Group antenatal care (Pregnancy Circles) for diverse and disadvantaged women: study protocol for a randomised controlled trial with integral process and economic evaluations.

BACKGROUND: Group antenatal care has been successfully implemented around the world with suggestions of improved outcomes, including for disadvantaged groups, but it has not been formally tested in the UK in the context of the NHS. To address this the REACH Pregnancy Circles intervention was developed and a randomised controlled trial (RCT), based on a pilot study, is in progress. METHODS: The RCT is a pragmatic, two-arm, individually randomised, parallel group RCT designed to test clinical and cost-effectiveness of REACH Pregnancy Circles compared with standard care. Recruitment will be through NHS services. The sample size is 1732 (866 randomised to the intervention and 866 to standard care). The primary outcome measure is a 'healthy baby' composite measured at 1 month postnatal using routine maternity data. Secondary outcome measures will be assessed using participant questionnaires completed at recruitment (baseline), 35 weeks gestation (follow-up 1) and 3 months postnatal (follow-up 2). An integrated process evaluation, to include exploration of fidelity, will be conducted using mixed methods. Analyses will be on an intention to treat as allocated basis. The primary analysis will compare the number of babies born "healthy" in the control and intervention arms and provide an odds ratio. A cost-effectiveness analysis will compare the incremental cost per Quality Adjusted Life Years and per additional 'healthy and positive birth' of the intervention with standard care. Qualitative data will be analysed thematically. DISCUSSION: This multi-site randomised trial in England is planned to be the largest trial of group antenatal care in the world to date; as well as the first rigorous test within the NHS of this maternity service change. It has a recruitment focus on ethnically, culturally and linguistically diverse and disadvantaged participants, including non-English speakers. TRIAL REGISTRATION: Trial registration; ISRCTN, ISRCTN91977441 . Registered 11 February 2019 - retrospectively registered. The current protocol is Version 4; 28/01/2020.

Timing of the initiation of antenatal care: An exploratory qualitative study of women and service providers in East London.

OBJECTIVE: to explore the factors which influence the timing of the initiation of a package of publically-funded antenatal care for pregnant women living in a diverse urban setting DESIGN: a qualitative study involving thematic analysis of 21 individual interviews and six focus group discussions. SETTING: Newham, a culturally diverse borough in East London, UK PARTICIPANTS: individual interviews were conducted with 21 pregnant and postnatal women and focus group discussions were conducted with a total of 26 health service staff members(midwives and bilingual health advocates) and 32 women from four community groups (Bangladeshi, Somali, Lithuanian and Polish). FINDINGS: initial care-seeking by pregnant women is influenced by the perception that the package of antenatal care offered by the National Health Service is for viable and continuing pregnancies, as well as little perceived urgency in initiating antenatal care. This is particularly true when set against competing responsibilities and commitments in women's lives and for pregnancies with no apparent complications or disconcerting symptoms. Barriers to access to this package of antenatal care include difficulties in navigating the health service and referral system, which are compounded for women unable to speak English, and service provider delays in the processing of referrals. Accessing antenatal care was sometimes equated with relinquishing control, particularly for young women and women for whom language barriers prohibit active engagement with care. CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: if women are to be encouraged to seek antenatal care from maternity services early in pregnancy, the purpose and value to all women of doing so need to be made clear across the communities in which they live. As a woman may need time to accept her pregnancy and address other priorities in her life before seeking antenatal care, it is crucial that once she does decide to seek such care, access is quick and easy. Difficulties found in navigating the system of referral for antenatal care point to a need for improved access to primary care and a simple and efficient process of direct referral to antenatal care, alongside the delivery of antenatal care which is woman-centred and experienced as empowering.