2. Labour and birth.

This chapter describes the national guidance for care during labour and childbirth in the United Kingdom during the COVID-19 pandemic. The content largely draws attention on the guidance developed by the Royal College of Obstetricians (RCOG) and the Royal College of Midwives (RCM), and specific guidance on infection prevention and control measures from Public Health England. The key areas addressed are as follows: The chapter refers to some of the ways in which the guidance was translated in practice. The guidance was developed using a rapid analysis approach to emerging research and evidence, along with evidence from previous experiences of coronavirus combined with consensus expert opinion from all key professionals providing maternity care in the UK. WHAT IS KNOWN: The UK RCOG/RCM COVID-19 guidance was widely accepted across the UK maternity services and also worldwide as a reliable and credible source of information to shape care during the pandemic. WHAT IS NOT KNOWN: The full impact of the pandemic on the experiences and outcomes for babies and women of pregnancy, childbirth, and early parenting in the UK. The impact of the new approaches to intrapartum care on experiences and outcomes for women, babies, and families. The impact of the changes required to intrapartum care as a result of the pandemic on the professional care provided; in terms of pressure created by rapidly changing approaches to care and restrictions on the ability to provide normal levels of care.

Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial.

BACKGROUND: 2·6 million pregnancies were estimated to have ended in stillbirth in 2015. The aim of the AFFIRM study was to test the hypothesis that introduction of a reduced fetal movement (RFM), care package for pregnant women and clinicians that increased women's awareness of the need for prompt reporting of RFM and that standardised management, including timely delivery, would alter the incidence of stillbirth. METHODS: This stepped wedge, cluster-randomised trial was done in the UK and Ireland. Participating maternity hospitals were grouped and randomised, using a computer-generated allocation scheme, to one of nine intervention implementation dates (at 3 month intervals). This date was concealed from clusters and the trial team until 3 months before the implementation date. Each participating hospital had three observation periods: a control period from Jan 1, 2014, until randomised date of intervention initiation; a washout period from the implementation date and for 2 months; and the intervention period from the end of the washout period until Dec 31, 2016. Treatment allocation was not concealed from participating women and caregivers. Data were derived from observational maternity data. The primary outcome was incidence of stillbirth. The primary analysis was done according to the intention-to-treat principle, with births analysed according to whether they took place during the control or intervention periods, irrespective of whether the intervention had been implemented as planned. This study is registered with www.ClinicalTrials.gov, number NCT01777022. FINDINGS: 37 hospitals were enrolled in the study. Four hospitals declined participation, and 33 hospitals were randomly assigned to an intervention implementation date. Between Jan 1, 2014, and Dec, 31, 2016, data were collected from 409 175 pregnancies (157 692 deliveries during the control period, 23 623 deliveries in the washout period, and 227 860 deliveries in the intervention period). The incidence of stillbirth was 4·40 per 1000 births during the control period and 4·06 per 1000 births in the intervention period (adjusted odds ratio [aOR] 0·90, 95% CI 0·75-1·07; p=0·23). INTERPRETATION: The RFM care package did not reduce the risk of stillbirths. The benefits of a policy that promotes awareness of RFM remains unproven. FUNDING: Chief Scientist Office, Scottish Government (CZH/4/882), Tommy's Centre for Maternal and Fetal Health, Sands.

Can promoting awareness of fetal movements and focusing interventions reduce fetal mortality? A stepped-wedge cluster randomised trial (AFFIRM).

BACKGROUND: In 2013, the stillbirth rate in the UK was 4.2 per 1000 live births, ranking 24th out of 49 high-income countries, with an annual rate of reduction of only 1.4% per year. The majority of stillbirths occur in normally formed infants, with (retrospective) evidence of placental insufficiency the most common clinical finding. Maternal perception of reduced fetal movements (RFM) is associated with placental insufficiency and increased risk of subsequent stillbirth.This study will test the hypothesis that the introduction of a package of care to increase women's awareness of the need for prompt reporting of RFM and standardised management to identify fetal compromise with timely delivery in confirmed cases, will reduce the rate of stillbirth. Following the introduction of a similar intervention in Norway the odds of stillbirth fell by 30%, but the efficacy of this intervention (and possible adverse effects and implications for service delivery) has not been tested in a randomised trial. METHODS: We describe a stepped-wedge cluster trial design, in which participating hospitals in the UK and Ireland will be randomised to the timing of introduction of the care package. Outcomes (including the primary outcome of stillbirth) will be derived from detailed routinely collected maternity data, allowing us to robustly test our hypothesis. The degree of implementation of the intervention will be assessed in each site. A nested qualitative study will examine the acceptability of the intervention to women and healthcare providers and identify process issues including barriers to implementation. ETHICS AND DISSEMINATION: Ethical approval was obtained from the Scotland A Research Ethics Committee (Ref 13/SS/0001) and from Research and Development offices in participating maternity units. The study started in February 2014 and delivery of the intervention completed in December 2016. Results of the study will be submitted for publication in peer-reviewed journals and disseminated to local investigating sites to inform education and care of women presenting with RFM. TRIAL REGISTRATION NUMBER: www.clinicaltrials.gov NCT01777022. VERSION: Protocol Version 4.2, 3 February 2017.

Antenatal care trial interventions: a systematic scoping review and taxonomy development of care models.

BACKGROUND: Antenatal care models vary widely around the world, reflecting local contexts, drivers and resources. Randomised controlled trials (RCTs) have tested the impact of multi-component antenatal care interventions on service delivery and outcomes in many countries since the 1980s. Some have applied entirely new schemes, while others have modified existing care delivery approaches. Systematic reviews (SRs) indicate that some specific antenatal interventions are more effective than others; however the causal mechanisms leading to better outcomes are poorly understood, limiting implementation and future research. As a first step in identifying what might be making the difference we conducted a scoping review of interventions tested in RCTs in order to establish a taxonomy of antenatal care models. METHODS: A protocol-driven systematic search was undertaken of databases for RCTs and SRs reporting antenatal care interventions. Results were unrestricted by time or locality, but limited to English language. Key characteristics of both experimental and control interventions in the included trials were mapped using SPIO (Study design; Population; Intervention; Outcomes) criteria and the intervention and principal outcome measures were described. Commonalities and differences between the components that were being tested in each study were identified by consensus, resulting in a comprehensive description of emergent models for antenatal care interventions. RESULTS: Of 13,050 articles retrieved, we identified 153 eligible articles including 130 RCTs in 34 countries. The interventions tested in these trials varied from the number of visits to the location of care provision, and from the content of care to the professional/lay group providing that care. In most studies neither intervention nor control arm was well described. Our analysis of the identified trials of antenatal care interventions produced the following taxonomy: Universal provision model (for all women irrespective of health state or complications); Restricted 'lower-risk'-based provision model (midwifery-led or reduced/flexible visit approach for healthy women); Augmented provision model (antenatal care as in Universal provision above but augmented by clinical, educational or behavioural intervention); Targeted 'higher-risk'-based provision model (for woman with defined clinical or socio-demographic risk factors). The first category was most commonly tested in low-income countries (i.e. resource-poor settings), particularly in Asia. The other categories were tested around the world. The trials included a range of care providers, including midwives, nurses, doctors, and lay workers. CONCLUSIONS: Interventions can be defined and described in many ways. The intended antenatal care population group proved the simplest and most clinically relevant way of distinguishing trials which might otherwise be categorised together. Since our review excluded non-trial interventions, the taxonomy does not represent antenatal care provision worldwide. It offers a stable and reproducible approach to describing the purpose and content of models of antenatal care which have been tested in a trial. It highlights a lack of reported detail of trial interventions and usual care processes. It provides a baseline for future work to examine and test the salient characteristics of the most effective models, and could also help decision-makers and service planners in planning implementation.

Midwifery-led antenatal care models: mapping a systematic review to an evidence-based quality framework to identify key components and characteristics of care.

BACKGROUND: Implementing effective antenatal care models is a key global policy goal. However, the mechanisms of action of these multi-faceted models that would allow widespread implementation are seldom examined and poorly understood. In existing care model analyses there is little distinction between what is done, how it is done, and who does it. A new evidence-informed quality maternal and newborn care (QMNC) framework identifies key characteristics of quality care. This offers the opportunity to identify systematically the characteristics of care delivery that may be generalizable across contexts, thereby enhancing implementation. Our objective was to map the characteristics of antenatal care models tested in Randomised Controlled Trials (RCTs) to a new evidence-based framework for quality maternal and newborn care; thus facilitating the identification of characteristics of effective care. METHODS: A systematic review of RCTs of midwifery-led antenatal care models. Mapping and evaluation of these models' characteristics to the QMNC framework using data extraction and scoring forms derived from the five framework components. Paired team members independently extracted data and conducted quality assessment using the QMNC framework and standard RCT criteria. RESULTS: From 13,050 citations initially retrieved we identified 17 RCTs of midwifery-led antenatal care models from Australia (7), the UK (4), China (2), and Sweden, Ireland, Mexico and Canada (1 each). QMNC framework scores ranged from 9 to 25 (possible range 0-32), with most models reporting fewer than half the characteristics associated with quality maternity care. Description of care model characteristics was lacking in many studies, but was better reported for the intervention arms. Organisation of care was the best-described component. Underlying values and philosophy of care were poorly reported. CONCLUSIONS: The QMNC framework facilitates assessment of the characteristics of antenatal care models. It is vital to understand all the characteristics of multi-faceted interventions such as care models; not only what is done but why it is done, by whom, and how this differed from the standard care package. By applying the QMNC framework we have established a foundation for future reports of intervention studies so that the characteristics of individual models can be evaluated, and the impact of any differences appraised.

Midwifery support in labour: how important is it to stay in the room?

This paper draws on the findings of an observational study of intrapartum care in Scotland, UK. Observations lasting up to three hours were undertaken of 49 labour episodes. Quantitative data gathered through the study identified associations between women's feelings about the support they received and the proportion of time that their midwife was present in the labour room and between the midwife's presence and the type of birth. Reflections on the care observed during the 104 hours of observations identified several key consequences of the midwife's absence from the room: heightened anxiety of the woman and her birth partner; a reduction in opportunities to build rapport and offer support; and a reduction in the midwife's ability to monitor the progress of the labour accurately. The study also found that those midwives who were out of the room more, were less supportive of the women in their care when they were in the room.

Measuring the quality and quantity of professional intrapartum support: testing a computerised systematic observation tool in the clinical setting.

BACKGROUND: Continuous support in labour has a significant impact on a range of clinical outcomes, though whether the quality and quantity of support behaviours affects the strength of this impact has not yet been established. To identify the quality and quantity of support, a reliable means of measurement is needed. To this end, a new computerised systematic observation tool, the 'SMILI' (Supportive Midwifery in Labour Instrument) was developed.The aim of the study was to test the validity and usability of the 'Supportive Midwifery in Labour Instrument' (SMILI) and to test the feasibility and acceptability of the systematic observation approach in the clinical intrapartum setting. METHODS: Systematic observation was combined with a postnatal questionnaire and the collection of data about clinical processes and outcomes for each observed labour.The setting for the study was four National Health Service maternity units in Scotland, UK. Participants in this study were forty five midwives and forty four women.The SMILI was used by trained midwife observers to record labour care provided by midwives. Observations were undertaken for an average of two hours and seventeen minutes during the active first stage of labour and, in 18 cases, the observation included the second stage of labour. Content validity of the instrument was tested by the observers, noting the extent to which the SMILI facilitated the recording of all key aspects of labour care and interactions. Construct validity was tested through exploration of correlations between the data recorded and women's feelings about the support they received. Feasibility and usability data were recorded following each observation by the observer. Internal reliability and construct validity were tested through statistical analysis of the data. RESULTS: One hundred and four hours of labour care were observed and recorded using the SMILI during forty nine labour episodes. CONCLUSION: The SMILI was found to be a valid and reliable instrument in the intrapartum setting in which it was tested. The study identified that the SMILI could be used to test correlations between the quantity and quality of support and outcomes. The systematic observational approach was found to be an acceptable and feasible method of enquiry.

An audit of pregnant women with severe mental illness referred during the first 2 years of a new perinatal mental health service.

The importance of identifying pregnant women at high risk of postpartum psychotic illness has been highlighted by recent enquiries and guidelines. It has been recommended that these women are referred to perinatal mental health services, and that individualised care plans are made prior to delivery. This audit describes a cohort of 45 women, referred to a new perinatal mental health service, with a history of psychotic illness or at risk of developing a postpartum psychotic episode. It describes the characteristics of this group, and the outcomes in terms of relapse and whether their children remained in their care. Thirty-nine women (87%) were seen for assessment. Sixty-seven per cent were under the care of a community mental health team. Twenty-one (53.8%) were well at the time of referral. Planned pregnancies were uncommon (15%). All women seen antenatally had care plans written to address the high risk of postpartum relapse. Ten (26%) women had psychiatric admissions during pregnancy. Fifteen (38%) relapsed or had admissions during the first postpartum year. At 1 year postpartum, 74% women had care of their children; 18% children had been adopted or were in foster care; and the outcome was unknown for 8%.