Monitoring the safety of COVID-19 vaccination in pregnancy in the UK: A national study using the UK Obstetric Surveillance System (UKOSS), UK Teratology Information Service (UKTIS) and Vaccination in Pregnancy (VIP) safety monitoring systems.

Background: COVID-19 vaccines are protective against disease. Pregnant women benefit from vaccination as they are at higher risk of poor maternal and neonatal outcomes following infection. Methods: Following regulatory approval of two COVID-19 vaccines in the United Kingdom, a rapid national study of vaccination in pregnancy was instituted using three existing safety surveillance platforms: UKOSS, UKTIS and VIP. This preliminary report describes the data collected up to the 15th June 2021. Results: There were 971 reports of COVID-19 vaccination in the UKOSS/UKTIS (n = 493) and VIP (n = 478) monitoring systems describing 908 individual pregnancies. Pfizer-BioNTech mRNA vaccination was most common (n = 501, 55.2%), most women were vaccinated in their second or third trimester (n = 566, 62.3%), and were mainly vaccinated due to occupational infection risk (n = 577, 63.5%). Conclusion: Obstetric outcome data will be obtained by December 2021. However, women should not delay vaccination whilst awaiting further safety data to emerge.

Monitoring the safety of COVID-19 vaccination in pregnancy in the UK: A national study using the UK Obstetric Surveillance System (UKOSS), UK Teratology Information Service (UKTIS) and Vaccination in Pregnancy (VIP) safety monitoring systems

Background COVID-19 vaccines are protective against disease. Pregnant women benefit from vaccination as they are at higher risk of poor maternal and neonatal outcomes following infection. Methods Following regulatory approval of two COVID-19 vaccines in the United Kingdom, a rapid national study of vaccination in pregnancy was instituted using three existing safety surveillance platforms: UKOSS, UKTIS and VIP. This preliminary report describes the data collected up to the 15th June 2021. Results There were 971 reports of COVID-19 vaccination in the UKOSS/UKTIS (n = 493) and VIP (n = 478) monitoring systems describing 908 individual pregnancies. Pfizer-BioNTech mRNA vaccination was most common (n = 501, 55.2%), most women were vaccinated in their second or third trimester (n = 566, 62.3%), and were mainly vaccinated due to occupational infection risk (n = 577, 63.5%). Conclusion Obstetric outcome data will be obtained by December 2021. However, women should not delay vaccination whilst awaiting further safety data to emerge.

A qualitative study of the dynamics of access to remote antenatal care through the lens of candidacy.

OBJECTIVE: We aimed to explore the experiences and perspectives of pregnant women, antenatal healthcare professionals, and system leaders to understand the impact of the implementation of remote provision of antenatal care during the COVID-19 pandemic and beyond. METHODS: We conducted a qualitative study involving semi-structured interviews with 93 participants, including 45 individuals who had been pregnant during the study period, 34 health care professionals, and 14 managers and system-level stakeholders. Analysis was based on the constant comparative method and used the theoretical framework of candidacy. RESULTS: We found that remote antenatal care had far-reaching effects on access when understood through the lens of candidacy. It altered women's own identification of themselves and their babies as eligible for antenatal care. Navigating services became more challenging, often requiring considerable digital literacy and sociocultural capital. Services became less permeable, meaning that they were more difficult to use and demanding of the personal and social resources of users. Remote consultations were seen as more transactional in character and were limited by lack of face-to-face contact and safe spaces, making it more difficult for women to make their needs - both clinical and social - known, and for professionals to assess them. Operational and institutional challenges, including problems in sharing of antenatal records, were consequential. There were suggestions that a shift to remote provision of antenatal care might increase risks of inequities in access to care in relation to every feature of candidacy we characterised. CONCLUSION: It is important to recognise the implications for access to antenatal care of a shift to remote delivery. It is not a simple swap: it restructures many aspects of candidacy for care in ways that pose risks of amplifying existing intersectional inequalities that lead to poorer outcomes. Addressing these challenges through policy and practice action is needed to tackle these risks.

Evidence and Recommendations on the Use of Telemedicine for the Management of Arterial Hypertension: An International Expert Position Paper.

Telemedicine allows the remote exchange of medical data between patients and healthcare professionals. It is used to increase patients' access to care and provide effective healthcare services at a distance. During the recent coronavirus disease 2019 (COVID-19) pandemic, telemedicine has thrived and emerged worldwide as an indispensable resource to improve the management of isolated patients due to lockdown or shielding, including those with hypertension. The best proposed healthcare model for telemedicine in hypertension management should include remote monitoring and transmission of vital signs (notably blood pressure) and medication adherence plus education on lifestyle and risk factors, with video consultation as an option. The use of mixed automated feedback services with supervision of a multidisciplinary clinical team (physician, nurse, or pharmacist) is the ideal approach. The indications include screening for suspected hypertension, management of older adults, medically underserved people, high-risk hypertensive patients, patients with multiple diseases, and those isolated due to pandemics or national emergencies.

Self-monitoring of blood pressure in pregnancy: A mixed methods evaluation of a national roll-out in the context of a pandemic.

OBJECTIVE: To evaluate how English maternity units implemented self-monitoring of blood pressure (SMBP) in pregnancy in response to the COVID-19 pandemic. DESIGN: Mixed methods including surveys, anonymised patient data and in-depth interviews with women. SETTING: Maternity units across England. PARTICIPANTS: 45 maternity units completed a survey about the implementation of SMBP (supported by the provision of guidance and blood pressure monitors) during the pandemic, 166 women completed a survey about their experiences of SMBP, and 23 women took part in in-depth interviews. Clinical data from 627 women undertaking SMBP were available from 13 maternity units. RESULTS: SMBP was predominantly used to provide additional BP monitoring for hypertensive or high-risk pregnant women. Overall maternity units and women were positive about its use in terms of reducing the need for additional face-to-face contacts and giving women more control and insight into their own BP. However, there were challenges in setting up SMBP services rapidly and embedding them within existing care pathways, particularly around interpreting readings and managing the provision of monitors. CONCLUSIONS: A considerable proportion of maternity units in England commenced a SMBP service for hypertensive or high-risk women from March 2020. There is a need for further research into appropriate care pathways, including guidance around white coat or masked hypertension and the use of SMBP postnatally.

Quality framework for remote antenatal care: qualitative study with women, healthcare professionals and system-level stakeholders.

BACKGROUND: High-quality antenatal care is important for ensuring optimal birth outcomes and reducing risks of maternal and fetal mortality and morbidity. The COVID-19 pandemic disrupted the usual provision of antenatal care, with much care shifting to remote forms of provision. We aimed to characterise what quality would look like for remote antenatal care from the perspectives of those who use, provide and organise it. METHODS: This UK-wide study involved interviews and an online survey inviting free-text responses with: those who were or had been pregnant since March 2020; maternity professionals and managers of maternity services and system-level stakeholders. Recruitment used network-based approaches, professional and community networks and purposively selected hospitals. Analysis of interview transcripts was based on the constant comparative method. Free-text survey responses were analysed using a coding framework developed by researchers. FINDINGS: Participants included 106 pregnant women and 105 healthcare professionals and managers/stakeholders. Analysis enabled generation of a framework of the domains of quality that appear to be most relevant to stakeholders in remote antenatal care: efficiency and timeliness; effectiveness; safety; accessibility; equity and inclusion; person-centredness and choice and continuity. Participants reported that remote care was not straightforwardly positive or negative across these domains. Care that was more transactional in nature was identified as more suitable for remote modalities, but remote care was also seen as having potential to undermine important aspects of trusting relationships and continuity, to amplify or create new forms of structural inequality and to create possible risks to safety. CONCLUSIONS: This study offers a provisional framework that can help in structuring thinking, policy and practice. By outlining the range of domains relevant to remote antenatal care, this framework is likely to be of value in guiding policy, practice and research.

Postpartum blood pressure self-management following hypertensive pregnancy: protocol of the Physician Optimised Post-partum Hypertension Treatment (POP-HT) trial.

INTRODUCTION: New-onset hypertension affects approximately 10% of pregnancies and is associated with a significant increase in risk of cardiovascular disease in later life, with blood pressure measured 6 weeks postpartum predictive of blood pressure 5-10 years later. A pilot trial has demonstrated that improved blood pressure control, achevied via self-management during the puerperium, was associated with lower blood pressure 3-4 years postpartum. Physician Optimised Post-partum Hypertension Treatment (POP-HT) will formally evaluate whether improved blood pressure control in the puerperium results in lower blood pressure at 6 months post partum, and improvements in cardiovascular and cerebrovascular phenotypes. METHODS AND ANALYSIS: POP-HT is an open-label, parallel arm, randomised controlled trial involving 200 women aged 18 years or over, with a diagnosis of pre-eclampsia or gestational hypertension, and requiring antihypertensive medication at discharge. Women are recruited by open recruitment and direct invitation around time of delivery and randomised 1:1 to, either an intervention comprising physician-optimised self-management of postpartum blood pressure or, usual care. Women in the intervention group upload blood pressure readings to a 'smartphone' app that provides algorithm-driven individualised medication-titration. Medication changes are approved by physicians, who review blood pressure readings remotely. Women in the control arm follow assessment and medication adjustment by their usual healthcare team. The primary outcome is 24-hour average ambulatory diastolic blood pressure at 6-9 months post partum. Secondary outcomes include: additional blood pressure parameters at baseline, week 1 and week 6; multimodal cardiovascular assessments (CMR and echocardiography); parameters derived from multiorgan MRI including brain and kidneys; peripheral macrovascular and microvascular measures; angiogenic profile measures taken from blood samples and levels of endothelial circulating and cellular biomarkers; and objective physical activity monitoring and exercise assessment. An additional 20 women will be recruited after a normotensive pregnancy as a comparator group for endothelial cellular biomarkers. ETHICS AND DISSEMINATION: IRAS PROJECT ID 273353. This trial has received a favourable opinion from the London-Surrey Research Ethics Committee and HRA (REC Reference 19/LO/1901). The investigator will ensure that this trial is conducted in accordance with the principles of the Declaration of Helsinki and follow good clinical practice guidelines. The investigators will be involved in reviewing drafts of the manuscripts, abstracts, press releases and any other publications arising from the study. Authors will acknowledge that the study was funded by the British Heart Foundation Clinical Research Training Fellowship (BHF Grant number FS/19/7/34148). Authorship will be determined in accordance with the ICMJE guidelines and other contributors will be acknowledged. TRIAL REGISTRATION NUMBER: NCT04273854.

Dexamethasone in Hospitalized Patients with Covid-19.

BACKGROUND: Coronavirus disease 2019 (Covid-19) is associated with diffuse lung damage. Glucocorticoids may modulate inflammation-mediated lung injury and thereby reduce progression to respiratory failure and death. METHODS: In this controlled, open-label trial comparing a range of possible treatments in patients who were hospitalized with Covid-19, we randomly assigned patients to receive oral or intravenous dexamethasone (at a dose of 6 mg once daily) for up to 10 days or to receive usual care alone. The primary outcome was 28-day mortality. Here, we report the final results of this assessment. RESULTS: A total of 2104 patients were assigned to receive dexamethasone and 4321 to receive usual care. Overall, 482 patients (22.9%) in the dexamethasone group and 1110 patients (25.7%) in the usual care group died within 28 days after randomization (age-adjusted rate ratio, 0.83; 95% confidence interval [CI], 0.75 to 0.93; P<0.001). The proportional and absolute between-group differences in mortality varied considerably according to the level of respiratory support that the patients were receiving at the time of randomization. In the dexamethasone group, the incidence of death was lower than that in the usual care group among patients receiving invasive mechanical ventilation (29.3% vs. 41.4%; rate ratio, 0.64; 95% CI, 0.51 to 0.81) and among those receiving oxygen without invasive mechanical ventilation (23.3% vs. 26.2%; rate ratio, 0.82; 95% CI, 0.72 to 0.94) but not among those who were receiving no respiratory support at randomization (17.8% vs. 14.0%; rate ratio, 1.19; 95% CI, 0.92 to 1.55). CONCLUSIONS: In patients hospitalized with Covid-19, the use of dexamethasone resulted in lower 28-day mortality among those who were receiving either invasive mechanical ventilation or oxygen alone at randomization but not among those receiving no respiratory support. (Funded by the Medical Research Council and National Institute for Health Research and others; RECOVERY ClinicalTrials.gov number, NCT04381936; ISRCTN number, 50189673.).

Effect of Hydroxychloroquine in Hospitalized Patients with Covid-19.

BACKGROUND: Hydroxychloroquine and chloroquine have been proposed as treatments for coronavirus disease 2019 (Covid-19) on the basis of in vitro activity and data from uncontrolled studies and small, randomized trials. METHODS: In this randomized, controlled, open-label platform trial comparing a range of possible treatments with usual care in patients hospitalized with Covid-19, we randomly assigned 1561 patients to receive hydroxychloroquine and 3155 to receive usual care. The primary outcome was 28-day mortality. RESULTS: The enrollment of patients in the hydroxychloroquine group was closed on June 5, 2020, after an interim analysis determined that there was a lack of efficacy. Death within 28 days occurred in 421 patients (27.0%) in the hydroxychloroquine group and in 790 (25.0%) in the usual-care group (rate ratio, 1.09; 95% confidence interval [CI], 0.97 to 1.23; P = 0.15). Consistent results were seen in all prespecified subgroups of patients. The results suggest that patients in the hydroxychloroquine group were less likely to be discharged from the hospital alive within 28 days than those in the usual-care group (59.6% vs. 62.9%; rate ratio, 0.90; 95% CI, 0.83 to 0.98). Among the patients who were not undergoing mechanical ventilation at baseline, those in the hydroxychloroquine group had a higher frequency of invasive mechanical ventilation or death (30.7% vs. 26.9%; risk ratio, 1.14; 95% CI, 1.03 to 1.27). There was a small numerical excess of cardiac deaths (0.4 percentage points) but no difference in the incidence of new major cardiac arrhythmia among the patients who received hydroxychloroquine. CONCLUSIONS: Among patients hospitalized with Covid-19, those who received hydroxychloroquine did not have a lower incidence of death at 28 days than those who received usual care. (Funded by UK Research and Innovation and National Institute for Health Research and others; RECOVERY ISRCTN number, ISRCTN50189673; ClinicalTrials.gov number, NCT04381936.).

Corticosteroids in the Management of Pregnant Patients With Coronavirus Disease (COVID-19).

Recent evidence supports the use of an early, short course of glucocorticoids in patients with COVID-19 who require mechanical ventilation or oxygen support. As the number of coronavirus disease 2019 (COVID-19) cases continues to increase, the number of pregnant women with the disease is very likely to increase as well. Because pregnant women are at increased risk for hospitalization, intensive care unit admission, and mechanical ventilation support, obstetricians will be facing the dilemma of initiating maternal corticosteroid therapy while weighing its potential adverse effects on the fetus (or neonate if the patient is postpartum and breastfeeding). Our objective is to summarize the current evidence supporting steroid therapy in the management of patients with acute respiratory distress syndrome and COVID-19 and to elaborate on key modifications for the pregnant patient.