48 results found
Mullins E, Perry A, 2023, £25 and a biscuit: women’s health research and public engagement in the UK, Research Involvement and Engagement, ISSN: 2056-7529
Osman MMA, Mullins E, Kleprlikova H, et al., 2023, Beetroot juice, exercise, and cardiovascular function in women planning to conceive, Journal of Hypertension, Pages: 1-8, ISSN: 0263-6352
OBJECTIVE: Prepregnancy optimization of cardiovascular function may reduce the risk of pre-eclampsia. We aimed to assess the feasibility and effect of preconception cardiovascular monitoring, exercise, and beetroot juice on cardiovascular parameters in women planning to conceive. DESIGN AND METHOD: Prospective single-site, open-label, randomized controlled trial. Thirty-two women, aged 18-45 years, were allocated into one of four arms (1 : 1 : 1 : 1): exercise, beetroot juice, exercise plus beetroot juice and no intervention for 12 weeks. Blood pressure (BP) was measured at home daily. Cardiac output (CO) and total peripheral resistance (TPR) were assessed via bio-impedance. RESULTS: Twenty-nine out of 32 (91%) participants completed the study. Adherence to daily BP and weight measurements were 81 and 78%, respectively (n = 29). Eight out of 15 (53%) of participants did not drink all the provided beetroot juice because of forgetfulness and taste. After 12 weeks, exercise was associated with a reduction in standing TPR (-278 ± 0.272 dynes s cm-5, P < 0.05), and an increase in standing CO (+0.88 ± 0.71 l/min, P < 0.05). Exercise and beetroot juice together was associated with a reduction in standing DBP ( 7 ± 6 mmHg, P < 0.05), and an increase in standing CO (+0.49 ± 0.66 l/min, P < 0.05). The control group showed a reduction in standing TPR ( 313 ± 387 dynes s cm-5) and standing DBP ( 8 ± 5mmHg). All groups gained weight. CONCLUSION: Exercise and beetroot juice in combination showed a signal towards improving cardiovascular parameters. The control group showed improvements, indicating that home measurement devices and regular recording of parameters are interventions in themselves. Nevertheless, interventions before pregnancy to improve cardiovascular parameters may alter the occurrence of hypertensive conditions during pregnancy and require further investigation in adequately powered studies.
Pinho-Gomes A-C, Mullins E, 2023, Inequalities in smoking among pregnant women in North West London, Journal of Public Health, Vol: 45, Pages: e518-e521, ISSN: 1741-3842
BackgroundLondon has the lowest smoking prevalence among pregnant women in England. However, it was unclear whether the low overall prevalence masked inequalities. This study investigated the prevalence of smoking among pregnant women in North West London stratified by ethnicity and deprivation.MethodsData regarding smoking status, ethnicity and deprivation were extracted from electronic health records collected by maternity services at Imperial Healthcare NHS Trust between January 2020 and August 2022.ResultsA total of 25 231 women were included in this study. At the time of booking of antenatal care (mean of 12 weeks), 4% of women were current smokers, 17% were ex-smokers and 78% never smokers. There were marked differences in the smoking prevalence between ethnic groups. Women of Mixed—White and Black Caribbean ethnicity and White Irish women had the highest prevalence of smoking (12 and 9%, respectively). There was an over 4-fold increase in the prevalence of smoking between the most and the least deprived groups (5.6 versus 1.3%).ConclusionsEven in a population with an overall low prevalence of smoking in pregnancy, women experiencing deprivation and from certain ethnic backgrounds have a high smoking prevalence and hence are the most likely to benefit from smoking cessation interventions.
Hirst J, Votruba N, Billot L, et al., 2023, A community-based intervention to improve screening, referral and follow-up of non-communicable diseases and anaemia amongst pregnant and postpartum women in rural India: study protocol for a cluster randomised trial, Trials, Vol: 24, Pages: 1-17, ISSN: 1745-6215
BackgroundMedical complications during pregnancy, including anaemia, gestational diabetes mellitus and hypertensive disorders of pregnancy place women are at higher risk of long-term complications. Scalable and low-cost strategies to integrate non- communicable disease screening into pregnancy care are needed. We aim to determine the effectiveness and implementation components of a community-based, digitally-enabled approach, “SMARThealth Pregnancy”, to improve health during pregnancy and the first year after birth.MethodsA pragmatic, parallel-group, cluster-randomised, type 2 hybrid effectiveness- implementation trial of a community-based, complex intervention in rural India to decrease anaemia (primary outcome, defined as haemoglobin < 12g/dL) and increase testing for haemoglobin, glucose and blood pressure (secondary outcomes) in the first year after birth. Primary Health Centres (PHCs) are the unit of randomisation. PHCs are eligible with: (1) >1 medical officer and >2 community health workers; and (2) capability to administer intravenous iron sucrose. Thirty PHCs in Telangana and Haryana, will be randomised 1:1 using a matched-pair design accounting for cluster size and distance from the regional centre. The intervention comprises: (i) an education programme for community health workers and PHC doctors; (ii) the SMARThealth Pregnancy App for health workers to support community-based screening, referral, and follow-up of high-risk cases; (iii) a dashboard for PHC doctors to monitor high-risk women in the community; (iv) supply chain monitoring for consumables and medications, and (v) stakeholder engagement to co-develop implementation and sustainability pathways. The comparator is usual care with additional health worker education. Secondary outcomes include implementation outcomes assessed by the RE-AIM framework (reach, effectiveness, adoption, implementation, maintenance), clinical endpoints (anaemia, diabetes, hypertension), clinical ser
Smith ER, Oakley E, Grandner GW, et al., 2023, Clinical risk factors of adverse outcomes among women with COVID-19 in the pregnancy and postpartum period: A sequential, prospective meta-analysis, American Journal of Obstetrics and Gynecology, Vol: 228, Pages: 161-177, ISSN: 0002-9378
OBJECTIVE: This sequential, prospective meta-analysis (sPMA) sought to identify risk factors among pregnant and postpartum women with COVID-19 for adverse outcomes related to: disease severity, maternal morbidities, neonatal mortality and morbidity, adverse birth outcomes. DATA SOURCES: We prospectively invited study investigators to join the sPMA via professional research networks beginning in March 2020. STUDY ELIGIBILITY CRITERIA: Eligible studies included those recruiting at least 25 consecutive cases of COVID-19 in pregnancy within a defined catchment area. STUDY APPRAISAL AND SYNTHESIS METHODS: We included individual patient data from 21 participating studies. Data quality was assessed, and harmonized variables for risk factors and outcomes were constructed. Duplicate cases were removed. Pooled estimates for the absolute and relative risk of adverse outcomes comparing those with and without each risk factor were generated using a two-stage meta-analysis. RESULTS: We collected data from 33 countries and territories, including 21,977 cases of SARS-CoV-2 infection in pregnancy or postpartum. We found that women with comorbidities (pre-existing diabetes, hypertension, cardiovascular disease) versus those without were at higher risk for COVID-19 severity and pregnancy health outcomes (fetal death, preterm birth, low birthweight). Participants with COVID-19 and HIV were 1.74 times (95% CI: 1.12, 2.71) more likely to be admitted to the ICU. Pregnant women who were underweight before pregnancy were at higher risk of ICU admission (RR 5.53, 95% CI: 2.27, 13.44), ventilation (RR 9.36, 95% CI: 3.87, 22.63), and pregnancy-related death (RR 14.10, 95% CI: 2.83, 70.36). Pre-pregnancy obesity was also a risk factor for severe COVID-19 outcomes including ICU admission (RR 1.81, 95% CI: 1.26,2.60), ventilation (RR 2.05, 95% CI: 1.20,3.51), any critical care (RR 1.89, 95% CI: 1.28,2.77), and pneumonia (RR 1.66, 95% CI: 1.18,2.33). Anemic pregnant women with COVID-19 also had in
Smith ER, Oakley E, Grandner GW, et al., 2023, Adverse maternal, fetal, and newborn outcomes among pregnant women with SARS-CoV-2 infection: an individual participant data meta-analysis, BMJ Global Health, Vol: 8, Pages: 1-19, ISSN: 2059-7908
Introduction Despite a growing body of research on the risks of SARS-CoV-2 infection during pregnancy, there is continued controversy given heterogeneity in the quality and design of published studies.Methods We screened ongoing studies in our sequential, prospective meta-analysis. We pooled individual participant data to estimate the absolute and relative risk (RR) of adverse outcomes among pregnant women with SARS-CoV-2 infection, compared with confirmed negative pregnancies. We evaluated the risk of bias using a modified Newcastle-Ottawa Scale.Results We screened 137 studies and included 12 studies in 12 countries involving 13 136 pregnant women.Pregnant women with SARS-CoV-2 infection—as compared with uninfected pregnant women—were at significantly increased risk of maternal mortality (10 studies; n=1490; RR 7.68, 95% CI 1.70 to 34.61); admission to intensive care unit (8 studies; n=6660; RR 3.81, 95% CI 2.03 to 7.17); receiving mechanical ventilation (7 studies; n=4887; RR 15.23, 95% CI 4.32 to 53.71); receiving any critical care (7 studies; n=4735; RR 5.48, 95% CI 2.57 to 11.72); and being diagnosed with pneumonia (6 studies; n=4573; RR 23.46, 95% CI 3.03 to 181.39) and thromboembolic disease (8 studies; n=5146; RR 5.50, 95% CI 1.12 to 27.12).Neonates born to women with SARS-CoV-2 infection were more likely to be admitted to a neonatal care unit after birth (7 studies; n=7637; RR 1.86, 95% CI 1.12 to 3.08); be born preterm (7 studies; n=6233; RR 1.71, 95% CI 1.28 to 2.29) or moderately preterm (7 studies; n=6071; RR 2.92, 95% CI 1.88 to 4.54); and to be born low birth weight (12 studies; n=11 930; RR 1.19, 95% CI 1.02 to 1.40). Infection was not linked to stillbirth. Studies were generally at low or moderate risk of bias.Conclusions This analysis indicates that SARS-CoV-2 infection at any time during pregnancy increases the risk of maternal death, severe maternal morbidities and neonatal morbidity, but not stillbirth or intrauterine growth r
Fantasia I, Zamagni G, Lees C, et al., 2022, Current practice in the diagnosis and management of fetal growth restriction: An international survey, Acta Obstetricia et Gynecologica Scandinavica, Vol: 101, Pages: 1431-1439, ISSN: 0001-6349
IntroductionThe aim of this survey was to evaluate the current practice in respect of diagnosis and management of fetal growth restriction among obstetricians in different countries.Material and methodsAn e-questionnaire was sent via REDCap with “click thru” links in emails and newsletters to obstetric practitioners in different countries and settings with different levels of expertise. Clinical scenarios in early and late fetal growth restriction were given, followed by structured questions/response pairings.ResultsA total of 275 participants replied to the survey with 87% of responses complete. Participants were obstetrician/gynecologists (54%; 148/275) and fetal medicine specialists (43%; 117/275), and the majority practiced in a tertiary teaching hospital (56%; 153/275). Delphi consensus criteria for fetal growth restriction diagnosis were used by 81% of participants (223/275) and 82% (225/274) included a drop in fetal growth velocity in their diagnostic criteria for late fetal growth restriction. For early fetal growth restriction, TRUFFLE criteria were used for fetal monitoring and delivery timing by 81% (223/275). For late fetal growth restriction, indices of cerebral blood flow redistribution were used by 99% (250/252), most commonly cerebroplacental ratio (54%, 134/250). Delivery timing was informed by cerebral blood flow redistribution in 72% (176/244), used from ≥32 weeks of gestation. Maternal biomarkers and hemodynamics, as additional tools in the context of early-onset fetal growth restriction (≤32 weeks of gestation), were used by 22% (51/232) and 46% (106/230), respectively.ConclusionsThe diagnosis and management of fetal growth restriction are fairly homogeneous among different countries and levels of practice, particularly for early fetal growth restriction. Indices of cerebral flow distribution are widely used in the diagnosis and management of late fetal growth restriction, whereas maternal biomarkers and hemodynam
Zielinska AP, Mullins E, Magni E, et al., 2022, Remote multimodality monitoring of maternal physiology from the first trimester to postpartum period: study results., Journal of Hypertension, Vol: 40, Pages: 2280-2291, ISSN: 0263-6352
OBJECTIVES: Current antenatal care largely relies on widely spaced appointments, hence only a fraction of the pregnancy period is subject to monitoring. Continuous monitoring of physiological parameters could represent a paradigm shift in obstetric care. Here, we analyse the data from daily home monitoring in pregnancy and consider the implications of this approach for tracking pregnancy health. METHODS: Prospective feasibility study of continuous home monitoring of blood pressure, weight, heart rate, sleep and activity patterns from the first trimester to 6 weeks postpartum. RESULTS: Fourteen out of 24 women completed the study (58%). Compared to early pregnancy [week 13, median heart rate (HR) 72/min, interquartile range (IQR) 12.8], heart rate increased by week 35 (HR 78/min, IQR 16.6; P = 0.041) and fell postpartum (HR 66/min, IQR 11.5, P = 0.021). Both systolic and diastolic blood pressure were lower at mid-gestation (week 20: SBP 103 mmHg, IQR 6.6; DPB 63 mmHg, IQR 5.3 P = 0.005 and P = 0.045, respectively) compared to early pregnancy (week 13, SBP 107 mmHg, IQR 12.4; DPB 67 mmHg, IQR 7.1). Weight increased during pregnancy between each time period analyzed, starting from week 15. Smartwatch recordings indicated that activity increased in the prepartum period, while deep sleep declined as pregnancy progressed. CONCLUSION: Home monitoring tracks individual physiological responses to pregnancy in high resolution that routine clinic visits cannot. Changes in the study protocol suggested by the study participants may improve compliance for future studies, which was particularly low in the postpartum period. Future work will investigate whether distinct adaptative patterns predate obstetric complications, or can predict long-term maternal cardiovascular health.
Mullins E, McCabe R, Bird SM, et al., 2022, Tracking the incidence and risk factors for SARS-CoV-2 infection using historical maternal booking serum samples, PLoS One, Vol: 17, Pages: e0273966-e0273966, ISSN: 1932-6203
The early transmission dynamics of SARS-CoV-2 in the UK are unknown but their investigation is critical to aid future pandemic planning. We tested over 11,000 anonymised, stored historic antenatal serum samples, given at two north-west London NHS trusts in 2019 and 2020, for total antibody to SARS-CoV-2 receptor binding domain (anti-RBD). Estimated prevalence of seroreactivity increased from 1% prior to mid-February 2020 to 17% in September 2020. Our results show higher prevalence of seroreactivity to SARS-CoV-2 in younger, non-white ethnicity, and more deprived groups. We found no significant interaction between the effects of ethnicity and deprivation. Derived from prevalence, the estimated incidence of seroreactivity reflects the trends observed in daily hospitalisations and deaths in London that followed 10 and 13 days later, respectively. We quantified community transmission of SARS-CoV-2 in London, which peaked in late March / early April 2020 with no evidence of community transmission until after January 2020. Our study was not able to determine the date of introduction of the SARS-CoV-2 virus but demonstrates the value of stored antenatal serum samples as a resource for serosurveillance during future outbreaks.
Womersley K, Hockham C, Mullins E, 2022, The Women's Health Strategy: ambitions need action and accountability., The BMJ, Vol: 378, Pages: o2059-o2059
Mullins E, Perry A, Banerjee J, et al., 2022, Pregnancy and neonatal outcomes of COVID-19: The PAN-COVID study., European Journal of Obstetrics Gynecology and Reproductive Biology, Vol: 276, Pages: 161-167, ISSN: 0301-2115
OBJECTIVE: To assess perinatal outcomes for pregnancies affected by suspected or confirmed SARS-CoV-2 infection. METHODS: Prospective, web-based registry. Pregnant women were invited to participate if they had suspected or confirmed SARS-CoV-2 infection between 1st January 2020 and 31st March 2021 to assess the impact of infection on maternal and perinatal outcomes including miscarriage, stillbirth, fetal growth restriction, pre-term birth and transmission to the infant. RESULTS: Between April 2020 and March 2021, the study recruited 8239 participants who had suspected or confirmed SARs-CoV-2 infection episodes in pregnancy between January 2020 and March 2021. Maternal death affected 14/8197 (0.2%) participants, 176/8187 (2.2%) of participants required ventilatory support. Pre-eclampsia affected 389/8189 (4.8%) participants, eclampsia was reported in 40/ 8024 (0.5%) of all participants. Stillbirth affected 35/8187 (0.4 %) participants. In participants delivering within 2 weeks of delivery 21/2686 (0.8 %) were affected by stillbirth compared with 8/4596 (0.2 %) delivering ≥ 2 weeks after infection (95 % CI 0.3-1.0). SGA affected 744/7696 (9.3 %) of livebirths, FGR affected 360/8175 (4.4 %) of all pregnancies. Pre-term birth occurred in 922/8066 (11.5%), the majority of these were indicated pre-term births, 220/7987 (2.8%) participants experienced spontaneous pre-term births. Early neonatal deaths affected 11/8050 livebirths. Of all neonates, 80/7993 (1.0%) tested positive for SARS-CoV-2. CONCLUSIONS: Infection was associated with indicated pre-term birth, most commonly for fetal compromise. The overall proportions of women affected by SGA and FGR were not higher than expected, however there was the proportion affected by stillbirth in participants delivering within 2 weeks of infection was significantly higher than those delivering ≥ 2 weeks after infection. We suggest that clinicians' thresh
Zielinska A, Mullins E, Lees C, 2022, The feasibility of multi-modality remote monitoring of maternal physiology during pregnancy, Medicine, Vol: 101, ISSN: 0025-7974
Objectives: Gestational hypertension affects 10% of pregnancies, may occur without warning and has wide ranging effects on maternal, fetal and infant health. Antenatal care largely relies on in-person appointments, hence only <4% of the pregnancy period is subject to routine clinical monitoring. Home monitoring offers a unique opportunity to collect granular data and identify trends in maternal physiology that could predict pregnancy compromise. Our objective was to investigate the feasibility of remote multi-domain monitoring of maternal cardiovascular health both in and after pregnancy. Methods: Prospective feasibility study of continuous remote monitoring of multiple modalities indicative of cardiovascular health from the first trimester to six weeks post-partum.Results: Twenty-four pregnant women were asked to monitor body weight, heart rate, blood pressure, activity levels and sleep patterns daily. Study participants took on average 4.3 (SD= 2.20) home recordings of each modality per week across the three trimesters and 2.0 post-partum (SD= 2.41), out of a recommended maximum of 7. Participant retention was 58.3%. Wearing a smartwatch daily was reported as feasible (8.6/10, SD= 2.3) and data could be entered digitally with ease (7.7/10, SD= 2.4). Conclusion: Remote digital monitoring of cardiovascular health is feasible for research purposes and hence potentially so for routine clinical care throughout and after pregnancy. 58% of women completed the study. Multiple modalities indicative of cardiovascular health can be measured in parallel, giving a global view that is representative of the whole pregnancy period in a way that current antenatal care is not.
Smith ER, Oakley E, He S, et al., 2022, Protocol for a sequential, prospective meta-analysis to describe coronavirus disease 2019 (COVID-19) in the pregnancy and postpartum periods, PLoS One, Vol: 17, ISSN: 1932-6203
We urgently need answers to basic epidemiological questions regarding SARS-CoV-2 infection in pregnant and postpartum women and its effect on their newborns. While many national registries, health facilities, and research groups are collecting relevant data, we need a collaborative and methodologically rigorous approach to better combine these data and address knowledge gaps, especially those related to rare outcomes. We propose that using a sequential, prospective meta-analysis (PMA) is the best approach to generate data for policy- and practice-oriented guidelines. As the pandemic evolves, additional studies identified retrospectively by the steering committee or through living systematic reviews will be invited to participate in this PMA. Investigators can contribute to the PMA by either submitting individual patient data or running standardized code to generate aggregate data estimates. For the primary analysis, we will pool data using two-stage meta-analysis methods. The meta-analyses will be updated as additional data accrue in each contributing study and as additional studies meet study-specific time or data accrual thresholds for sharing. At the time of publication, investigators of 25 studies, including more than 76,000 pregnancies, in 41 countries had agreed to share data for this analysis. Among the included studies, 12 have a contemporaneous comparison group of pregnancies without COVID-19, and four studies include a comparison group of non-pregnant women of reproductive age with COVID-19. Protocols and updates will be maintained publicly. Results will be shared with key stakeholders, including the World Health Organization (WHO) Maternal, Newborn, Child, and Adolescent Health (MNCAH) Research Working Group. Data contributors will share results with local stakeholders. Scientific publications will be published in open-access journals on an ongoing basis.
Smith ER, Oakley E, He S, et al., 2022, Protocol for a sequential, prospective meta-analysis to describe coronavirus disease 2019 (COVID-19) in the pregnancy and postpartum periods, PLoS One, ISSN: 1932-6203
<jats:title>Abstract</jats:title><jats:p>We urgently need answers to basic epidemiological questions regarding SARS-CoV-2 infection in pregnant and postpartum women and its effect on their newborns. While many national registries, health facilities, and research groups are collecting relevant data, we need a collaborative and methodologically rigorous approach to better combine these data and address knowledge gaps, especially those related to rare outcomes. We propose that using a sequential, prospective meta-analysis (PMA) is the best approach to generate data for policy- and practice-oriented guidelines. As the pandemic evolves, additional studies identified retrospectively by the steering committee or through living systematic reviews will be invited to participate in this PMA. Investigators can contribute to the PMA by either submitting individual patient data or running standardized code to generate aggregate data estimates. For the primary analysis, we will pool data using two-stage meta-analysis methods. The meta-analyses will be updated as additional data accrue in each contributing study and as additional studies meet study-specific time or data accrual thresholds for sharing. At the time of publication, investigators of 25 studies, including more than 76,000 pregnancies, in 41 countries had agreed to share data for this analysis. Among the included studies, 12 have a contemporaneous comparison group of pregnancies without COVID-19, and four studies include a comparison group of non-pregnant women of reproductive age with COVID-19. Protocols and updates will be maintained publicly. Results will be shared with key stakeholders, including the World Health Organization (WHO) Maternal, Newborn, Child, and Adolescent Health (MNCAH) Research Working Group. Data contributors will share results with local stakeholders. Scientific publications will be published in open-access journals on an ongoing basis.</jats:p>
Mylrea-Foley B, Thornton JG, Mullins E, et al., 2022, Perinatal and 2-year neurodevelopmental outcome in late preterm fetal compromise: the TRUFFLE 2 randomised trial protocol, BMJ Open, Vol: 12, Pages: 1-8, ISSN: 2044-6055
Introduction Following the detection of fetal growth restriction, there is no consensus about the criteria that should trigger delivery in the late preterm period. The consequences of inappropriate early or late delivery are potentially important yet practice varies widely around the world, with abnormal findings from fetal heart rate monitoring invariably leading to delivery. Indices derived from fetal cerebral Doppler examination may guide such decisions although there are few studies in this area. We propose a randomised, controlled trial to establish the optimum method of timing delivery between 32 weeks and 36 weeks 6 days of gestation. We hypothesise that delivery on evidence of cerebral blood flow redistribution reduces a composite of perinatal poor outcome, death and short-term hypoxia-related morbidity, with no worsening of neurodevelopmental outcome at 2 years.Methods and analysis Women with non-anomalous singleton pregnancies 32+0 to 36+6 weeks of gestation in whom the estimated fetal weight or abdominal circumference is <10th percentile or has decreased by 50 percentiles since 18–32 weeks will be included for observational data collection. Participants will be randomised if cerebral blood flow redistribution is identified, based on umbilical to middle cerebral artery pulsatility index ratio values. Computerised cardiotocography (cCTG) must show normal fetal heart rate short term variation (≥4.5 msec) and absence of decelerations at randomisation. Randomisation will be 1:1 to immediate delivery or delayed delivery (based on cCTG abnormalities or other worsening fetal condition). The primary outcome is poor condition at birth and/or fetal or neonatal death and/or major neonatal morbidity, the secondary non-inferiority outcome is 2-year infant general health and neurodevelopmental outcome based on the Parent Report of Children’s Abilities-Revised questionnaire.Ethics and dissemination The Study Coordination Centre has obtaine
Naji O, Souter V, Mullins E, et al., 2022, The blind spot: value‐based health care in obstetrics and gynaecology, The Obstetrician & Gynaecologist, Vol: 24, Pages: 67-72, ISSN: 1467-2561
Key contentContinuing financial constraints on the UK’s National Health Service means the need for clinicians to provide high-quality care in a cost-effective way has never been greater.While the medical education system equips doctors with skills to provide safe clinical care, it should also provide an understanding of healthcare costs and cost-effectiveness analysis.Value-based care is becoming a key paradigm in women’s health services, where clinicians must employ strategies for delivering value, rationalising costs and capitalising on the use of emerging technologies.The calculation of value of an intervention for providers and service users may differ; care must be taken to ensure this concept is adapted for, and not imposed on healthcare systems.Engaging trainees in systems transformation and embedding the concepts of ‘do no financial harm’ are essential to ensure sustainable healthcare services.Learning ObjectivesTo understand the principles of value-based health care.To highlight the importance of adopting ‘cost-conscious’ care within daily clinical practice.To learn the differences between ‘cost’, ‘charge’, ‘price’ and ‘reimbursement.To encourage developing value-based competencies for future medical workforce through utilising out of programme placements and digital resources.Ethical IssuesThe ethical obligation of clinicians to consider cost may encompass justice and equity. However, the impact of practicing value-based health care is yet to be evaluated.
Mullins E, Lees C, 2021, Responding to a pandemic: UK universities’ research into COVID-19
Girardelli S, Mullins E, Lees CC, 2021, COVID-19 and pregnancy: Lessons from 2020, Early Human Development, Vol: 162, Pages: 1-6, ISSN: 0378-3782
The outbreak and spread of the coronavirus disease 2019 pandemic has led to an unprecedented wealth of literature on the impact of human coronaviruses on pregnancy. The number of case studies and publications alone are several orders of magnitude larger than those published in all previous human coronavirus outbreaks combined, enabling robust conclusions to be drawn from observations for the first time. However, the importance of learning from previous human coronavirus outbreaks cannot be understated. In this narrative review, we describe what we consider to the major learning points arising from the SARS-CoV-2 pandemic in relation to pregnancy, and where these confound what might have been expected from previous coronavirus outbreaks.
Mullins E, 2021, Setting up post birth contraception services in NW London
FSRH eBulletin. In this month’s eFeature, Dr Edward Mullins, together with midwifery, obstetrics and SRH colleagues, describes the process of setting up a new clinical service to introduce post birth contraception for all women in North West London. They outline the considerations and requirements at each stage of developing the service, including staffing and other resources, building a business case for a sustaining the service and using routine clinical datasets to support service evaluation and improvement
Mullins E, Sharma S, McGregor A, 2021, Postnatal exercise interventions: a systematic review of adherence and effect, BMJ Open, Vol: 11, Pages: 1-10, ISSN: 2044-6055
Objective to evaluate adherence to and effect of postnatal physical activity (PA) interventions.Design systematic review of PA intervention randomised controlled trials in postnatal women. The initial search was carried out in September 2018, and updated in January 2021.Data sources Embase, MEDLINE, and Cochrane Central Register of Controlled Trials (CENTRAL) databases, hand-searching references of included studies. The 25 identified studies included 1466 postnatal women in community and secondary care settings.Eligibility criteria studies were included if the PA interventions were commenced and assessed in the postnatal year. Data extraction and synthesis data was extracted using a pre-specified extraction template and assessed independently by two reviewers using Cochrane ROB 1 tool.Results 1413 records were screened for potential study inclusion, full-text review was performed on 146 articles, 25 studies were included. The primary outcome was adherence to PA intervention. The secondary outcomes were the effect of the PA interventions on the studies’ specified primary outcome. We compared effect on primary outcome for supervised and unsupervised exercise interventions. Studies were small, median N= 66 (20-130). PA interventions were highly variable, targets for PA per week ranged from 60 -275 minutes per week. LTFU was higher (14.5% vs 10%) and adherence to intervention was lower (73.6% vs. 86%) for unsupervised vs. supervised studies.Conclusions studies of PA interventions inconsistently reported adherence and LTFU. Where multiple studies evaluated PA as an outcome, they had inconsistent effects, with generally low study quality and high risk of bias. Agreement for effect between studies was evident for PA improving physical fitness and reducing fatigue. Three studies showed no adverse effect of physical activity on breast feeding. High-quality research reporting adherence and LTFU is needed into how and when to deliver postnatal PA interventions to benefi
Laycock HC, Mullins E, 2021, The role of anaesthetists in women's health, Anaesthesia, Vol: 76, Pages: 3-5, ISSN: 0003-2409
Mullins E, Hudak ML, Banerjee J, et al., 2021, Pregnancy and neonatal outcomes of COVID-19: co-reporting of common outcomes from PAN-COVID and AAP SONPM registries, Ultrasound in Obstetrics and Gynecology, Vol: 57, Pages: 5733-581, ISSN: 0960-7692
OBJECTIVE: Few large cohort studies have reported data on maternal, fetal, perinatal and neonatal outcomes associated with SARS-CoV-2 infection in pregnancy. We report the outcome of infected pregnancies from a collaboration formed early during the pandemic between the investigators of two registries, the UK and global Pregnancy and Neonatal outcomes in COVID-19 (PAN-COVID) study and the US American Academy of Pediatrics Section on Neonatal Perinatal Medicine (AAP SONPM) National Perinatal COVID-19 Registry. METHODS: This was an analysis of data from the PAN-COVID registry (January 1st to July 25th 2020), which includes pregnancies with suspected or confirmed maternal SARS-CoV-2 infection at any stage in pregnancy, and the AAP SONPM National Perinatal COVID-19 registry (April 4th to August 8th 2020), which includes pregnancies with positive maternal testing for SARS-CoV-2 from 14 days before delivery to 3 days after delivery. The registries collected data on maternal, fetal, perinatal and neonatal outcomes. The PAN-COVID results are presented both overall for pregnancies with suspected or confirmed SARS-CoV-2 infection and separately in those with confirmed infection. RESULTS: We report on 4005 pregnant women with suspected or confirmed SARS-CoV-2 infection (1606 from PAN-COVID and 2399 from AAP SONPM). For obstetric outcomes, in PAN-COVID overall, those with confirmed infection in PAN-COVID and AAP SONPM, respectively, maternal death occurred in 0.5%, 0.5% and 0.2% of cases, early neonatal death in 0.2%, 0.3% and 0.3% of cases and stillbirth in 0.5%, 0.6% and 0.4% of cases. Delivery was pre-term (<37 weeks' gestation) in 12.0% of all women in PAN-COVID, in 16.2% of those women with confirmed infection in PAN-COVID and in 15.7% of women in AAP SONPM. Extremely preterm delivery (< 27 weeks' gestation) occurred in 0.5% of cases in PAN-COVID and 0.3% in AAP SONPM. Neonatal SARS-CoV-2 infection was reported in 0.8% of all deliver
Mullins E, Hudak M, Banerjee J, et al., 2021, Pregnancy and neonatal outcomes of COVID-19 – co-reporting of common outcomes from the PAN-COVID and AAP SONPM registry, Ultrasound in Obstetrics and Gynecology, ISSN: 0960-7692
<h4>Background</h4> Few large, cohort studies report data on individual’s maternal, fetal, perinatal, and neonatal outcomes associated with SARS-CoV-2 infection in pregnancy. We report outcomes from a collaboration formed early during the pandemic between the investigators of two registries, the UK and global Pregnancy and Neonatal outcomes in COVID-19 (PAN-COVID) study and the US American Academy of Pediatrics Section on Neonatal Perinatal Medicine (AAP SONPM) National Perinatal COVID-19 Registry. <h4>Methods</h4> PAN-COVID (suspected or confirmed SARS-CoV-2 infection at any stage in pregnancy) and the AAP SONPM registry (positive maternal testing for SARS-CoV-2 from 14 days before delivery to 3 days after delivery) studies collected data on maternal, fetal, perinatal and neonatal outcomes. PAN-COVID results are presented as all inclusions and those with confirmed SARS-CoV-2 infection only. <h4>Results</h4> We report 4004 women in pregnancy affected by suspected or confirmed SARS-CoV-2 infection (1606 from PAN-COVID and 2398 from the AAP SONPM) from January 1 st 2020 to July 25 th 2020 (PAN-COVID) and August 8 th (AAP SONPM). For obstetric outcomes in PAN-COVID and AAP SONPM, respectively, maternal death occurred in 0.5% and 0.17%, early neonatal death in 0.2% and 0.3%, and stillbirth in 0.50% and 0.65% of women. Delivery was pre-term (<37 weeks gestation) in 12% of all women in PAN-COVID, in 16.2% of those women with confirmed infection in PAN-COVID and 16.2% of women in AAP SONPM. Very preterm delivery (< 27 weeks’ gestation) occurred in 0.6% in PAN-COVID and 0.7% in AAP SONPM. Neonatal SARS-CoV-2 infection was reported in 0.8% of PAN-COVID all inclusions, 2.0% in PAN-COVID confirmed infections and 1.8% in the AAP SONPM study; the proportions of babies tested were 9.5%, 20.7% and 87.2% respectively. The proportion of SGA babies was 8.2% in PAN-COVID all inclusions, 9.7% in PAN-COVID confirmed infection and 9.6
Banerjee J, Mullins E, Townson J, et al., 2021, Pregnancy and Neonatal Outcomes in COVID-19: Study protocol for a global registry of women with suspected or confirmed SARS-CoV-2 infection in pregnancy and their neonates, understanding natural history to guide treatment and prevention, BMJ Open, Vol: 11, Pages: 1-6, ISSN: 2044-6055
Introduction: Previous novel coronavirus pandemics, Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS), observed an association of infection in pregnancy with pre-term delivery, stillbirth and increased maternal mortality. Coronavirus disease2019(COVID-19), caused by SARS-CoV-2 infection, is the largest pandemic in living memory. Rapid accrual of robust case data on women in pregnancy and their babies affected by suspectedCOVID-19or confirmed SARS-CoV-2 infection will inform clinical management and preventative strategies in the current pandemic and future outbreaks. Methods and analysis: The Pregnancy And Neonatal outcomes in COVID-19 (PAN-COVID) registry is an observational study collecting focussed data on outcomes of pregnant mothers who have had suspected COVID-19 in pregnancy or confirmed SARS-CoV-2 infection and their neonatesvia a web-portal. Amongst the women recruited to the PAN-COVID registry, the study will evaluate the incidence of:1. Miscarriage and pregnancy loss2. FGR and stillbirth 3. Pre-term delivery 4. Vertical transmission(suspected or confirmed) and early-onset neonatal SARS-CoV-2 infection Data will be centre based and collected on individual women and their babies. Verbal consent will be obtained, to reduce face-to-face contact in the pandemic whilst allowing identifiable data collection for linkage. Statistical analysis of the data will be carried out on a pseudonymised dataset by the study statistician. Regular reports will be distributed to collaborators on the study research questions. Ethics and dissemination: This study has received research ethics approval in the UK. For international centres, evidence of appropriate local approval will be required to participate, prior to entry of data to the database. The reports will be published regularly. The outputs of the study will be regularly disseminated to 4participants and collaborators on the study
Mehta NS, Mytton OT, Mullins EWS, et al., 2020, SARS-CoV-2 (COVID-19): What do we know about children? A systematic review., Clinical Infectious Diseases, Vol: 71, Pages: 2469-2479, ISSN: 1058-4838
BACKGROUND: Few paediatric cases of COVID-19 have been reported and we know little about the epidemiology in children, though more is known about other coronaviruses. We aimed to understand the infection rate, clinical presentation, clinical outcomes and transmission dynamics for SARS-CoV-2, in order to inform clinical and public health measures. METHODS: We undertook a rapid systematic review and narrative synthesis of all literature relating to SARS-CoV-2 in paediatric populations. The search terms also included SARS-CoV and MERS-CoV. We searched three databases and the COVID-19 resource centres of eleven major journals and publishers. English abstracts of Chinese language papers were included. Data were extracted and narrative syntheses conducted. RESULTS: 24 studies relating to COVID-19 were included in the review. Children appear to be less affected by COVID-19 than adults by observed rate of cases in large epidemiological studies. Limited data on attack rate indicate that children are just as susceptible to infection. Data on clinical outcomes are scarce but include several reports of asymptomatic infection and a milder course of disease in young children, though radiological abnormalities are noted. Severe cases are not reported in detail and there are little data relating to transmission. CONCLUSIONS: Children appear to have a low observed case rate of COVID-19 but may have similar rates to adults of infection with SARS-CoV-2. This discrepancy may be because children are asymptomatic or too mildly infected to draw medical attention, be tested and counted in observed cases of COVID-19.
Stampalija T, Thornton J, Marlow N, et al., 2020, Fetal cerebral Doppler changes and outcome in late preterm fetal growth restriction: prospective cohort study, Ultrasound in Obstetrics and Gynecology, Vol: 56, Pages: 173-181, ISSN: 0960-7692
ObjectivesTo explore the association between fetal umbilical and middle cerebral artery (MCA) Doppler abnormalities and outcome in late preterm pregnancies at risk of fetal growth restriction.MethodsThis was a prospective cohort study of singleton pregnancies at risk of fetal growth restriction at 32 + 0 to 36 + 6 weeks of gestation, enrolled in 33 European centers between 2017 and 2018, in which umbilical and fetal MCA Doppler velocimetry was performed. Pregnancies were considered at risk of fetal growth restriction if they had estimated fetal weight and/or abdominal circumference (AC) < 10th percentile, abnormal arterial Doppler and/or a fall in AC growth velocity of more than 40 percentile points from the 20‐week scan. Composite adverse outcome comprised both immediate adverse birth outcome and major neonatal morbidity. Using a range of cut‐off values, the association of MCA pulsatility index and umbilicocerebral ratio (UCR) with composite adverse outcome was explored.ResultsThe study population comprised 856 women. There were two (0.2%) intrauterine deaths. Median gestational age at delivery was 38 (interquartile range (IQR), 37–39) weeks and birth weight was 2478 (IQR, 2140–2790) g. Compared with infants with normal outcome, those with composite adverse outcome (n = 93; 11%) were delivered at an earlier gestational age (36 vs 38 weeks) and had a lower birth weight (1900 vs 2540 g). The first Doppler observation of MCA pulsatility index < 5th percentile and UCR Z‐score above gestational‐age‐specific thresholds (1.5 at 32–33 weeks and 1.0 at 34–36 weeks) had the highest relative risks (RR) for composite adverse outcome (RR 2.2 (95% CI, 1.5–3.2) and RR 2.0 (95% CI, 1.4–3.0), respectively). After adjustment for confounders, the association between UCR Z‐score and composite adverse outcome remained significa
Mylrea-Foley B, Bhide A, Mullins E, et al., 2020, Building consensus: thresholds for delivery in the TRUFFLE 2 randomized intervention study., Ultrasound in Obstetrics and Gynecology, Vol: 56, Pages: 285-287, ISSN: 0960-7692
Mullins E, Evans D, Viner RM, et al., 2020, Re: Effect of preoperative pelvic floor muscle training on pelvic floor muscle contraction and symptomatic and anatomical pelvic organ prolapse after surgery: randomized controlled trial Reply, ULTRASOUND IN OBSTETRICS & GYNECOLOGY, Vol: 56, Pages: 122-+, ISSN: 0960-7692
Mullins E, Evans D, Viner RM, et al., 2020, Coronavirus in pregnancy and delivery: rapid review, ULTRASOUND IN OBSTETRICS & GYNECOLOGY, Vol: 55, Pages: 586-592, ISSN: 0960-7692
Mullins E, Evans D, Viner R, et al., 2020, Coronavirus in pregnancy and delivery: rapid review and expert consensus, Publisher: Cold Spring Harbor Laboratory
BACKGROUND Person to person spread of COIVD-19 in the UK has now been confirmed. There are limited case series reporting the impact on women affected by coronaviruses (CoV) during pregnancy. In women affected by SARS and MERS, the case fatality rate appeared higher in women affected in pregnancy compared with non-pregnant women. We conducted a rapid, review to guide management of women affected by COVID -19 during pregnancy and developed interim practice guidance with the RCOG and RCPCH to inform maternity and neonatal service planningMETHODS Searches were conducted in PubMed and MedRxiv to identify primary case reports, case series, observational studies or randomised-controlled trial describing women affected by coronavirus in pregnancy and on neonates. Data was extracted from relevant papers and the review was drafted with representatives of the RCPCH and RCOG who also provided expert consensus on areas where data were lackingRESULTS From 9964 results on PubMed and 600 on MedRxiv, 18 relevant studies (case reports and case series) were identified. There was inconsistent reporting of maternal, perinatal and neonatal outcomes across case reports and series concerning COVID-19, SARS, MERS and other coronaviruses. From reports of 19 women to date affected by COVID-19 in pregnancy, delivering 20 babies, 3 (16%) were asymptomatic, 1 (5%) was admitted to ICU and no maternal deaths have been reported. Deliveries were 17 by caesarean section, 2 by vaginal delivery, 8 (42%) delivered pre-term. There was one neonatal death, in 15 babies who were tested there was no evidence of vertical transmission.CONCLUSIONS Morbidity and mortality from COVID-19 appears less marked than for SARS and MERS, acknowledging the limited number of cases reported to date. Pre-term delivery affected 42% of women hospitalised with COVID-19, which may put considerable pressure on neonatal services if the UK reasonable worse-case scenario of 80% of the population affected is realised. There has been
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