OBJECTIVE:To evaluate the impact of a change in national guidance on the management of hypoglycaemia on UK term neonatal unit (NNU) admissions, describe perinatal risk factors for hypoglycaemia and identify opportunities to reduce term infant hypoglycaemia admissions. DESIGN:Retrospective observational cohort study, the UK National Neonatal Research Database. PATIENTS:Term infant NNU admissions in England and Wales, 2012-2020. MAIN OUTCOME MEASURES:Term admission rate to NNU primarily for hypoglycaemia/1000 term live births. Change between epoch 1 (36 months before the publication of the British Association of Perinatal Medicine (BAPM) Framework in April 2017) and epoch 2 (36 months after the publication of the BAPM Framework in April 2017). RESULTS:Term admissions primarily for hypoglycaemia decreased from 4.9 (95% CI 4.8 to 5.1) to 3.3 (95% CI 3.1 to 3.4) admissions/1000 term live births; proportion of potentially avoidable hypoglycaemia admissions (enteral feeds and special care only) decreased (from 12.8% (95% CI 12.1% to 13.4%) to 8.9% (95% CI 8.3% to 9.5%)), time to NNU admission and median length of stay were unchanged between epoch 1 and epoch 2. 46.5% (11 825/25 406) of infants admitted primarily for hypoglycaemia had one or more BAPM hypoglycaemia risk factors. Of infants with hypoglycaemia without BAPM risk factors, 44% (5990/13 581) had a birth weight above the 90th centile or between the 2nd centile and the 9.9th centile. CONCLUSIONS:The publication of a national framework for term hypoglycaemia management was associated with a reduction in term NNU admission rates without delays in admission time or increased length of stay. One in two infants admitted for hypoglycaemia had no BAPM risk factors. Future research should explore birth weight between the 2nd centile and the 9.9th centile and above the 90th centile as additional factors that may further enhance hypoglycaemia risk stratification.
Background: APOL1 risk alleles are prevalent in individuals of West African ancestry and associated with increased risk of kidney disease. Although preeclampsia disproportionately affects women of Black ethnic backgrounds, evidence linking APOL1 alleles to preeclampsia remains conflicting. Objectives: The purpose of this study was to explore whether maternal APOL1 alleles contribute to preeclampsia risk and associated adverse pregnancy outcomes. Study design: We conducted a nested case-control study of 5210 pregnant women, including 745 preeclampsia cases and 949 controls of Black self-reported ethnicity, 1385 preeclampsia cases and 2131 controls of White self-reported ethnicity. APOL1 G1 and G2 risk alleles were directly genotyped on the Illumina Infinium Global Screening Array. Associations with preeclampsia, early preeclampsia, recurrent preeclampsia, birthweight centiles and gestational age at delivery were examined using regression models assuming a recessive mode of inheritance with adjustment for established risk factors and stratification by self-reported ethnicity and genetically-determined ancestry. Results: Presence of APOL1 risk alleles was almost exclusively observed in women of Black self-reported ethnicity. 168/949 controls (17.7%) and 133/745 cases (17.9%) carried two APOL1 risk alleles, and these women did not have a significantly increased risk of preeclampsia compared to those with zero or one APOL1 risk alleles in adjusted analyses (OR 1.00, 95% CI 0.76-1.29, p=0.972). When restricting analysis to women of Black self-reported ethnicity only, no association was observed between APOL1 genotype and preeclampsia risk (adjusted OR 0.94, 95% CI 0.61-1.25, p=0.673). When restricting analysis to women of pan-African genetically-determined ancestry only, also no association was observed between APOL1 genotype and preeclampsia risk (adjusted OR 1.00, 95% CI 0.76-1.32). No associations were found between number of APOL1 risk alleles and early preeclampsia, recurrent preeclampsia, birthweight centile or gestational age at delivery after adjustment for established risk factors and stratification by self-reported ethnicity or genetically-determined ancestry. Conclusions: Maternal APOL1 risk alleles do not independently influence preeclampsia risk or related adverse outcomes in a multi-ethnic pregnancy study. Future studies should examine whether fetal APOL1 genotypes, alone or in interaction with maternal genotypes, contribute to preeclampsia risk. ### Competing Interest Statement FCR receives part-time salary contribution as Chief Medical Officer at MEGI Health UK Ltd and receives consulting fees for advisory services provided through Option 5 Health Limited, Revena Limited and Gerson Lehrman Group Limited (GLG). The remaining authors have nothing to disclose. ### Funding Statement This study was supported by a grant from the Fetal Medicine Foundation. FCR is supported by the Medical Research Council (MR/V006835/1). LCC is supported by an NIHR Senior Investigator Award. PH is supported by BrightFocus, US (G2021011S) and US NIH (R21AI177219). AdM is supported by the Fetal Medicine Foundation (495237). ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: This study was approved by the NHS Research Ethics Committee (REC reference: 02-03-033) on 11th March 2003. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors
BACKGROUND:For many women who experience hypertension in pregnancy, raised blood pressure continues into the postpartum period, usually settling over the first 6-12 weeks. Blood pressure control during this time appears to be important for long-term cardiovascular health but care appears to be haphazard. This study aimed to understand UK National Health Service usual postpartum care for such women. METHODS:A cross-sectional online survey was designed and piloted by a multidisciplinary team of midwives, obstetricians, primary care researchers, patient representatives, and a general practitioner, to capture current practice including blood pressure monitoring, antihypertensive prescribing, and use of self-monitoring; there were 38 questions. The survey was delivered via the Doctors.net (for obstetricians and general practitioners) and Joint Information Systems Committee (JISC) online platforms (for Midwives) from May to November 2023. RESULTS:A total of 253 clinicians responded to the survey, including 101 General Practitioners, 100 doctors working in maternity care, trained in obstetrics (obstetricians) or with specialist expertise in medical disorders in pregnancy (obstetric physicians), 50 midwives, and 2 maternity support workers. Women's care generally transferred from secondary to primary care at around two weeks postpartum, although this was not consistent, and there were differences in practice, awareness, and expectations between professions around the management of hypertension and responsibility. Communication barriers between professional groups and a need for better guidance and co-ordination were highlighted, and most professionals agreed that self-measured blood pressure readings could support postpartum care for those with hypertension. CONCLUSIONS:The survey highlighted variations in the practice and expectations of different healthcare professionals involved in postpartum care. The time when care was transferred from hospital to primary care was not consistent, with potential for women's care to fall through gaps. The transfer of information and women's ability to access care at this time were highlighted as problematic.
OBJECTIVES:Hypertensive disorders of pregnancy (HDP), including preeclampsia, pose lifelong health risks for women and infants. Although HDP interventions are increasingly evaluated for cost-effectiveness, methodological challenges and heterogeneity between studies exist. This systematic review examines how economic evaluations have been conducted, focusing on methodology, outcome measurement, perspectives, time horizons, and cost-effectiveness conclusions. METHODS:Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 guidelines, we searched MEDLINE, Embase, EconLit, and Web of Science from inception to December 31, 2024 for cost-effectiveness, cost-utility, cost-benefit, cost-consequence, and cost-minimization analyses of HDP interventions. Searching was updated on November 4, 2025. Data on costs, outcomes, and methodology were extracted. Reporting quality was evaluated using Consolidated Health Economic Evaluation Reporting Standards 2022. RESULTS:Thirty-five included studies covered interventions from prevention to management. One-third of cost-effectiveness and cost-utility studies reported only women's outcomes. Among those capturing maternal and infant outcomes, more than half estimated cost-effectiveness using outcomes for only 1 party. The remainder generated results for mothers and infants but using different approaches. Long-term maternal cardiovascular risks and infant outcomes were rarely extrapolated. Most studies adopted healthcare perspectives. Screening, prevention, and diagnostic interventions were frequently cost-effective, whereas evidence for treatment and management strategies was mixed. Most studies reported cost per preeclampsia case averted; fewer applied generic measures, limiting comparability. CONCLUSIONS:Economic evaluations of HDP interventions face methodological challenges, particularly in capturing joint maternal and infant impacts. Furthermore, future studies should use adequate time horizons, wider perspectives, and generic health outcomes to ensure that cost-effectiveness evidence captures the full value of HDP interventions and informs policies optimizing maternal and neonatal health.
Hypertensive disorders of pregnancy, experienced by around 10% of women, are among the most severe health problems affecting people during and following pregnancy. Symptoms can persist in the weeks and months following birth, with potential to impact longer-term health. Postnatal care has long been recognised as a critical period for mother and baby, and emerging evidence suggests it is a window of opportunity for cardiac remodelling after a hypertensive pregnancy. But provision is often not fit for purpose and haphazard. To understand what care women receive, how it gets done, and additional barriers for minority or socially deprived groups, we undertook interviews and focus groups with 44 women with a recent hypertensive pregnancy and interviews with 36 health professionals providing postnatal care in National Health Service (NHS) maternity care, primary care and community services in England. Analysis revealed that, despite the first six weeks being an important period for managing blood pressure, women often fall through the cracks between secondary and primary care. Invisible to these siloed clinical specialities, women are faced with new self-management and surveillance responsibilities alongside the work of new motherhood. Analysis, informed by Meleis’s transitions theory and Gidden’s concept of ‘distanciation’, develops Scott’s ‘sociology of nothing’ to explore responsibilities and consequences of being ‘unseen’ between services.
Background Pregnancy-associated acute kidney injury (PrAKI) is a major contributor to maternal and perinatal morbidity and mortality in low-and middle-income countries, where detection is often delayed due to limited access to creatinine testing. Point-of-care creatinine (POC-Cr) devices may offer a practical alternative. We aimed to describe the incidence, resolution, and clinical consequences of presumed PrAKI or kidney dysfunction among high-risk pregnant and postpartum women, and to assess feasibility of POC-Cr testing. Methods We conducted a study of pregnant or postpartum women at high risk of PrAKI at a hospital in Freetown, Sierra Leone (April–August 2023). Eligibility criteria were systolic blood pressure ≥140 mmHg, diastolic ≥90 mmHg, and/or shock index ≥0.9. Women underwent POC-Cr testing at enrolment and 24 and 48 h. PrAKI was defined as POC-Cr >77 μmol/L, or a change ≥26 μmol/L, and staged where possible. Associations with maternal and perinatal outcomes were assessed. Multivariable logistic regression identified risk factors. Feasibility was evaluated by refusal and test failure. Findings Of 1746 eligible women, 1669 (96%) were tested; two declined and one failed. PrAKI or chronic kidney disease occurred in 427 (25.6%). Affected women had maternal (15.4%, 66/427 versus 8.7%, 108/1239) and perinatal (19.3%, 23/119 versus 4.8%, 20/413) adverse outcomes (p < 0.0001). At discharge, 47%, 202/427 had unresolved kidney injury or underlying disease. Independent risk factors included age, mean arterial pressure, and pre-eclampsia or eclampsia. Interpretation Kidney dysfunction complicates a quarter of pregnancies and is associated with adverse outcomes. POC-Cr testing may enable earlier detection and improved care in resource-limited settings. Funding This study was funded by the UK Medical Research Council (MR/T038594/1) and the National Institute for Health and Care Research (NIHR133232).
Hypertensive disorders of pregnancy affect around 10
The aim was to evaluate health resource use and cost, and conduct a cost comparison of repeat placental growth factor (PlGF)-based testing for suspected pre-eclampsia, compared with usual care. This was a health economic evaluation in women participating in the PARROT-2 trial of repeat revealed PlGF-based testing, compared to usual care, for suspected preterm pre-eclampsia in 22 maternity units in England, Scotland, and Wales, (ISRCTN85912420, 25/11/2019). We conducted a cost comparison analysis, describing health resource use and associated cost per woman, infant, and mother–infant dyad according to randomised allocation to repeat revealed PlGF-based testing or usual care with repeat concealed testing. Additional analysis was stratified according to the initial PlGF-based test result (normal, abnormal, or very abnormal). A post-hoc, within-trial cost-effectiveness analysis was also conducted. Between December 17, 2019, and September 30, 2022, 1253 participants were randomised. Costs per woman, infant, or mother–infant dyad were similar between the repeat revealed testing group and the group receiving usual care with repeat concealed testing. In the revealed group compared to the usual care group, there were significantly greater costs associated with neonatal admissions for special care (mean difference £1169 95
Background Raised blood pressure affects 10% of pregnancies worldwide, of which around half develop pre-eclampsia including proteinuria, causing maternal and perinatal morbidity and mortality. Objectives To develop and test interventions for self-monitoring of blood pressure designed to improve the detection and management of hypertension in pregnancy. Additionally, to test the accuracy of self-testing of urine for protein, a key marker of pre-eclampsia. Design and methods Development phase, a pilot trial, two large randomised controlled trials of self-monitoring of blood pressure interventions with integrated economic evaluations, linked qualitative work, a large survey and a diagnostic accuracy study of self-testing for proteinuria, and finally economic modelling. Setting and participants Antenatal clinics in 16 English hospitals. Participants were pregnant women and antenatal healthcare professionals. Patient and public involvement Comprehensive involvement from initial development through to dissemination, with collaboration from both individuals and relevant charities and organisations. Interventions Self-monitoring of blood pressure supported by app to improve the detection (BUMP1) and management (BUMP2) of raised blood pressure in pregnancy (WS3.2.1 and 2). Proteinuria self-testing by pregnant hypertensive women (UDIP, WS4). Main outcome measures Qualitative data informed the development of the BUMP App and trial (WS1). Feasibility of self-monitoring of blood pressure in hypertensive pregnancy (recruitment, retention, adherence and intervention persistence) (WS2). Prevalence of self-monitoring of blood pressure during pregnancy (WS3.1). Time to diagnosis of hypertension defined in routinely recorded clinical data (BUMP1, WS3.2.1) and difference in mean systolic blood pressure recorded by healthcare professionals between randomisation and birth (BUMP2, WS3.2.2). WS3.3 and 4.2 evaluated experiences with the trial and UDIP respectively using inductive and deductive thematic analysis. Within-trial cost–consequence analysis and long-term cost-effectiveness modelling (WS3.4 and WS5). Proteinuria testing accuracy (WS4.1). Results WS1: Areas important to staff included providing clear patient information and supporting them in decision-making in the context of discrepant readings. The intervention was optimised iteratively with pregnant women. WS2: A feasibility trial showed that the self-monitoring of blood pressure intervention was feasible and acceptable. WS3.1: Data from a survey of 5181 women showed that 19% of pregnant women were currently self-monitoring blood pressure but only 482/983 (49%) shared this information with healthcare professionals. WS3.2.1: Self-monitoring of blood pressure in addition to usual care did not lead to an earlier diagnosis of clinic hypertension in routinely recorded clinical data with no evidence of differences in maternal or perinatal outcomes or serious adverse events (BUMP1). WS3.2.2: Self-monitoring of blood pressure in pregnancy hypertension did not improve clinic blood pressure control, with no difference in maternal or perinatal outcomes or serious adverse events (BUMP2). WS3.3: Self-monitoring was generally accepted by women and professionals with differences in views of which blood pressure data to give precedence. Women found self-monitoring empowering, provided health professionals considered home readings in their management. On occasion self-monitoring proved unsettling due to uncertainty. WS3.4: Within trial economic analyses revealed no significant difference in overall total costs between trial arms in either BUMP1 or BUMP2. Women’s health-related quality of life (EQ-5D-5L) was similar between groups in both trials. WS4: Self-testing for proteinuria had a sensitivity of 0.71 (95% confidence interval 0.62 to 0.79) and a specificity of 0.89 (95% confidence interval 0.84 to 0.92) compared to laboratory protein–creatinine ratio testing and this was not clinically or statistically different when compared to healthcare professionals or a colorimetric monitor (UDIP, WS4.1). Self-testing was generally acceptable (WS4.2). WS5: Model frameworks capable of facilitating exploration of the long-term cost-effectiveness of combining self-monitoring of blood pressure with blood pressure treatment and management policies were developed for use in future research projects in the area. Implementation: Self-monitoring was rapidly and widely implemented during the pandemic but has yet to become fully embedded in clinical pathways. Limitations Self-monitoring of blood pressure by women in the control groups; difficulties in testing self-monitoring of blood pressure in clinical pathways in the absence of evidence or accepted treatment thresholds; process evaluation suggested women and professionals privileged different information. Conclusions Self-monitoring of blood pressure during higher risk or hypertensive pregnancy was feasible, acceptable, safe, and no more expensive, but did not improve the detection of hypertension or blood pressure control in those with hypertension when used alongside usual care. During the programme, self-monitoring of blood pressure entered common practice in pregnancy, a process accelerated by the pandemic. Pregnant women can read a dipstick for urinary protein with similar accuracy to healthcare professionals or colorimetric testing, and find this acceptable, suggesting that self-testing could be included in clinical pathways. Future work Future trials of interventions including self-monitoring of blood pressure should test strategies in the context of novel clinical pathways. Study registration This study is registered as Current Controlled Trials ISRCTN16018898. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme (NIHR award ref.: RP-PG-0614-20005) and is published in full in Programme Grants for Applied Research; Vol. 14, No. 3. See the NIHR Funding and Awards website for further award information. Plain language summary Background and aims Home monitoring of blood pressure supports the management of raised blood pressure (hypertension) in the general population, but little was known about its use in pregnancy. Similarly, little was known regarding self-testing for protein in the urine, a marker of pre-eclampsia which is a serious condition linked to hypertension in pregnancy. The BUMP programme aimed to develop and test blood pressure home monitoring and protein self-testing to see if these could improve the detection of raised blood pressure and/or proteinuria and management of hypertension in pregnancy. Findings Focus groups and interviews with healthcare professionals and development work (designing the intervention) with pregnant women supported the development of a user-friendly app, trial design and materials. A survey identified that one in five of pregnant women currently home monitor blood pressure, increasing to half of those with hypertension, though did not share these readings with healthcare professionals. The BUMP trials recruited more than 3000 women at higher risk of pre-eclampsia, or those with raised blood pressure. Participating women were randomly allocated to either usual care or usual care plus self-monitoring of blood pressure. Home monitoring of blood pressure did not result in earlier recording of hypertension in clinic. Over half of the women diagnosed with hypertension had raised blood pressure at home. For women with high blood pressure, home monitoring did not improve blood pressure control. Home monitoring of blood pressure was safe and engagement was high, with the majority of women continuing home monitoring throughout pregnancy. No differences in costs or quality of life were found. Pregnant women self-tested for urinary protein with similar accuracy to healthcare professionals and were happy to test finding it, convenient and reassuring. Staff found home readings valuable, although some were less willing to incorporate them into antenatal care. Conclusions Home monitoring of blood pressure during higher risk or hypertensive pregnancy was acceptable, safe, and no more expensive than usual care alone but it did not improve the detection of hypertension or blood pressure control in those with hypertension when used alongside usual care. Self-testing of urine for protein could support remote care of hypertensive women. Scientific summary Background Raised blood pressure (BP) affects 10% of pregnancies worldwide, of which around half develop pre-eclampsia, a leading cause of maternal and perinatal morbidity and mortality. Early detection of raised BP and/or proteinuria and subsequent management of pregnancy hypertension is therefore important and could be improved through self-monitoring whilst empowering women and allowing reduced antenatal visits. However, little evidence was available to guide the utilisation of self-monitoring in pregnancy. Objectives The overall aim of this programme was to evaluate whether self-monitoring of BP (SMBP) could improve the detection of raised BP during pregnancy, whether it was feasible for use in the titration of antihypertensive medication in pregnancy hypertension and whether women with raised BP in pregnancy could accurately test their urine for proteinuria, a key marker for pre-eclampsia. Linked qualitative and economic components examined patient and professional experiences of self-monitoring and responses to it along with cost-effectiveness within the trial and in the longer term. Key research questions WS1: Development What are the best self-monitoring interventions to use? How can SMBP and urine best integrate into current antenatal care pathways? WS2: Blood pressure self-monitoring during pregnancy for anti-hypertensive titration Is titration of antihypertensive medication during and after pregnancy using self-monitoring feasible? What is the participant and professional experience of such monitoring and titration? WS3: Self-monitoring to improve the detection and management of raised blood pressure in pregnancy What is current practice in BP self-monitoring in pregnancy? Can BP self-monitoring improve the detection and management of hypertension during pregnancy? How is BP self-monitoring in pregnancy implemented in daily life and routine clinical practice? Is BP self-monitoring in pregnancy cost-effective? WS4: Self-monitoring of urinary protein in hypertensive pregnancy Can pregnant women with hypertension accurately self-monitor for proteinuria and could this detect pre-eclampsia earlier than usual care? Is self-monitoring of urine practical and acceptable to hypertensive pregnant women, their midwives and obstetricians? WS5: Modelling of the potential long-term costs and consequences Is SMBP and protein in hypertensive pregnancy potentially cost-effective and what are the key parameters affecting this? Methods WS1: Development Focus groups and interviews were undertaken with NHS staff (including obstetricians, community and hospital midwives). We worked iteratively with women talking through their experiences of prototypes of the self-monitoring app and trial materials (Band R, Hinton L, Tucker KL, Chappell LC, Crawford C, Franssen M, et al. Intervention planning and modification of the BUMP intervention: a digital intervention for the early detection of raised blood pressure in pregnancy. Pilot Feasibility Stud 2019;5:153. https://doi.org/10.1186/s40814-019-0537-z; Hinton L, Hodgkinson J, Tucker KL, Rozmovits L, Chappell L, Greenfield S, et al. Exploring the potential for introducing home monitoring of blood pressure during pregnancy into maternity care: current views and experiences of staff – a qualitative study. BMJ Open 2020;10:e037874. https://doi.org/10.1136/bmjopen-2020-037874). WS2: Blood pressure self-monitoring during pregnancy for antihypertensive titration The OPTIMUM feasibility trial It was an unmasked randomised controlled trial (RCT) comparing a SMBP versus usual care for the management of pregnancy hypertension. Women with chronic (CH) or gestational hypertension (GH) from four UK centres were randomised (2 : 1) intervention to control. Primary outcomes were recruitment, retention, adherence and persistence with the intervention (Pealing LM, Tucker KL, Mackillop LH, Crawford C, Wilson H, Nickless A, et al.; OPTIMUM-BP Investigators. A randomised controlled trial of blood pressure self-monitoring in the management of hypertensive pregnancy. OPTIMUM-BP: a feasibility trial. Pregnancy Hypertens 2019;18:141–9. https://doi.org/10.1016/j.preghy.2019.09.018). WS3: Self-monitoring to improve the detection and management of raised blood pressure in pregnancy 3.1 BUMP survey Pregnant women from antenatal clinics in 16 hospitals in England were invited to complete a survey about SMBP. 3.2.1 The BUMP1 trial (Dougall G, Franssen M, Tucker KL, Yu L-M, Hinton L, Rivero-Arias O, et al. Blood pressure monitoring in high-risk pregnancy to improve the detection and monitoring of hypertension (the BUMP 1 and 2 trials): protocol for two linked randomised controlled trials. BMJ Open 2020;10:e034593. https://doi.org/10.1136/bmjopen-2019-034593) It was a multicentre, RCT that recruited pregnant women at higher risk of pre-eclampsia at 20 weeks’ gestation. Women were randomised to BP self-monitoring with telemonitoring and usual care or to usual care alone. The primary outcome was time to the first recorded raised BP taken by a healthcare professional (HCP). Trial registration: NCT03334149. Recruitment 2018–9. Final follow-up April 2020. 3.2.2 The BUMP2 trial It was a multicentre, RCT that recruited women with CH and GH up to 37 weeks’ gestation. Women were randomised to BP self-monitoring with telemonitoring and usual care or to usual care alone. The primary maternal outcome was the difference in mean systolic BP recorded by HCPs between study entry and childbirth. Analyses were by intention to treat (ITT) and stratified by CH or GH. Trial registration: NCT03334149. Recruitment 2018–19. Final follow-up May 2020. 3.3 BUMP trials qualitative process evaluation In-depth interviews were carried out with 39 trial participants and 7 women who declined to take part in the trials to explore their experiences of self-monitoring BP or reasons for choosing not to. Twenty-one HCPs involved in women’s care or in the administration of the trial were interviewed. Interviews were purposively sampled from study sites. A planned ethnographic study was not feasible. Inductive and deductive thematic analysis was carried out on both qualitative data sets. Interviews were analysed using a coding frame that was developed from the research aims and incorporating additional themes that emerged from the data. 3.4 BUMP within-trial economic analyses National Health Service (NHS) perspectives were used for both within trial cost–consequences analyses. Patient-level resource use data were extracted from clinical notes and costed and women’s health-related quality of life was measured during the trials using the EuroQol EQ-5D-5L questionnaire, with responses converted to single index scores. Mean costs and EQ-5D-5L scores were computed and compared between trial arms. Within BUMP2, analyses were conducted separately for CH and GH cohorts. WS4: Self-monitoring of urinary protein in hypertensive pregnancy 4.1 The UDIP study It was a diagnostic accuracy study that recruited 345 pregnant women to self-test for urinary protein using visually read dipsticks. The primary reference test was protein–creatinine ratio (PCR) and secondary index tests included testing by antenatal HCPs and an automated colorimetric reader. Primary outcome measures were sensitivity and specificity. 4.2 UDIP qualitative study In-depth interviews were carried out with 21 pregnant hypertensive or pre-eclamptic women who took part in the UDIP study, and 18 HCPs who had experience working in antenatal care. Five focus group totalling 15 participants were conducted with HCPs. WS5: Modelling of the potential long-term costs and consequences With no cost or effect differences observed overall or across pre-specified subgroups in the BUMP1 and BUMP2 trials, the need for long-term cost-effectiveness modelling was negated. Instead, model frameworks to facilitate future exploration of the potential long-term costs and effects of combining SMBP with BP management policies for the prevention of hypertension-related complications, were developed. The models cover the pregnancy pathway and a subsequent ten-year period to capture the risks, costs, and consequences of women developing cardiovascular disease. Model parameters are entered as distributions to enable probabilistic sensitivity analysis, and the frameworks facilitate results being presented for women with differing characteristics and for different intervention effect sizes. Results WS1: Development (Band R, Hinton L, Tucker KL, Chappell LC, Crawford C, Franssen M, et al. Intervention planning and modification of the BUMP intervention: a digital intervention for the early detection of raised blood pressure in pregnancy. Pilot Feasibility Stud 2019;5:153. https://doi.org/10.1186/s40814-019-0537-z; Hinton L, Hodgkinson J, Tucker KL, Rozmovits L, Chappell L, Greenfield S, et al. Exploring the potential for introducing home monitoring of blood pressure during pregnancy into maternity care: current views and experiences of staff – a qualitative study. BMJ Open 2020;10:e037874. https://doi.org/10.1136/bmjopen-2020-037874) Focus groups and interviews were conducted with 147 NHS staff at seven different hospital sites. Areas identified as important included: providing clear patient information and supporting staff in decision-making in the context of discrepant readings. Analyses suggested that SMBP would be welcomed by HCPs, while also highlighting potential barriers. This work and iterative development with pregnant women supported the development of a pragmatic and workable trial with user-friendly materials and app. WS2: Blood pressure self-monitoring during pregnancy for antihypertensive titration (Pealing LM, Tucker KL, Mackillop LH, Crawford C, Wilson H, Nickless A, et al.; OPTIMUM-BP Investigators. A randomised controlled trial of blood pressure self-monitoring in the management of hypertensive pregnancy. OPTIMUM-BP: a feasibility trial. Pregnancy Hypertens 2019;18:141–9. https://doi.org/10.1016/j.preghy.2019.09.018; Pealing L, Tucker KL, Fletcher B, Lawley E, Chappell LC, McManus RJ, Ziebland S. Perceptions and experiences of blood pressure self-monitoring during hypertensive pregnancy: a qualitative analysis of women’s and clinicians’ experiences in the OPTIMUM-BP trial. Pregnancy Hypertens 2022;30:113–23. https://doi.org/10.1016/j.preghy.2022.09.006) Women from four UK centres were randomised: 158/222 (71%) of those approached agreed, comprising 86 women with CH (55 SMBP, 31 control) and 72 with GH (49 SMBP, 23 control). Outcome data were available from 154 (97%). The median number of days with home BP readings per week was 5.5 [interquartile range (IQR) 3.1–6.5] for those with CH and 6.1 (4.5–6.7) with GH. Participating women persisted with the intervention for 80% time from enrolment until delivery. Recorded clinic and study BPs were similar for both groups. Interviews showed that the women found SMBP feasible and acceptable and were highly motivated and proactive in their monitoring. They reported greater control and knowledge, which provided reassurance. Most women reported that they responded appropriately for out-of-range readings or symptoms. WS3: Self-monitoring to improve the detection and management of raised blood pressure in pregnancy 3.1 The BUMP survey (Tucker KL, Hodgkinson J, Wilson HM, Crawford C, Stevens R, Lay-Flurrie S, et al. Current prevalence of self-monitoring of blood pressure during pregnancy: the BUMP survey. J Hypertens 2021;39:994–1001. https://doi.org/10.1097/HJH.0000000000002734) Completed surveys were received from 5181/5555 pregnant women (93%). The analysis showed that 983/5181 (19%) were currently SMBP. Around half of those were hypertensive 189/389 (49%) and 794/4792 (17%) were normotensive. However, only 482/983 (49%) of those that monitored their BP reported sharing this information with their obstetric and midwifery team. Comparison to hospital demographic data suggested that respondents were broadly representative.1 3.2.1 The BUMP1 trial (Tucker KL, Mort S, Yu LM, Campbell H, Rivero-Arias O, Wilson HM, et al.; BUMP Investigators. Effect of self-monitoring of blood pressure on diagnosis of hypertension during higher-risk pregnancy: the BUMP 1 randomized clinical trial. JAMA 2022;327:1656–65. https://doi.org/10.1001/jama.2022.4712) A total of 2441 women were randomised to BP self-monitoring plus usual care or usual care alone (n = 1218). Primary outcome data were available from 2346 (96%) women. Baseline characteristics were similar and 15.5% developed hypertension. Time to detection of clinic hypertension was not significantly different between groups: –1.6 days [95% confidence interval (CI) –8.1 to 4.9, p = 0.6]. There was no significant difference in the incidence of severe clinic hypertension [adjusted relative risk 1.2 (0.9 to 1.7), p = 0.3], in maternal and fetal outcomes, or serious adverse events. Most women who developed high BP had self-monitored their BP within a week of diagnosis (73%), and half had raised home BP readings prior to a clinic diagnosis. 3.2.2 The BUMP2 trial (Chappell LC, Tucker KL, Galal U, Yu L-M, Campbell H, Rivero-Arias O, et al.; BUMP 2 investigators. Effect of self-monitoring of blood pressure on blood pressure control in pregnant individuals with chronic or gestational hypertension: the BUMP 2 randomized clinical trial. JAMA 2022;327:1666–78. https://doi.org/10.1001/jama.2022.4726) Eight hundred and fifty pregnant women (454 with CH, 396 with GH) were enrolled into the BUMP2 trial: 430 were randomly allocated to BP self-monitoring (primary outcome available on 416 (96.7%) women) and 420 women to usual care (primary outcome available on 405 (96.4%) women). There was no evidence of difference in the mean systolic BP in those allocated to BP self-monitoring, in either the CH cohort [mean standard deviation (SD) systolic BP: 133.8 (10.3) mmHg in the self-monitoring group compared to 133.6 (11.1) mmHg in those with usual care (adjusted mean difference 0.03; 95% CI –1.73 to 1.79)] or the GH cohort [mean (SD) systolic BP: 137.6 (12.1) mmHg compared to 137.2 (10.8) mmHg in those with usual care (adjusted mean difference –0.03; 95% CI –2.29 to 2.24)]. 3.3 Qualitative process evaluation (Chisholm A, Tucker KL, Crawford C, Green M, Greenfield S, Hodgkinson J, et al. Self-monitoring blood pressure in pregnancy: evaluation of health professional experiences of the BUMP trials. BMC Pregnancy Childbirth 2024;35:88–95.https://doi.org/10.1016/j.preghy.2024.01.134) The majority of trial participants interviewed had positive experiences of self-monitoring, reporting it was reassuring, acceptable, convenient and sometimes led to the earlier detection of hypertension. Having their own series of BP readings could feel empowering but also introduced some uncertainty and new responsibility. Some women described delayed or selective reporting of high BP readings. Some women preferred not to self-monitor due to concerns about anxiety, fears of preoccupation with monitoring, low perceived risk of hypertension, or choosing to have an HCP present for BP measurement. Women’s accounts demonstrated that HCP engagement with BP self-monitoring varied. Healthcare professionals largely trusted home readings from the validated monitors used. Most said such measurements positively affected their clinical encounters and professional roles, amplifying the information on which to base decisions and enriching their relationships with women. Some felt SMBP gave women new responsibilities that required additional support from HCPs. 3.4 BUMP within-trial economic analyses(Campbell HE, Chappell LC, McManus RJ, Tucker KL, Crawford C, Green M, Rivero-Arias O. Detection and control of pregnancy hypertension using self-monitoring of blood pressure with automated telemonitoring: cost analyses of the BUMP randomized trials. Hypertension 2024;81:887–96. https://doi.org/10.1161/HYPERTENSIONAHA.123.22059) In BUMP1 and BUMP2, there were no significant differences between trial arms in EuroQol EQ-5D-5L scores at any time points. In both analyses, healthcare contacts and costs were also similar across resource use categories in each trial arm. In BUMP1, mean (standard error) total healthcare costs with SMBP and with usual care were £7200 (£323) and £7063 (£245) respectively, mean difference (95% CI), £151 (–£633 to £936). For the BUMP 2 chronic hypertension cohort, corresponding figures were £13,384 (£1230), £12,614 (£1081), and £323 (–£2904 to £3549) and for the gestational hypertension cohort were £11,456 (£901), £11,145 (£959), and £41 (–£2486 to £2567). WS4: Self-monitoring of urinary protein in hypertensive pregnancy WS4.1 UDIP (Jakubowski BE, Stevens R, Wilson H, Lavallee L, Brittain L, Crawford C, et al. Cross-sectional diagnostic accuracy study of self-testing for proteinuria during hypertensive pregnancies: the UDIP study. BJOG 2022;129:2142–8. https://doi.org/10.1111/1471-0528.17180) Hypertensive pregnant women were recruited: 335/345 (97%) had sufficient data to be included in the analysis of whom 118 (35.2%) had a positive PCR. Self-testing had a sensitivity of 0.71 [95% CI 0.62 to 0.79] and a specificity of 0.89 [95% CI 0.84 to 0.92] compared to PCR. Sensitivity and specificity of testing by HCPs and the colorimetric reader were similar: sensitivity 0.73 (95% CI 0.64 to 0.80) and 0.78 (95% CI 0.69 to 0.85) respectively; specificity 0.88 (95% CI 0.82 to 0.92) and 0.83 (95% CI 0.78 to 0.88) respectively. WS4.2 UDIP qualitative Associated qualitative work found that self-testing was acceptable to pregnant women and HCPs, and could provide an opportunity for pregnant women to be more involved in their care. WS5: Modelling of the potential long-term costs and consequences The model frameworks developed provide a facility for exploration of the potential cost-effectiveness of future SMBP-guided interventions for different cohorts of women affected by pregnancy hypertension and for differing levels of intervention effectiveness. We present no definitive cost-effectiveness results, instead running a series of hypothetical scenarios to illustrate the capabilities of the models. For example, simulating a hypothetical scenario in which a new SMBP-guided intervention could reduce the risk of a pregnant women developing pre-eclampsia by 10%, the modelling suggested that long-term cost-effectiveness could potentially vary between hypertensive pregnant women and women at risk of pregnancy hypertension. This is because hypertensive women face a greater likelihood of developing associated complications both during and following pregnancy, in turn suggesting a greater absolute level of benefit from a 10% reduction in complications via the mechanism of better BP control. Such hypotheses would of course require empirical testing in practice. Conclusions WS1: Development The BUMP intervention was developed and user tested for implementation in higher risk and hypertensive pregnant women in the BUMP trials. WS2: Blood pressure self-monitoring during pregnancy for antihypertensives titration – pilot trial This randomised feasibility trial of BP self-monitoring during hypertensive pregnancy indicated that a large RCT would be acceptable and feasible. WS3: Self-monitoring to improve the detection and management of raised blood pressure in pregnancy WS3.1: BUMP survey Healthcare professionals should be aware that many women are choosing to self-monitor their BP. They are advised to enquire about this proactively and consider providing information on BP monitoring in pregnancy. WS3.2.1: BUMP1 trial Self-monitoring of BP during higher risk pregnancy appears to be safe. However, it did not improve the detection of hypertension when used alongside usual care. Self-monitoring did provide prior notice of hypertension in many women suggesting it could be useful. Not all women will want to self-monitor meaning that an individualised approach will be needed. Further work is needed to assess the place of SMBP, for example, in remote consultations or alongside self-management. WS3.2.2: BUMP2 trial Blood pressure self-monitoring in pregnancy hypertension was not associated with a change in BP control, as assessed by clinic systolic BP, but appears to be safe, without evidence of harm or unintended deleterious effects on pregnancy outcomes. Not all women will want to self-monitor meaning that an individualised approach will be needed. Furthermore, the addition of further components of self-management may be required in order to achieve improvements in BP control and other pregnancy outcomes. WS3.3: Process evaluation The majority of women and HCPs involved in the trial found SMBP enhanced their experiences of the clinical encounter and the HCP–woman relationship. However, not all women found self-care helpful. Furthermore, selective or delayed reporting of raised readings, along with the pursuit of normal readings, and HCPs’ variable engagement with home readings could have impacted the performance of the BUMP intervention. SMBP by women in the usual care arm may have affected evidence for the intervention’s effectiveness in identifying or managing hypertension. WS3.4: Economic analysis The SMBP intervention as evaluated in the BUMP trials was not associated with changes in health-related quality of life or healthcare resource use or with, pregnancy hypertension. When coupled with findings that SMBP is both safe and acceptable to individuals, this is reassuring for healthcare providers upon whom the recent coronavirus
BACKGROUND:Hypertension induces structural and functional damage in multiple organs. Evidence of subclinical damage increases risk of vascular events and death but can be difficult to identify in the clinic. We developed a novel machine learning approach that quantifies current hypertension-associated multiorgan damage, mapping progression from health to advanced disease, in a pseudotemporal manner and predicts organ-specific disease progression trajectories. METHODS:We analyzed 566 multimodal imaging and nonimaging variables from 27 099 participants in the UK Biobank imaging substudy to develop a semisupervised contrastive trajectory inference (cTI) framework that models multiorgan alterations associated with hypertension exposure, including heart, brain, kidneys, vasculature, lungs, liver, and metabolic information. Model stability was validated through multiple internal validation steps, and external validity was tested on 5507 participants from the Atherosclerosis Risk in Communities study (ARIC). Clinical relevance was evaluated against existing risk scores and through ability to predict survival and incident multiorgan disease for up to 7 years, across both UK Biobank and ARIC. RESULTS:In the UK Biobank (mean age 63.27±7.48 years; 53.4% women) our global organ damage score (HyperScore) achieved an area under the curve of 0.964 (0.941-0.987) for identification of individuals with severe end-organ disease and robust stability in cross-validation with a mean root mean square error of 0.104±0.084. Survival odds differed significantly across HyperScore stages (P<0.001), whereas stratification by blood pressure was nonsignificant. We further revealed 6 hypertensive disease phenotypes (HyperTrajectory), characterized by predominant cardiac, lipoprotein, atherothrombosis, brain, cardiorenal, and liver features, respectively. External testing in ARIC confirmed stability of the model, with Jensen-Shannon distances as low as 0.10 for HyperScore distributions, without significant deviation in organ damage progression patterns (P>0.05) and consistent end-organ and outcome characteristics between ARIC and UK Biobank across HyperTrajectories. CONCLUSIONS:Machine learning-derived global organ damage scores are feasible in hypertension and enable identification of distinct hypertension-associated organ-disease phenotypes. New frameworks for hypertension assessment and monitoring using imaging to derive personalized risk assessment and phenotype-specific intervention may be achievable.
Introduction:Nearly half of pregnant women with moderate-to-severe chronic kidney disease (CKD) will require dialysis or lose ≥ 25% kidney function by 12 months after delivery with high rates of neonatal complications. No targeted approaches have been developed to improve maternal outcomes. Methods:Pregnant women with stage G2 to G5 CKD (< 25 weeks' gestation) at 8 centers in the UK were randomized to standard care or daily beetroot juice (dietary nitrate 400 mg) within an observational cohort. Exclusions were established dialysis, age < 18 years, major congenital fetal abnormality, multifetal pregnancy, and beetroot allergy. The primary outcome was recruitment rate/site/mo. Secondary outcomes included feasibility measures as well as maternal and fetal or neonatal clinical and safety events. Results:108 participants were randomized (54/arm); overall mean recruitment rate was 1.01/site/mo (SD: 0.90). Women receiving dietary nitrate with prepregnancy estimated glomerular filtration rate (eGFR) < 45 ml/min per 1.73 m2 tended to have lower median creatinine (Cr) concentrations postpartum than those on standard care (6 weeks: Cr, 176 [interquartile range, IQR: 165-194] μmol/l vs. 226 [IQR: 169-296] μmol/l, P = 0.23; 6 months: Cr, 173 [IQR: 152-175] μmol/l vs. 216 [IQR: 149-295] μmol/l, P = 0.18). Admission to a neonatal unit or neonatal intensive care unit (NICU) tended to be lower with dietary nitrate than with standard care (7/30 [23.3%] vs. 21/53 [39.6%], P = 0.13). Seven women receiving dietary nitrate (23.3%) experienced 11 serious adverse events (AEs, SAEs) compared with 27 women receiving standard care (50.9%) who had 53 SAEs (P = 0.02). In post hoc analysis, fewer participants in the dietary nitrate group took antihypertensive medications during pregnancy (11/30 [36.7%] vs. 35/53 [66.0%], P = 0.01). Conclusion:We successfully recruited to a multicenter interventional study of pregnant people with CKD with suggestion of maternal kidney and neonatal benefit. Further evidence of efficacy is needed from a powered randomized controlled trial.
Pre-eclampsia is a leading cause of maternal and perinatal morbidity and mortality, disproportionately affecting low-income and middle-income countries (LMICs). Limited access to diagnostic resources, delayed presentation, and health-system constraints contribute to later detection and higher rates of complications. Tools enabling early diagnosis and risk stratification could improve outcomes. Biomarkers, such as placental growth factor and soluble fms-like tyrosine kinase-1, improve accuracy and speed of pre-eclampsia diagnosis in high-income countries, reducing maternal adverse outcomes. The value of these biomarkers might be even greater in LMICs where women more frequently experience severe complications. Biomarker-based testing could help identify those requiring urgent intervention while allowing others to continue routine care, supporting efficient use of scarce resources. This Review summarises evidence on pre-eclampsia diagnosis in LMICs, including biomarker performance, emerging low-cost and point-of-care approaches, and areas of opportunity in low-resource environments, where the potential for benefit is greatest. Harnessing these diagnostics could enhance pre-eclampsia detection, support timely intervention, and ultimately reduce preventable deaths among women and babies.
BACKGROUND:Accurate diagnosis of pre-eclampsia in women presenting with suspected disease remains challenging. Placental growth factor (PlGF) assays are established diagnostic biomarkers, particularly before 34 weeks' gestation. Glycosylated fibronectin (GlyFn), a metabolic biomarker, may provide complementary diagnostic information. METHODS:Retrospective diagnostic accuracy study using stored serum samples from 242 women with suspected pre-eclampsia recruited to the PEACHES study at two London maternity centres. GlyFn concentrations were measured using the Lumella™ DiabetOmics point-of-care test. Diagnostic performance for prediction of pre-eclampsia within 2, 7, 14, and 28 days was evaluated across gestational windows and compared with Delfia Xpress PlGF and Lepzi® Quanti point-of-care PlGF assays tested in the same cohort. Receiver-operating characteristic curves, sensitivity, specificity, predictive values, and likelihood ratios were calculated. RESULTS:Pre-eclampsia occurred in 22.7% of participants (54/242). Optimal GlyFn thresholds were < 400 μg/mL for rule-out and ≥ 700 μg/mL for rule-in. Before 34 weeks' gestation, GlyFn < 400 μg/mL showed sensitivity 86.7% (95% CI 59.5-98.3) and negative predictive value 95.2% (83.8-99.4) for prediction within 14 days, although specificity was low (36.4%). PlGF assays showed higher diagnostic accuracy before 34 weeks (AUROC 0.88-0.90) compared with GlyFn (AUROC 0.70). GlyFn concentrations were moderately inversely correlated with PlGF (Spearman's ρ = - 0.42, p < 0.001). Exploratory analyses suggested improved discrimination when both biomarkers were combined. CONCLUSION:The Lumella™ GlyFn point-of-care is a promising biomarker for ruling out pre- eclampsia, particularly at later gestations. While PlGF remains superior for early preterm disease, GlyFn may provide complementary diagnostic information and warrants further prospective evaluation.
Abstract Background Pre-eclampsia is a multisystem disorder affecting 2.8% of pregnancies in the UK. It usually presents after 20-week gestation with new-onset high blood pressure and proteinuria. Complications include eclampsia, stroke, and HELLP syndrome for the mother and preterm birth, fetal growth restriction, and stillbirth for the baby. Delivery is the only definitive cure, with antenatal care focusing on early detection and management of complications and optimising timing of delivery. Previous studies have shown calcium supplementation may reduce the risk of pre-eclampsia, but findings are driven by large effects seen in small trials that have not been replicated in larger trials. Subgroup analysis suggests benefits may only be seen in women with low dietary calcium intake, so findings may not be applicable to populations with adequate dietary calcium. Although the largest benefits appear to be in high-risk women, data are very limited, with no large trials conducted. Methods CaPE is a two-arm parallel triple-blinded, placebo-controlled, multicentre, superiority randomised controlled trial testing the hypothesis that in pregnant women at increased risk, calcium supplementation is effective in reducing the occurrence of pre-eclampsia. The study will recruit 7756 women from approximately 60 obstetric units in hospitals across the UK. Women with a confirmed viable pregnancy, with gestation 22 + 0 weeks or less and deemed eligible for aspirin therapy based on either NICE guideline criteria (at least one high-risk factor or two or more moderate risk factors) or the Fetal Medicine Foundation (FMF) algorithm will be eligible to be randomised in a 1:1 ratio to receive either 2 g per day of calcium supplementation or placebo taken from 12 to 22 weeks, up to birth. The primary outcome is clinician diagnosis of pre-eclampsia, based on the ISSHP definition. Key secondary outcomes are severe pre-eclampsia index and preterm birth < 37 weeks; other secondary outcomes include the Pre-eclampsia Core Outcome Set (COS). Discussion Calcium supplementation in high-risk women is an attractive intervention due to its potential efficacy, low cost, and safety profile, but a definitive trial is required to confirm benefits. Trial registration ISRCTN 12033893. Registered on 25 May 2021.
BACKGROUND:PlGF (placental growth factor) concentrations are lower in preeclampsia, a major cause of maternal death; testing improves diagnosis and outcomes. We evaluated 2 novel, whole blood, point-of-care PlGF tests (RONIA and Lepzi Quanti) in a low-resource setting for predicting adverse outcomes. METHODS:A prospective observational cohort study was conducted in women with hypertension in Sierra Leone, each of which were 24 to 36+6 weeks of gestation. Eligible women underwent concealed RONIA and Lepzi Quanti PLGF testing. Optimal rule-out and rule-in thresholds were determined for predicting maternal (death and eclampsia) and perinatal (stillbirth, termination pre-viability, and neonatal death) composite outcomes. Sensitivity, specificity, negative predictive values, and positive predictive values were assessed. RESULTS:Analysis included women with RONIA (n=488) and Lepzi Quanti (n=140) PlGF tests. Optimal thresholds were >60 or >90 pg/mL (rule-out) and <20 or <12 pg/mL (rule-in) for RONIA and Lepzi Quanti, respectively. For tests <34 weeks, RONIA <60 pg/mL had high sensitivity and negative predictive value for ruling out maternal (94.9% and 94.6%) and perinatal (100%) composite outcomes. RONIA <20 pg/mL indicated higher risk (positive predictive values, 16.3% and 40.9% respectively). Lepzi Quanti <90 pg/mL had 100% sensitivity and negative predictive value for ruling out maternal and perinatal composites. Conversely, with Lepzi Quanti <12 pg/mL, nearly a quarter and a half of pregnancies experienced the maternal and perinatal composites (positive predictive values, 22.0% and 48.0%). Performance declined slightly at later gestations. CONCLUSIONS:Point-of-care PlGF testing shows accurate rule-out performance for serious outcomes, with potential for risk stratification in low-resource settings. For both tests, a minority of cases fell into an intermediate category, which would warrant increased surveillance to determine progress.
Objective To explore the role of shared decision-making (SDM) in the implementation of evidence-based practice in women with chronic hypertension planning birth and investigate the barriers and the facilitators in the provision of antenatal care.Methods A multimethod multisite approach was used including case-note review (n=55) and structured observations (n=18) to assess the provision of third trimester antenatal care. The barriers and facilitators to implementation were identified from semistructured qualitative interviews with healthcare professionals (n=13) and pregnant women (n=14) using inductive thematic analysis. The findings were integrated and evaluated using the ‘Three Talk Model of Shared Decision-making’.Setting and participants Pregnant women with chronic hypertension, some with superimposed pre-eclampsia and their principal carers at three National Health Service hospital trusts.Results Healthcare professionals delivering care to pregnant women with high blood pressure were aligned with most communication practices (set out in the Calgary-Cambridge communication guide). Pregnant women with hypertension who described being engaged in shared decisions about birth developed a trusting relationship with their maternity team. Despite frequent caesarean section birth (52%) and early term birth (median gestation at delivery 38 weeks (IQR1 37 weeks, IQR3 39 weeks) identified by case-note review; integrated data (observations, case-note review and qualitative interviews) found pregnant women with high blood pressure were not regularly provided with personalised information based on what they would find helpful, encouraged to share their own thoughts or offered choice in relation to timing or mode of birth. Uncertainty regarding the evidence around optimal timing of birth was the main barrier identified by professionals. Facilitators included training for professionals in SDM, midwife-led antenatal classes for high-risk women and multiprofessional clinics.Conclusions Strategies to promote more widespread adoption of SDM are likely to improve the experiences of women with high blood pressure making decisions about childbirth.
OBJECTIVE:To evaluate test performance of the point-of-care Lepzi® Quanti placental growth factor (PlGF) test to rule-in and rule-out pre-eclampsia at various time points, in women presenting with suspected preeclampsia. STUDY DESIGN:242 frozen plasma samples from women with suspected pre-eclampsia were analysed from a prospective cohort study. Participants were recruited from two obstetric tertiary referral centres in London. MAIN OUTCOME MEASURES:PlGF concentration was quantified using the Lepzi® Quanti PlGF test, which is a point-of-care PlGF test. Test performance for diagnosis of pre-eclampsia was evaluated at various thresholds, and at different gestations. The area under the receiver operator curve (AUROC) was determined for the Lepzi® Quanti PlGF test and compared to that of the nationally recommended Delfia® Xpress PlGF1-2-3 test, in the same cohort of participants. RESULTS:The LEPZI® Quanti PlGF test showed high test performance for rule-out of pre-eclampsia within seven and 28 days. A threshold of ≥ 129 pg/ml (in plasma) had high negative predictive value (NPV) for rule out of preeclampsia within seven days of sampling: NPV 96.9 % at < 34 weeks' gestation (95 % confidence interval (CI) 91.2-99.4), NPV 97.0 %; at 34 - 37 weeks' gestation (95 % CI 84.2-99.9), NPV 80.0 % at ≥ 37 weeks gestation (95 % CI 44.4-97.5). CONCLUSION:The LEPZI® Quanti PlGF test demonstrates high test performance for diagnosis of pre-eclampsia, comparable to test performance for validated, nationally recommended PlGF tests. The LEPZI® Quanti PlGF test is a whole blood, point-of-care option to optimise risk stratification, enhanced surveillance, and appropriate management strategies; this would be suitable for low- and middle-income settings, as well as high-income settings.
In brief:Ethnic disparities in hypertensive disorders of pregnancy (HDP) are well-described but poorly understood, with complex interplays between biological, environmental, socio-cultural and healthcare factors potentially contributing. This article provides a contemporary review of this topic and makes recommendations for research and clinical care to improve outcomes for minoritised women. Abstract:HDP affect approximately one in ten pregnancies and are associated with increased risk of adverse maternal and perinatal outcomes. Despite advances in prevention of pre-eclampsia and improved management of blood pressure in pregnancy, stark disparities in HDP incidence and outcomes persist across maternal ethnic groups. This article provides a contemporaneous review of the epidemiology of ethnic disparities in HDP, potential contributors to ethnic disparities, and how maternal ethnicity is currently conceptualised and utilised as a risk factor in clinical practice. We present the challenges of utilising ethnicity as a risk factor and suggest actions needed to tackle ethnic disparities in pregnancy hypertension. Women of Black ethnic backgrounds consistently experience a higher risk of pre-eclampsia, HDP and associated adverse outcomes compared to women of other ethnicities across diverse healthcare settings. While traditional cardiovascular risk factors and socioeconomic status contribute to these disparities, they do not fully explain the observed differences. Understanding these disparities requires research examining complex interactions across biological, behavioural, environmental, socio-cultural, and healthcare system factors. Ensuring appropriate diversity in HDP research is crucial for equitable application of incoming genomic and personalised medicine advances. While the fundamental drivers of ethnic disparities in HDP remain to be fully understood, healthcare systems should prioritise optimising blood pressure control during pregnancy and postpartum for women from minoritised ethnic backgrounds. Ensuring minoritised women with lived experience are equal partners in designing and implementing research and initiatives to address these disparities will be critical to their success.
BACKGROUND:Hypertensive pregnancy disorders are associated with long-term adverse cardiac and vascular remodeling post index pregnancy. The POP-HT trial (Physician Optimised Postpartum Hypertension Treatment) demonstrated that improved puerperal blood pressure control leads to reduced blood pressure and beneficial cardiac remodeling during the first year postpartum. This study describes the impact on postpartum vascular remodeling. METHODS:A prospective, randomized, open-label, blinded end point trial in a single UK hospital where 220 women were assigned 1:1 to intervention (self-management via physician-guided antihypertensive titration) or control (usual postnatal care via primary care doctor±midwife). Eligible participants were ≥18 years, with preeclampsia or gestational hypertension and requiring antihypertensives on discharge. Prespecified secondary vascular outcomes included aortic blood pressure and pulse wave velocity measured by Vicorder at baseline and 9 months postpartum, and additional cardiovascular magnetic resonance measures of aortic distensibility were performed. RESULTS:There were no baseline differences in aortic blood pressure or pulse wave velocity but by 9 months postpartum, aortic diastolic blood pressure was -5.2 mm Hg lower ([95% CI, -8.0 to -2.2]; P<0.001), and pulse wave velocity was -0.71 m/s lower ([95% CI, -1.42 to -0.06]; P=0.048) in the intervention arm compared with the control arm, which corresponded with greater aortic distensibility by 0.78×10-3 mm Hg-1 ([95% CI, 0.01 to 1.55]; P=0.046). CONCLUSIONS:Postpartum blood pressure self-monitoring combined with physician-guided medication titration is associated with reduced central arterial stiffness during the first year after a hypertensive pregnancy, in addition to the previously demonstrated effects on blood pressure and cardiac remodeling. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT04273854.