Blood pressure thresholds in pregnancy for identifying maternal and infant risk: a secondary analysis of Community-Level Interventions for Pre-eclampsia (CLIP) trial data.

Background: Blood pressure measurement is a marker of antenatal care quality. In well resourced settings, lower blood pressure cutoffs for hypertension are associated with adverse pregnancy outcomes. We aimed to study the associations between blood pressure thresholds and adverse outcomes and the diagnostic test properties of these blood pressure cutoffs in low-resource settings.

The ability and safety of community-based health workers to safely initiate lifesaving therapies for pre-eclampsia in Ogun State, Nigeria: An analysis of 260 community treatments with MgSO and/or methyldopa.

Objectives: To evaluate community-based health workers' ability to identify cases of hypertension in pregnancy, safely deliver methyldopa and magnesium sulphate and make referrals when appropriate.

Study Design: This was part of Nigeria Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomized controlled trial (NCT01911494). Community-based Health Workers (CHW) recruited pregnant women from five Local Government Areas (clusters) and used mobile health aid for clinical assessment of pre-eclampsia.

Effect of the CRADLE vital signs alert device intervention on referrals for obstetric haemorrhage in low-middle income countries: a secondary analysis of a stepped- wedge cluster-randomised control trial.

Background: Obstetric haemorrhage is the leading cause of maternal death worldwide, 99% of which occur in low and middle income countries. The majority of deaths and adverse events are associated with delays in identifying compromise and escalating care. Management of severely compromised pregnant women may require transfer to tertiary centres for specialised treatment, therefore early recognition is vital for efficient management.

Pregnancy Outcomes and Blood Pressure Visit-to-Visit Variability and Level in Three Less-Developed Countries.

[Figure: see text].

Community-level interventions for pre-eclampsia (CLIP) in Pakistan: A cluster randomised controlled trial.

Objectives: To reduce all-cause maternal and perinatal mortality and major morbidity through Lady Health Worker (LHW)-facilitated community engagement and early diagnosis, stabilization and referral of women with preeclampsia, an important contributor to adverse maternal and perinatal outcomes given delays in early detection and initial management.

Study Design: In the Pakistan Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomized controlled trial (NCT01911494), LHWs engaged the community, recruited pregnant women from 20 union councils (clusters), undertook mobile health-guided clinical assessment for preeclampsia, and referral to facilities after stabilization.

Main Outcome Measures: The primary outcome was a composite of maternal, fetal and newborn mortality and major morbidity.

Setting and techniques for monitoring blood pressure during pregnancy.

Background: Regular blood pressure (BP) measurement is crucial for the diagnosis and management of hypertensive disorders in pregnancy, such as pre-eclampsia. BP can be measured in various settings, such as conventional clinics or self-measurement at home, and with different techniques, such as using auscultatory or automated BP devices. It is important to understand the impact of different settings and techniques of BP measurement on important outcomes for pregnant women.

Community level interventions for pre-eclampsia (CLIP) in India: A cluster randomised controlled trial.

Objectives: Pregnancy hypertension is associated with 7.1% of maternal deaths in India. The objective of this trial was to assess whether task-sharing care might reduce adverse pregnancy outcomes related to delays in triage, transport, and treatment.

Community-level interventions for pre-eclampsia (CLIP) in Mozambique: A cluster randomised controlled trial.

Objectives: Pregnancy hypertension is the third leading cause of maternal mortality in Mozambique and contributes significantly to fetal and neonatal mortality. The objective of this trial was to assess whether task-sharing care might reduce adverse pregnancy outcomes related to delays in triage, transport, and treatment.

Study Design: The Mozambique Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomised controlled trial (NCT01911494) recruited pregnant women in 12 administrative posts (clusters) in Maputo and Gaza Provinces.

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.

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.

The incidence of pregnancy hypertension in India, Pakistan, Mozambique, and Nigeria: A prospective population-level analysis.

Background: Most pregnancy hypertension estimates in less-developed countries are from cross-sectional hospital surveys and are considered overestimates. We estimated population-based rates by standardised methods in 27 intervention clusters of the Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomised trials.

Methods And Findings: CLIP-eligible pregnant women identified in their homes or local primary health centres (2013-2017).

Effect of a novel vital sign device on maternal mortality and morbidity in low-resource settings: a pragmatic, stepped-wedge, cluster-randomised controlled trial.

Background: In 2015, an estimated 303 000 women died in pregnancy and childbirth. Obstetric haemorrhage, sepsis, and hypertensive disorders of pregnancy account for more than 50% of maternal deaths worldwide. There are effective treatments for these pregnancy complications, but they require early detection by measurement of vital signs and timely administration to save lives.

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.

Innovations in vital signs measurement for the detection of hypertension and shock in pregnancy.

Approximately 820 women die in pregnancy and childbirth every day worldwide, with 99% of these occurring in low-resource settings. The most common causes of maternal mortality are haemorrhage, sepsis and hypertensive disorders. There are established, effective solutions to these complications, however challenges remain in identifying who is at greatest risk and ensuring that interventions are delivered early when they have the greatest potential to benefit.

Evaluation of a novel vital sign device to reduce maternal mortality and morbidity in low-resource settings: a mixed method feasibility study for the CRADLE-3 trial.

Background: The CRADLE-3 trial is a stepped-wedge randomised controlled trial aiming to reduce maternal mortality and morbidity by implementing a novel vital sign device (CRADLE Vital Sign Alert) and training package into routine maternity care in 10 low-income sites. The MRC Guidance on complex interventions proposes that interventions and implementation strategies be shaped by early phase piloting and development work. We present the findings of a three-month mixed-methodology feasibility study for this trial, describe how this was informed by the MRC guidance and the study design was refined.

Evaluation of a novel device for the management of high blood pressure and shock in pregnancy in low-resource settings: study protocol for a stepped-wedge cluster-randomised controlled trial (CRADLE-3 trial).

Background: Obstetric haemorrhage, sepsis and pregnancy hypertension account for more than 50% of maternal deaths worldwide. Early detection and effective management of these conditions relies on vital signs. The Microlife® CRADLE Vital Sign Alert (VSA) is an easy-to-use, accurate device that measures blood pressure and pulse.

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.

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.

Reverse innovation in maternal health.

Reverse innovation, defined as the flow of ideas from low- to high-income settings, is gaining traction in healthcare. With an increasing focus on value, investing in low-cost but effective and innovative solutions can be of mutual benefit to both high- and low-income countries. Reverse innovation has a role in addressing maternal health challenges in high-income countries by harnessing these innovative solutions for vulnerable populations especially in rural and remote regions.

Determination of Normal Ranges of Shock Index and Other Haemodynamic Variables in the Immediate Postpartum Period: A Cohort Study.

Objective: To determine the normal ranges of vital signs, including blood pressure (BP), mean arterial pressure (MAP), heart rate (HR) and shock index (SI) (HR/systolic BP), in the immediate postpartum period to inform the development of robust obstetric early warning scores.

Study Design: We conducted a secondary analysis of a prospective observational cohort study evaluating vital signs collected within one hour following delivery in women with estimated blood loss (EBL) <500ml (316 women) delivering at a UK tertiary centre over a one-year period. Simple and multiple linear regression were used to explore associations of demographic and obstetric factors with SI.

Vital Sign Prediction of Adverse Maternal Outcomes in Women with Hypovolemic Shock: The Role of Shock Index.

Objective: To determine the optimal vital sign predictor of adverse maternal outcomes in women with hypovolemic shock secondary to obstetric hemorrhage and to develop thresholds for referral/intensive monitoring and need for urgent intervention to inform a vital sign alert device for low-resource settings.

Study Design: We conducted secondary analyses of a dataset of pregnant/postpartum women with hypovolemic shock in low-resource settings (n = 958). Using receiver-operating curve analysis, we evaluated the predictive ability of pulse, systolic blood pressure, diastolic blood pressure, shock index, mean arterial pressure, and pulse pressure for three adverse maternal outcomes: (1) death, (2) severe maternal outcome (death or severe end organ dysfunction morbidity); and (3) a combined severe maternal and critical interventions outcome comprising death, severe end organ dysfunction morbidity, intensive care admission, blood transfusion ≥ 5 units, or emergency hysterectomy.

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.

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.

Diagnosis and management of a ruptured rudimentary horn pregnancy in a low-resource setting.

A 22-year-old woman presented with amenorrhoea, lower abdominal pain and brown vaginal discharge. She was noted to be in hypovolaemic shock with a distended and peritonitic abdomen. On bimanual examination, the uterus was not palpated, the posterior fornix was full and cervical excitation was present.