (including pre-eclampsia), passing the British Hypertension Society protocol requirements and achieving the International Organization for Standardization standard with a mean difference and SD of -3.8 ± 7.3 and -1.5 ± 6.2 mmHg for systolic and diastolic pressures, respectively. CONCLUSION: The Microlife 3AS1-2 device can be recommended for use in pregnancy, including pre-eclampsia. In addition, it fulfils the requirements stipulated by the WHO for an automated blood pressure device suitable for use in a low-resource setting. This makes it the ideal device for antenatal clinics and primary healthcare facilities in low-income and middle-income countries.

Validation of the Tensoval Duo Control II blood pressure monitor for clinic use and self-measurement according to the British Hypertension Society protocol and the European Society of Hypertension International Protocol Revision 2010.

OBJECTIVE: The Tensoval Duo Control II is an automated upper arm device that uses a combination of oscillometric and auscultatory technology to determine blood pressure noninvasively. The accuracy of this device was assessed according to the British Hypertension Society (BHS) protocol and the European Society of Hypertension International Protocol revision 2010 (ESH-IP2) in an adult population. METHODS: Ethical approval was obtained. Eighty-five and 33 adult individuals, respectively, were recruited to fulfil the requirements of each protocol. Trained observers took nine sequential same-arm measurements alternating between a mercury sphygmomanometer and the device. The device had to achieve at least a B grade for both systolic and diastolic pressures to pass the BHS protocol and had to fulfil the criteria of all three phases of the ESH-IP2 protocol to receive recommendation. RESULTS: The device achieved an A/A grading for the BHS protocol and passed all three phases of the ESH-IP2 protocol. The mean difference±SD for the BHS/ESH protocols, respectively, was -1.8±6.5/-0.7±5.7 mmHg for systolic pressure and 1.9±5.1/2.4±4.5 mmHg for diastolic pressure. The device maintained its A/A grading throughout the low-pressure, medium-pressure and high-pressure ranges. CONCLUSION: The Tensoval Duo Control II device is recommended for clinical and home use according to both the BHS and the ESH-IP2 standard.

Introduction of automated blood pressure devices intended for a low resource setting in rural Tanzania.

Regular blood pressure (BP) monitoring is a cost-effective means of early identification and management of hypertensive disease in pregnancy. In much of rural sub-Saharan Africa, the ability to take and act on accurate BP measurements is lacking as a result of poorly functioning or absent equipment and/or inadequate staff education. This study describes the feasibility of using validated automated BP devices suitable for low-resource settings (LRS) in primary health-care facilities in rural Tanzania. Following a primary survey, 19 BP devices were distributed to 11 clinics and re-assessed at one, three, six, 12 and 36 months. Devices were used frequently with high levels of user satisfaction and good durability. We conclude that the use of automated BP devices in LRS is feasible and sustainable. An assessment of their ability to reduce maternal and perinatal morbidity and mortality is vital.

Accuracy assessment of a novel blood pressure measurement device in a South African adult population: Tensoval duo control.

OBJECTIVE: The Tensoval duo control device uses a novel combination of auscultatory and oscillometric technology to measure blood pressure. We assessed the accuracy of this device in a South African adult population according to the International Protocol of the European Society of Hypertension. METHODS: Ethical approval was obtained and 33 participants were recruited from Kimberley Hospital Complex (South Africa). Trained observers took sequential same arm blood pressure measurements from each participant, alternating between mercury sphygmomanometery and the device. RESULTS: The Tensoval duo control passed all the phases of the protocol and achieved a mean difference ± SD of -3.2 ± 7.2 and 2.0 ± 6.0 mmHg for systolic and diastolic pressures, respectively. CONCLUSION: This study confirms the accuracy and recommendation for clinical use of the Tensoval duo control device in adults. Accuracy in special patient groups is yet to be assessed, but this novel technology could be particularly valuable in those with vascular disease.

The value of combined cervical length measurement and fetal fibronectin testing to predict spontaneous preterm birth in asymptomatic high-risk women.

OBJECTIVES: To determine the value of the combined use of fetal fibronectin (fFN) testing and transvaginal ultrasound measurement of cervical length (CL) for prediction of preterm birth (PTB) in asymptomatic high-risk women. METHODS: One hundred and forty-seven asymptomatic women at high-risk of PTB were referred to specialist antenatal clinics and underwent CL and fFN testing over a 12-month period. Women had both tests undertaken between 22(+0) and 30(+0) weeks' gestation, on one or more occasions. RESULTS: In those who labored spontaneously (n = 132), positive fFN and CL ≤ 25 mm was associated with a 53% risk of PTB at  < 37(+0) weeks' gestation, compared to a 10% risk in those with a negative fFN and CL  >  25 mm. With a known CL, the addition of positive fFN yielded significant hazard ratios regardless of CL (CL  >  25 mm-HR 2.78, CL  ≤ 25 mm-HR 3.14, p < 0.05). The hazard ratios were insignificant when CL results were added to a known fFN. CONCLUSIONS: In high-risk asymptomatic women, fFN may be used as a primary screening tool with CL measurement being reserved for those with a positive fFN result. Further prospective studies are needed to confirm our findings.

Accuracy assessment of the Dinamap ProCare 400 in pregnancy and preeclampsia.

OBJECTIVE: To assess the accuracy of the Dinamap ProCare 400 in pregnancy and preeclampsia, according to the British Hypertension Society protocol. METHODS: Ethical approval was obtained. Forty-five women were recruited at two large teaching hospitals. Nine sequential same arm measurements were taken from each woman alternating between the Dinamap and mercury sphygmomanometry. RESULTS: The device achieved an A/A grade (pregnancy) and an A/B grade (preeclampsia). Mean difference (SD) were 1.1(5.8)/0.1(5.7) mmHg (pregnancy) and -0.5(5.4)/0.9(9.5) mmHg (preeclampsia) for systolic/diastolic. CONCLUSION: The Dinamap ProCare 400 is recommended for use in pregnancy and has good accuracy in preeclampsia, although caution is still advised.

Does fetal fibronectin testing change patient management in women at risk of preterm labour?

OBJECTIVE: To determine clinicians' indications for, and actions following, fetal fibronectin testing in both symptomatic and asymptomatic women between 23(+0) and 34(+6) weeks' gestation. STUDY DESIGN: Following clinician education of the predictive ability of fetal fibronectin testing, results of all fetal fibronectin tests done at St Thomas' Hospital over a 6-week period were analysed. Clinicians were asked if the result changed management and if a reciprocal result would have altered management. RESULTS: Ninety-seven fetal fibronectin tests were conducted of which 21 (22%) were positive. Follow-up was done for 91 tests of which 25 (28%) test results directly changed management; 81 (89%) test results had the potential to change management independent of the test result. CONCLUSION: The results of fetal fibronectin testing directly influenced management in a significant number of patients. A large number of women were asymptomatic at testing. Fetal fibronectin testing could be offered more widely and has the potential to benefit patient management.

Validation of a non-mercury digital auscultatory device according to the European Hypertension Society protocol: Rossmax Mandaus II.

OBJECTIVE: To assess the accuracy of the Rossmax Mandaus II for clinical use, according to the protocol of the European Society of Hypertension (ESH). METHODS: Thirty-nine participants were recruited to fulfill the 33 participant requirement of the protocol. Nine sequential same-arm blood pressure readings were taken by trained observers alternating between simultaneous mercury sphygmomanometer readings and the device readings. The latter seven readings were analysed according to the protocol guidelines and the criteria of the Association for the Advancement of Medical Instrumentation. RESULTS: The device passed both phases of the ESH protocol. Out of 99 differences, 78 systolic (SBP) and 84 diastolic (DBP) differences were within 5 mmHg; all differences were within 10 and 15 mmHg for both SBP and DBP. In phase 2.2 for SBP and DBP, respectively, 28 of 33 and 31 of 33 participants had at least two out of their three differences within 5 mmHg. Only one participant was found to have all three differences greater than 5 mmHg for SBP and DBP, respectively. The device also fulfilled the criteria of the Association for the Advancement of Medical Instrumentation standard with a mean difference+/-SD of -2.5+/-3.4 mmHg (SBP) and -2.3+/-3.6 mmHg (DBP). CONCLUSION: The Rossmax Mandaus II is the first auscultatory device with a numeric digital display to pass the ESH protocol. It can be recommended for clinical use in an adult population.

Validation of the Nissei DS-400 in a low-resource setting.

OBJECTIVE: Hypertension affects approximately one billion individuals worldwide. The effective management of hypertension requires accurate measurement and monitoring of blood pressure. We evaluated the accuracy of a low cost self-measurement oscillometric device, with features suitable for use in a low-resource setting, in an adult population in the developing world according to the International Protocol of the European Society of Hypertension. METHODS: Trained observers using a double-headed stethoscope took nine sequential same arm measurements from 33 participants, alternating between mercury sphygmomanometry and the test device. Anyone with an arrhythmia or unclear Korotkoff sounds was excluded. Data were analyzed according to the protocol guidelines. RESULTS: The device passed all the criteria of the International Protocol with 78/95/99 and 80/95/99 of systolic and diastolic differences, respectively, within 5/10/15 mmHg of the mercury standard. It also achieved the Association for the Advancement of Medical Instrumentation criteria with a mean difference (standard deviation) of 0.8 (4.4) mmHg and -0.9 (4.5) mmHg for systolic blood pressure and diastolic blood pressure, respectively. CONCLUSION: The Nissei DS-400 can be recommended for use in the adult population, particularly in the developing world. Its impressive performance may be related to theoretical factors within the patient population and environment (e.g. temperature, humidity and altitude) that could influence the device's performance.

Validation and compliance of a home monitoring device in pregnancy: microlife WatchBP home.

OBJECTIVE: To assess the accuracy and patient compliance in using a novel home blood pressure monitoring device in high-risk pregnancy. METHODS: Device accuracy was assessed according to the British Hypertension Society protocol in 45 pregnant women, including 15 with preeclampsia. Twenty-one high-risk pregnant women used the device in addition to their antenatal care. RESULTS: The device achieved a mean difference +/- SD of 0.4 +/- 7.3/-0.4 +/- 5.5 mmHg (pregnancy) and -2.6 +/- 7.0/0.8 +/- 4.4 mmHg (preeclampsia) for systolic/diastolic pressure. Eighty-one percent of women did at least 6 measurements/day and all women did at least 2 measurements/week. CONCLUSION: The Microlife WatchBP Home is accurate for use in pregnancy and increases surveillance in compliant patients.

Accuracy of inflationary versus deflationary oscillometry in pregnancy and preeclampsia: OMRON-MIT versus OMRON-M7.

OBJECTIVE: To assess the accuracy of the OMRON-MIT (inflationary) and OMRON-M7 (deflationary) devices for measuring blood pressure in a pregnant population, including women with preeclampsia, according to the British Hypertension Society protocol. METHODS: Forty-five pregnant women, including 15 with preeclampsia, were recruited at a large teaching hospital. Nine sequential same arm measurements were taken from each patient alternating between the test device and mercury sphygmomanometry. Both devices were assessed in the same women. Data were analysed according to the British Hypertension Society protocol. RESULTS: The OMRON-MIT achieved an A/A grade in both pregnancy and preeclampsia with an overall mean difference (SD) of -1.3 (5.6) mmHg and 0.4 (5.6) mmHg for systolic and diastolic pressures, respectively. The OMRON-M7 achieved an A/A grade in pregnancy and a B/B grade in preeclampsia with an overall mean difference (SD) of -5.3 (6.6) mmHg and -3.5 (6.9) mmHg. CONCLUSION: Both the OMRON-MIT and the OMRON-M7 can be recommended for use in pregnancy and preeclampsia. Inflationary oscillometry (OMRON-MIT) was more accurate in preeclampsia.