Maternity Units In England Research Articles

A randomised crossover design study comparing the pharmacokinetics and pharmacodynamics of two single Doses of ORal Aspirin (75 mg v 150mg) in pregnant women at risk of pre-eclampsia (DORA): implications on assessing aspirin response and patient adherence to therapy.

BackgroundPregnancy is associated with physiological changes that can alter the pharmacokinetic and pharmacodynamic profile of many drugs. Low-dose aspirin is used for pre-eclampsia (PE) prevention; however aspirin's pharmacokinetics and pharmacodynamics are poorly studied in pregnant women. ObjectiveThe aim of this study was to compare the pharmacodynamics of two common doses of aspirin (75 and 150 mg) used for PE prevention in high-risk women by examining their effect on thromboxane B2 (TbxB2) inhibition. A secondary objective sought to assess if salicylic acid could be used as means to evaluate adherence to aspirin. Study DesignFourteen pregnant women from a large maternity unit in England, eligible for prophylactic aspirin according to NICE guidance, were recruited into 2 x 2 randomised crossover trial. Blood samples were collected at baseline, 1, 2, 3, 4, 15, 16, 17, 18 and 19-hours post ingestion of either 75 or 150 mg of aspirin with a 7-day washout period. Plasma concentrations of salicylic acid (SA), the primary metabolite of aspirin, were determined using high performance liquid chromatography. Pharmacodynamic response to aspirin was assessed by measuring serum thromboxane B2 (TbxB2) concentrations by an enzyme-linked immunosorbent assay. Analyte data were compared using nonparametric test statistics for paired values (Wilcoxon Signed Rank Test) and areas under serum SA concentration versus time curve (AUC). Pharmacokinetic modelling was used to bridge the data arising from the overnight sampling break.The trial was registered with the ISRCTN (reg number ISRCTN14693054). ResultsA single dose of 150 mg of aspirin produced higher plasma exposure of SA in comparison to 75 mg (median SA AUC0-19 16.7 μg*h/ml (IQR 15.2-19.3) vs 6.8 μg*h/ml (IQR 6.1- 8.3), p<0.001). Pharmacokinetic models suggest that plasma SA concentrations could be detected above the maximum concentration recorded at baseline for the first 11 hours after 75 mg and for 12 hours after 150 mg aspirin dosing, providing a time frame to confirm recent aspirin ingestion. The 150 mg aspirin dose produced a greater normalised reduction in serum TbxB2 (median normalised reduction 95.7% (IQR 92.6%- 97.3%) than the 75 mg dose (median normalised reduction 84.6% (IQR 77.3-92.3%), p<0.007. ConclusionCompared to the 75 mg dose, 150 mg of aspirin more effectively inhibits TbxB2, providing rationale for further investigation of effectiveness of higher doses for pre-eclampsia prevention. Despite limitations, measuring serum SA concentration could still be used in future models to test adherence if done within 11-12 hours after ingestion.

Scaling up an intervention to protect preterm infants from neurodevelopmental disabilities — findings from a qualitative process evaluation comparing standard with enhanced quality improvement support packages for maternity units in England

BackgroundA quality improvement strategy (PReCePT) was used in a standard and enhanced format to scale up a clinical intervention (administering magnesium sulphate to women in preterm labour) across all maternity units in England to protect prematurely born infants from neurodevelopmental disabilities. Formal evaluations reported the effectiveness of the standard package alone in increasing the administration of magnesium sulphate. In this paper, we focus on the findings of the process evaluations, using normalisation process theory to explain how different implementation contexts generated the observed outcomes relating to normative and relational restructuring and sustainment.MethodsInterviews were conducted with key individuals in implementation of leadership positions nationally and locally. Interviews were analysed initially using the framework method. We then engaged recursively with NPT constructs to generate generalisable insights with pragmatic applicability in other settings.ResultsIn total, 72 interviews were conducted with good representation from units across England and staff from the National Academic Health Science Network. We found that all units irrespective of whether they received a standard or enhanced QI package were successful in the ‘normative restructuring’ of their setting to enable magnesium sulphate to be administered. This suggests that this implementation outcome is necessary to achieve improvements. However, it may not be sufficient to sustain the changes once additional resources have been withdrawn. Sustainment, our findings suggest, required ‘relational restructuring’ to accommodate altered workflows and facilitate the sharing of responsibilities and tasks in daily practice. Relational restructuring was more likely to have been achieved units receiving enhanced QI support but also happened in units with standard QI support, especially in those where perinatal team working was already well established.ConclusionUnlike other large QI-focused spread-and-scale programmes which failed to show any impact on outcomes, the PReCePT programme in both the enhanced and standard support packages led to improvements in the uptake of magnesium sulphate. The findings suggest that QI programmes interact with the enabling factors, such as strong interprofessional team working, already present in the setting. A standard package with minimal support was therefore sufficient in settings with enabling factors, but enhanced support was required in units where these were absent.

Can the diagnostic accuracy of newborn eye screening for congenital cataract be improved with digital imaging? The Digital Imaging versus Ophthalmoscopy (DIvO) study

Background Congenital cataract is the commonest cause of preventable child blindness in the world. It affects 1: 3000 babies, 60% of whom will have bilateral disease. Although screening of the newborn red-reflex with an ophthalmoscope is recommended, there are questions over this technique's accuracy, particularly in non-specialist hands. Several studies in enriched paediatric eye clinic populations have demonstrated superior accuracy when a digital image of the the eye's reflection to infrared light is evaluated. Aim This study uses a prototype infrared digital camera to test the hypothesis that the sensitivity and specificity of newborn screening using evaluation of the "infrared-reflex" image is superior to the standard red-reflex examination using ophthalmoscopy. Methods 140,000 newborn babies will be recruited into the study from at least 13 maternity units in England over an 18 month period. Babies will have both the standard red-reflex assessment and evaluation of the infrared-reflex using a prototype device. Since specialist gold-standard evaluation of every participant is impractical, bespoke data linkage requests to NHS England will be made. Data from the red-reflex evaluation and the presence of codes relating to cataract diagnosis and/or treatment in Hospital Episode Statistics (HES) will be retrieved for each participant a minimum of 6 months after their birth. This data will be used to calculate relative and absolute sensitivity and specificity for each screening test and comparison of accuracy using the McNemar test. Secondary outcome measures will include comparison of accuracy in different ethnic groups and screener usability scores. Anticipated impact Confirmation of the hypothesis will support development of a commercial screening device and the possible revision of newborn screening recommendations. Trial registration The study is registered with clinicaltrials.gov: NCT05282147.

‘Nesting networks’: Women's experiences of social network support in high-risk pregnancy

ObjectiveSocial support, an individual's social relationships (both online and offline), may provide protection against adverse mental health outcomes, such as anxiety and depression, which are high in women who have been hospitalised with high-risk pregnancy. This study explored the social support available to women at higher risk of preeclampsia during pregnancy by examining personal social networks. DesignSemi-structured interviews were accompanied by social network mapping using the web-based social networking tool GENIE. SettingEngland. ParticipantsTwenty-one women were recruited, of whom 18 were interviewed both during pregnancy and postnatally between April 2019 and April 2020. Nineteen women completed maps pre-natally, 17 women completed maps pre-natally and post-natally. Women were taking part in the BUMP study, a randomised clinical trial that included 2441 pregnant individuals at higher risk of preeclampsia and recruited at a mean of 20 weeks’ gestation from 15 hospital maternity units in England between November 2018 and October 2019. ResultsWomen's social networks tightened during pregnancy. The inner network changed most dramatically postnatally with women reporting fewer network members. Interviews revealed networks were primarily ‘real-life’ rather than online social networks, with members providing emotional, informational, and practical support. Women with a high-risk pregnancy valued the relationships they developed with health professionals during pregnancy, and would like their midwife to have a more central role in their networks by providing informational and, where needed, emotional support. The social network mapping data supported the qualitative accounts of changing networks across high-risk pregnancy. ConclusionWomen with a high-risk pregnancy seek to build “nesting networks” to support them through pregnancy into motherhood. Different types of support are sought from trusted sources. Midwives can play a key role. Practice ImplicationsAs well as highlighting other potential needs during pregnancy and the ways in which they can be met, support from midwives has a key role. Through talking to women early in their pregnancy, signposting information and explaining ways to contact health professionals regarding informational or emotional support would fill a gap that currently is met by other aspects of their network.

How are hospitals in England caring for women at risk of preterm birth in 2021? The influence of national guidance on preterm birth care in England: a national questionnaire

BackgroundNational guidance (Saving Babies Lives Care Bundle Version 2 (SBLCBv2) Element 5) was published in 2019, with the aim to standardise preterm care in England. We plan to identify how many preterm birth surveillance clinics there are in England, and to define current national management in caring for women who are both asymptomatic and high-risk of preterm birth, and who arrive symptomatically in threatened preterm labour, to assist preterm management both nationally and internationally.MethodsAn online survey comprising of 27 questions was sent to all maternity units in England between February 2021 to July 2021.ResultsData was obtained from 96 units. Quantitative analysis and free text analysis was then undertaken. We identified 78 preterm birth surveillance clinics in England, an increase from 30 preterm clinics in 2017. This is a staggering 160% increase in 4 years. SBLCBv2 has had a considerable impact in increasing preterm birth surveillance clinic services, with the majority (61%) of sites reporting that the NHS England publication influenced their unit in setting up their clinic. Variations exist at every step of the preterm pathway, such as deciding which risk factors warrant referral, distinguishing within particular risk factors, and offering screening tests and treatment options.ConclusionsWhile variations in care still do persist, hospitals have done well to increase preterm surveillance clinics, under the difficult circumstances of the COVID pandemic and many without specific additional funding.

National PReCePT Programme: a before-and-after evaluation of the implementation of a national quality improvement programme to increase the uptake of magnesium sulfate in preterm deliveries

ObjectiveTo evaluate the effectiveness and cost-effectiveness of the National PReCePT Programme (NPP) in increasing use of magnesium sulfate (MgSO4) in preterm births.DesignBefore-and-after study.SettingMaternity units (N=137) within NHS England and the...

Characteristics, treatment and care of pregnant women living with hepatitis B in England: findings from a national audit.

Around 0.4% of pregnant women in England have chronic hepatitis B virus (HBV) infection and need services to prevent vertical transmission. In this national audit, sociodemographic, clinical and laboratory information was requested from all maternity units in England for hepatitis B surface antigen-positive women initiating antenatal care in 2014. We describe these women's characteristics and indicators of access to/uptake of healthcare. Of 2542 pregnancies in 2538 women, median maternal age was 31 [IQR 27, 35] years, 94% (1986/2109) were non-UK born (25% (228/923) having arrived into the UK <2 years previously) and 32% (794/2473) had ⩾2 previous live births. In 39%, English levels were basic/less than basic. Antenatal care was initiated at median 11.3 [IQR 9.6, 14] gestation weeks, and 'late' (⩾20 weeks) in 10% (251/2491). In 70% (1783/2533) of pregnancies, HBV had been previously diagnosed and 11.8% (288/2450) had ⩾1 marker of higher infectivity. Missed specialist appointments were reported in 18% (426/2339). Late antenatal care and/or missed specialist appointments were more common in pregnancies among women lacking basic English, arriving in the UK ⩽2 years previously, newly HBV diagnosed, aged <25 years and/or with ⩾2 previous live births. We show overlapping groups of pregnant women with chronic HBV vulnerable to delayed or incomplete care.

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

ObjectiveTo evaluate how English maternity units implemented self-monitoring of blood pressure (SMBP) in pregnancy in response to the COVID-19 pandemic.DesignMixed methods including surveys, anonymised patient data and in-depth interviews with women.SettingMaternity units across England.Participants45 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.ResultsSMBP 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.ConclusionsA 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.

Cost-Utility Analysis of Planned Early Delivery or Expectant Management for Late Preterm Pre-eclampsia (PHOENIX)

AimThere is currently limited evidence on the costs associated with late preterm pre-eclampsia beyond antenatal care and post-natal discharge from hospital. The aim of this analysis is to evaluate the 24-month cost-utility of planned delivery for women with late preterm pre-eclampsia at 34+0–36+6 weeks’ gestation compared to expectant management from an English National Health Service perspective using participant-level data from the PHOENIX trial.MethodsWomen between 34+0 and 36+6 weeks’ gestation in 46 maternity units in England and Wales were individually randomised to planned delivery or expectant management. Resource use was collected from hospital records between randomisation and primary hospital discharge following birth. Women were followed up at 6 months and 24 months following birth and self-reported resource use for themselves and their infant(s) covering the previous 6 months. Women completed the EQ-5D 5L at randomisation and follow-up.ResultsA total of 450 women were randomised to planned delivery, 451 to expectant management: 187 and 170 women, respectively, had complete data at 24 months. Planned delivery resulted in a significantly lower mean cost per woman and infant(s) over 24 months (− £2711, 95% confidence interval (CI) − 4840 to − 637), with a mean incremental difference in QALYs of 0.019 (95% CI − 0.039 to 0.063). Short-term and 24-month infant costs were not significantly different between the intervention arms. There is a 99% probability that planned delivery is cost-effective at all thresholds below £37,000 per QALY gained.ConclusionThere is a high probability that planned delivery is cost-effective compared to expectant management. These results need to be considered alongside clinical outcomes and in the wider context of maternity care.Trial registration: ISRCTN registry ISRCTN01879376. Registered 25 November 2013.Supplementary InformationThe online version contains supplementary material available at 10.1007/s41669-022-00355-1.

Evaluation of the Growth Assessment Protocol (GAP) for antenatal detection of small for gestational age: The DESiGN cluster randomised trial.

Antenatal detection and management of small for gestational age (SGA) is a strategy to reduce stillbirth. Large observational studies provide conflicting results on the effect of the Growth Assessment Protocol (GAP) in relation to detection of SGA and reduction of stillbirth; to the best of our knowledge, there are no reported randomised control trials. Our aim was to determine if GAP improves antenatal detection of SGA compared to standard care. This was a pragmatic, superiority, 2-arm, parallel group, open, cluster randomised control trial. Maternity units in England were eligible to participate in the study, except if they had already implemented GAP. All women who gave birth in participating clusters (maternity units) during the year prior to randomisation and during the trial (November 2016 to February 2019) were included. Multiple pregnancies, fetal abnormalities or births before 24+1 weeks were excluded. Clusters were randomised to immediate implementation of GAP, an antenatal care package aimed at improving detection of SGA as a means to reduce the rate of stillbirth, or to standard care. Randomisation by random permutation was stratified by time of study inclusion and cluster size. Data were obtained from hospital electronic records for 12 months prerandomisation, the washout period (interval between randomisation and data collection of outcomes), and the outcome period (last 6 months of the study). The primary outcome was ultrasound detection of SGA (estimated fetal weight <10th centile using customised centiles (intervention) or Hadlock centiles (standard care)) confirmed at birth (birthweight <10th centile by both customised and population centiles). Secondary outcomes were maternal and neonatal outcomes, including induction of labour, gestational age at delivery, mode of birth, neonatal morbidity, and stillbirth/perinatal mortality. A 2-stage cluster-summary statistical approach calculated the absolute difference (intervention minus standard care arm) adjusted using the prerandomisation estimate, maternal age, ethnicity, parity, and randomisation strata. Intervention arm clusters that made no attempt to implement GAP were excluded in modified intention to treat (mITT) analysis; full ITT was also reported. Process evaluation assessed implementation fidelity, reach, dose, acceptability, and feasibility. Seven clusters were randomised to GAP and 6 to standard care. Following exclusions, there were 11,096 births exposed to the intervention (5 clusters) and 13,810 exposed to standard care (6 clusters) during the outcome period (mITT analysis). Age, height, and weight were broadly similar between arms, but there were fewer women: of white ethnicity (56.2% versus 62.7%), and in the least deprived quintile of the Index of Multiple Deprivation (7.5% versus 16.5%) in the intervention arm during the outcome period. Antenatal detection of SGA was 25.9% in the intervention and 27.7% in the standard care arm (adjusted difference 2.2%, 95% confidence interval (CI) -6.4% to 10.7%; p = 0.62). Findings were consistent in full ITT analysis. Fidelity and dose of GAP implementation were variable, while a high proportion (88.7%) of women were reached. Use of routinely collected data is both a strength (cost-efficient) and a limitation (occurrence of missing data); the modest number of clusters limits our ability to study small effect sizes. In this study, we observed no effect of GAP on antenatal detection of SGA compared to standard care. Given variable implementation observed, future studies should incorporate standardised implementation outcomes such as those reported here to determine generalisability of our findings. This trial is registered with the ISRCTN registry, ISRCTN67698474.

Implementation of Public Health England infection prevention and control guidance in maternity units in response to the COVID-19 pandemic

BackgroundThis study aimed to explore the successes and barriers to the implementation of Public Health England (PHE) infection prevention and control guidance in English maternity units during the COVID-19 pandemic.MethodsQualitative semi-structured interviews with obstetricians, midwives and neonatologists who worked in a maternity unit in England, UK, between March 2020 and July 2021. A thematic analysis was performed.ResultsSuccesses to the implementation of PHE guidance were related to existing infrastructure, training satisfaction, and organisational culture where subthemes considered the importance of a multidisciplinary approach, COVID-19 dedicated roles and hospital-wide communication. Barriers to implementation related to the applicability of the guidance with subthemes highlighting contradictions between updates, specialties and hospitals, undesirable timings and frequency of guidance updates, reductions in staff compliance and delayed implementation. Finally, the layout of some units made it difficult to implement various aspects of the guidance (e.g., social distancing), and many detailed issues related to information technology compatibility, a lack of availability and accessibility to appropriate personal protective equipment (PPE), and variations in testing arrangements between units.ConclusionsThis research provides information on the experiences of healthcare professionals working on maternity units during the COVID-19 pandemic. Findings illustrate the importance of effective hospital-wide communication and the need for consistent, easily understood guidance. These results will be used to inform the content of an expert panel consensus meeting.

Effect of Self-monitoring of Blood Pressure on Diagnosis of Hypertension During Higher-Risk Pregnancy

Inadequate management of elevated blood pressure (BP) is a significant contributing factor to maternal deaths. Self-monitoring of BP in the general population has been shown to improve the diagnosis and management of hypertension; however, little is known about its use in pregnancy. To determine whether self-monitoring of BP in higher-risk pregnancies leads to earlier detection of pregnancy hypertension. Unblinded, randomized clinical trial that included 2441 pregnant individuals at higher risk of preeclampsia and recruited at a mean of 20 weeks' gestation from 15 hospital maternity units in England between November 2018 and October 2019. Final follow-up was completed in April 2020. Participating individuals were randomized to either BP self-monitoring with telemonitoring (n = 1223) plus usual care or usual antenatal care alone (n = 1218) without access to telemonitored BP. The primary outcome was time to first recorded hypertension measured by a health care professional. Among 2441 participants who were randomized (mean [SD] age, 33 [5.6] years; mean gestation, 20 [1.6] weeks), 2346 (96%) completed the trial. The time from randomization to clinic recording of hypertension was not significantly different between individuals in the self-monitoring group (mean [SD], 104.3 [32.6] days) vs in the usual care group (mean [SD], 106.2 [32.0] days) (mean difference, -1.6 days [95% CI, -8.1 to 4.9]; P = .64). Eighteen serious adverse events were reported during the trial with none judged as related to the intervention (12 [1%] in the self-monitoring group vs 6 [0.5%] in the usual care group). Among pregnant individuals at higher risk of preeclampsia, blood pressure self-monitoring with telemonitoring, compared with usual care, did not lead to significantly earlier clinic-based detection of hypertension. ClinicalTrials.gov Identifier: NCT03334149.

Effect of Self-monitoring of Blood Pressure on Blood Pressure Control in Pregnant Individuals With Chronic or Gestational Hypertension

Inadequate management of elevated blood pressure is a significant contributing factor to maternal deaths. The role of blood pressure self-monitoring in pregnancy in improving clinical outcomes for the pregnant individual and infant is unclear. To evaluate the effect of blood pressure self-monitoring, compared with usual care alone, on blood pressure control and other related maternal and infant outcomes, in individuals with pregnancy hypertension. Unblinded, randomized clinical trial that recruited between November 2018 and September 2019 in 15 hospital maternity units in England. Individuals with chronic hypertension (enrolled up to 37 weeks' gestation) or with gestational hypertension (enrolled between 20 and 37 weeks' gestation). Final follow-up was in May 2020. Participants were randomized to either blood pressure self-monitoring using a validated monitor and a secure telemonitoring system in addition to usual care (n = 430) or to usual care alone (n = 420). Usual care comprised blood pressure measured by health care professionals at regular antenatal clinics. The primary maternal outcome was the difference in mean systolic blood pressure recorded by health care professionals between randomization and birth. Among 454 participants with chronic hypertension (mean age, 36 years; mean gestation at entry, 20 weeks) and 396 with gestational hypertension (mean age, 34 years; mean gestation at entry, 33 weeks) who were randomized, primary outcome data were available from 444 (97.8%) and 377 (95.2%), respectively. In the chronic hypertension cohort, there was no statistically significant difference in mean systolic blood pressure for the self-monitoring groups vs the usual care group (133.8 mm Hg vs 133.6 mm Hg, respectively; adjusted mean difference, 0.03 mm Hg [95% CI, -1.73 to 1.79]). In the gestational hypertension cohort, there was also no significant difference in mean systolic blood pressure (137.6 mm Hg compared with 137.2 mm Hg; adjusted mean difference, -0.03 mm Hg [95% CI, -2.29 to 2.24]). There were 8 serious adverse events in the self-monitoring group (4 in each cohort) and 3 in the usual care group (2 in the chronic hypertension cohort and 1 in the gestational hypertension cohort). Among pregnant individuals with chronic or gestational hypertension, blood pressure self-monitoring with telemonitoring, compared with usual care, did not lead to significantly improved clinic-based blood pressure control. ClinicalTrials.gov Identifier: NCT03334149.

Risk of postpartum haemorrhage is associated with ethnicity: A cohort study of 981801 births in England.

To determine the association between ethnic group and risk of postpartum haemorrhage in women giving birth. Cohort study. Maternity units in England. A total of 981801 records of births between 1 April 2015 and 31 March 2017 in a national clinical database. Multivariable logistic regression analyses with multiple imputation to account for missing data and robust standard errors to account for clustering within hospitals. Postpartum haemorrhage of ≥1500ml (PPH). A total of 28268 (2.9%) births were complicated by PPH. Risks were higher in women from black (3.9%) and other (3.5%) ethnic backgrounds. Following adjustment for maternal and fetal characteristics, and care at birth, there was evidence of an increased risk of PPH in women from all ethnic minority groups, with the largest increase seen in black women (adjusted OR1.54, 95%CI 1.45-1.63). The increase in risk was robust to sensitivity analyses, which included changing the outcome to PPH of ≥3000ml. In England, women from ethnic minority backgrounds have an increased risk of PPH, when maternal, fetal and birth characteristics are taken into account. Factors contributing to this increased risk need further investigation. Perinatal care for women from ethnic minority backgrounds should focus on preventative measures to optimise maternal outcomes. Women with an ethnic minority background giving birth in England have an increased risk of postpartum haemorrhage, even when characteristics of the mother, the baby and the care received are taken into account.

VP31.05: Pregnancy outcomes during the COVID‐19 pandemic: a population‐level analysis

There is conflicting international evidence regarding the effect of COVID-19 in pregnancy. We aimed to assess the effects of the COVID-19 pandemic on pregnancy outcomes. Retrospective population-level analysis using routinely collected clinical data at a large tertiary maternity unit in England. Singleton pregnancies completed beyond 16 weeks of gestation between 1 January 2016 and 31 January 2021 were included. Trends in birth weight, preterm birth, Caesarean section rate and perinatal mortality were analysed over time. Modelled COVID-19 transmission data were applied to deliveries since 1 January 2020 to assign an individual risk of COVID-19 to each pregnancy, expressed as attack rate. This was incorporated into a regression model of birth weight to account for under-ascertainment of COVID-19 cases. Asymptomatic n = 77 Mild n = 195 Moderate/Severe n = 29 43,802 pregnancies were included, with 8,343 since 1 January 2020 included in the model of birth weight. The risk of Caesarean section increased during the pandemic period (OR 1.11, 95% CI 1.03 to 1.19, p = 0.006). There was no change in the risk of stillbirth (OR 0.78, 95% CI 0.51 to 1.20, p = 0.26) or neonatal death (OR 0.89, 95% CI 0.54 to 1.47, p = 0.64). Accounting for other determinants of fetal growth there was no association between modelled COVID-19 attack rate (%) in any trimester and birth weight (first trimester p = 0.50, second p = 0.15, third p = 0.16). There was a trend towards an increase in birth weight z-score during the pandemic (Mean difference 0.04, 95% CI 0.00-0.07, p = 0.054). There was no significant change in the risk of preterm birth (OR 1.00, 95% CI 0.91-1.10, p = 0.93). We found no evidence of an overall effect of the COVID-19 pandemic on perinatal mortality or preterm birth, and in contrast to other reports there may a small increase in mean birth weight associated with the pandemic and lockdown periods. An increase in Caesarean section rate may represent a lower threshold for obstetric intervention due to COVID-19.

Planned delivery to improve postpartum cardiac function in women with preterm pre-eclampsia: the PHOEBE mechanisms of action study within the PHOENIX RCT

Background Women whose pregnancies are affected by hypertensive disorders of pregnancy, in particular preterm pre-eclampsia, are at increased risk of long-term cardiovascular morbidity and mortality. Objectives To investigate the hypothesis that prolongation of a pregnancy affected by preterm pre-eclampsia managed by expectant management compared with planned early delivery would result in worse cardiovascular function 6 months postpartum. Design A randomised controlled trial. Setting 28 maternity hospitals in England and Wales. Participants Women who were eligible for the Pre-eclampsia in HOspital: Early iNductIon or eXpectant management (PHOENIX) study were approached and recruited for the PHOEBE study. The PHOENIX (Pre-eclampsia in HOspital: Early iNductIon or eXpectant management) study was a parallel-group, non-masked, multicentre, randomised controlled trial that was carried out in 46 maternity units across England and Wales. This study compared planned early delivery with expectant management (usual care) with individual randomisation in women with late preterm pre-eclampsia who were 34 weeks’ gestation to less than 37 weeks’ gestation and having a singleton or dichorionic diamniotic twin pregnancy. Interventions Postpartum follow-up included medical history, blood pressure assessment and echocardiography. All women had blood sampling performed on at least two time points from recruitment to the 6-month follow-up for assessment of cardiac necrosis markers. Main outcome measures Primary outcome was a composite of systolic and/or diastolic dysfunction (originally by 2009 guidelines then updated by 2016 guidelines, with an amended definition of diastolic dysfunction). Analyses were by intention to treat, together with a per-protocol analysis for the primary and secondary outcomes. Results Between 27 April 2016 and 30 November 2018, 623 women were found to be eligible, of whom 420 (67%) were recruited across 28 maternity units in England and Wales. A total of 133 women were allocated to planned delivery, 137 women were allocated to expectant management and a further 150 received non-randomised expectant management within usual care. The mean time from enrolment to delivery was 2.5 (standard deviation 1.9) days in the planned delivery group compared with 6.8 (standard deviation 5.3) days in the expectant management group. There were no differences in the primary outcome between women in the planned delivery group and those in the expectant management group using either the 2009 (risk ratio 1.06, 95% confidence interval 0.80 to 1.40) or the 2016 definition (risk ratio 0.78, 95% confidence interval 0.33 to 1.86). Overall, 10% (31/321) of women had a left ventricular ejection fraction &lt; 55% and 71% of the cohort remained hypertensive at 6 months postpartum. No differences were observed between groups in cardiorespiratory outcomes prior to discharge from hospital or in systolic or diastolic blood pressure measurements. Variables associated with the primary outcome (2009 definition) at 6 months postpartum were maternal body mass index (adjusted odds ratio 1.33 per 5 kg/m2, 95% confidence interval 1.12 to 1.59 per 5 kg/m2) and maternal age (adjusted odds ratio 2.16, 95% confidence interval 1.44 to 3.22 per 10 years). Limitations include changing definitions regarding systolic and/or diastolic dysfunction. Conclusions Preterm pre-eclampsia results in persistence of hypertension in the majority of women with late preterm pre-eclampsia at 6 months postpartum and systolic dysfunction in 10%. Pre-eclampsia should not be considered a self-limiting disease of pregnancy alone. Future work Interventions aimed at reducing cardiovascular dysfunction. Trial registration Current Controlled Trials ISRCTN01879376. Funding This project was funded by the Efficacy and Mechanism Evaluation (EME) programme, a Medical Research Council and National Institute for Health Research (NIHR) partnership. This will be published in full in Efficacy and Mechanism Evaluation; Vol. 8, No. 12. See the NIHR Journals Library website for further project information.

Adherence with blood pressure self-monitoring in women with pregnancy hypertension, and comparisons to clinic readings: A secondary analysis of OPTIMUM-BP.

To assess adherence to self-monitoring of blood pressure (SMBP), and differences between SMBP and clinic readings, in a self-monitoring intervention for managing pregnancy hypertension. OPTIMUM-BP was an unmasked randomised controlled clinical trial. 154 women with pregnancy hypertension from four maternity units in England were recruited and randomised to SMBP or usual care. This secondary analysis included 91 women randomised to self-monitoring who provided BP readings. Trial instructions were for daily SMBP. Adherence was calculated as proportion of days on which SMBP readings were taken. Proportion of weeks in which at least 4 and at least 2 SMBP readings were taken was also calculated. Mean differences between clinic and SMBP measurements were calculated. Self-monitored BP data were available for 49 women with chronic hypertension and 42 women with gestational hypertension. Median percentage of days with SMBP readings was 77% (IQR 51, 89) in the chronic hypertension group and 85% (IQR 52, 95) in the gestational hypertension group. Adherence did not vary by different socio-demographic groups. Mean difference (95% CI) between clinic and SMBP for systolic BP was 0.99mmHg (-1.44, 3.41; chronic hypertension) and 3.76mmHg (0.75, 6.78; gestational hypertension) and for diastolic BP was 3.03mmHg (0.93, 5.12; chronic hypertension) and 3.27mmHg (0.56, 5.98; gestational hypertension). Adherence to self-monitoring was good and differences between SMBP and clinic readings were small. These findings offer reassurance about the use of self-monitoring at a time when it is being increasingly implemented in maternity settings.

OASI2: a cluster randomised hybrid evaluation of strategies for sustainable implementation of the Obstetric Anal Sphincter Injury Care Bundle in maternity units in Great Britain.

BackgroundThe Obstetric Anal Sphincter Injury (OASI) Care Bundle comprises four primary and secondary prevention practices that target the rising rates of severe perineal tearing during childbirth, which can have severe debilitating consequences for women. The OASI Care Bundle was implemented in 16 maternity units in Britain in the OASI1 project (2017-2018), which demonstrated the care bundle’s effectiveness in reducing OASI rates. In OASI2, the care bundle will be scaled up to 20 additional National Health Service (NHS) maternity units in a hybrid effectiveness-implementation study that will examine the effectiveness of strategies used to introduce, implement and sustain the care bundle.MethodsOASI2 is a two-arm cluster-randomised control trial (C-RCT) of maternity units in England, Scotland and Wales, with an additional non-randomised study arm. C-RCT arm 1 (peer support, n = 10 units) will be supported by ‘buddy’ units to implement the OASI Care Bundle. C-RCT arm 2 (lean implementation, n = 10 units) will implement without external support. The additional study arm (sustainability, n = 10 units) will include some original OASI1 units to evaluate the care bundle’s sustainability and OASI rates over time, from before OASI1 and through the end of OASI2. Units in all three study arms will receive an Implementation Toolkit with training resources and implementation support. The C-RCT arms will be compared in terms of OASI rate reduction (primary effectiveness outcome) and clinicians’ adoption of the care bundle (primary implementation outcome). Clinical data will be collated from maternity information systems; implementation data will be collected through validated surveys with women and clinicians, supplemented by qualitative methods. Descriptive statistics and regression modelling will be used for analysis. Emergent themes from the qualitative data will be assessed using framework analysis.DiscussionOASI2 will study the impact of various implementation strategies used to introduce and sustain the OASI Care Bundle, and how these strategies affect the bundle’s clinical effectiveness. The study will generate insights into how to effectively scale-up and sustain uptake and coverage of similar interventions in maternity units. A locally adaptable ‘implementation blueprint’ will be produced to inform development of future guidelines to prevent perineal trauma.Trial registrationISRCTN26523605

Healthy eating and lifestyle in pregnancy (HELP): a cluster randomised trial to evaluate the effectiveness of a weight management intervention for pregnant women with obesity on weight at 12 months postpartum

ObjectiveTo assess whether a weight management intervention for pregnant women with obesity was effective in reducing body mass index (BMI) 12 months after giving birth.MethodsPragmatic, cluster randomised controlled trial (RCT) with embedded cost-effectiveness analysis. 598 women with a BMI of ≥30 kg/m2 (between 12 and 20 weeks gestation) were recruited from 20 secondary care maternity units in England and Wales. BMI at 12 months postpartum was the primary outcome. A range of clinical and behavioural secondary outcomes were examined.InterventionsWomen attending maternity units randomised to intervention were invited to a weekly weight management group, which combined expertise from a commercial weight loss programme with clinical advice from midwives. Both intervention and control participants received usual care and leaflets on diet and physical activity in pregnancy.ResultsMean (SD) BMI at 12 months postpartum was 36.0 kg/m2 (5.2) in the control group, and 37.5 kg/m2 (6.7) in the intervention group. After adjustment for baseline BMI, the intervention effect was −0.02 (95% CI −0.04 to 0.01). The intervention group had an improved healthy eating score (3.08, 95% CI 0.16 to 6.00, p < 0.04), improved fibre score (3.22, 1.07 to 5.37, p < 0.01) and lower levels of risky drinking at 12 months postpartum compared to the control group (OR 0.45, 0.27 to 0.74, p < 0.002). The net incremental monetary benefit was not statistically significantly different between arms, although the probability of the intervention being cost-effective was above 60%, at policy-relevant thresholds.ConclusionsThere was no significant difference between groups on the primary outcome of BMI at 12 months. Analyses of secondary outcomes indicated improved healthy eating and lower levels of risky drinking.Trial registration: Current Controlled Trials ISRCTN25260464.

The effects of perineal trauma on immediate self-reported birth experience in first-time mothers

Introduction Childbirth can sometimes be stressful or traumatic, and previous research has considered how birth complications and interventions may contribute to a negative birth experience. One of the most frequent complications during birth is trauma to the perineum. The aim of this study was to investigate whether different levels of perineal trauma were associated with differences in women’s evaluation of their birth experience. Materials and methods As part of a longitudinal cohort study, the self-reported birth experiences of 202 primiparous women were compared based on the degree of perineal trauma they had experienced. Women who had given birth for the first time, vaginally and within the last 48 h in a large tertiary maternity unit in England were invited to take part. Data were collected from their hospital records with their consent and using the Childbirth Experience Questionnaire (CEQ), Experience of Birth Scale (EBS) and a perineal pain Visual Analogue Scale (VAS). Results Women with an obstetric anal sphincter injury (OASI) or episiotomy reported a more negative overall birth experience and perceived themselves as having less ability to give birth compared to those with a 1st/2nd degree sutured tear. Those with an episiotomy also reported feeling less involved in decision making processes during their birth. Significant differences remained between the OASI and 1st/2nd degree tear groups when controlling for factors known to affect birth experience, highlighting severe perineal trauma as a potential contributor to more negative birth experience. Conclusions Perineal trauma may affect a woman’s birth experience. Experiencing an episiotomy should not be overlooked as a potential contributor, especially during instrumental birth and in the absence of involved decision making. Further research is needed to disentangle the effects of episiotomy on birth experience, to explore the care needs of women with different degrees of perineal trauma and to explore how a negative birth experience may contribute to poor psychological health in the longer term.