Abstract
BackgroundGroup 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.MethodsThe 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.DiscussionThis 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 registrationTrial registration; ISRCTN, ISRCTN91977441. Registered 11 February 2019 - retrospectively registered. The current protocol is Version 4; 28/01/2020.
Highlights
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 National Health Service (NHS)
Wiggins et al BMC Health Services Research (2020) 20:919 (Continued from previous page). 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
The Research for Equitable Antenatal Care and Health (REACH) Pregnancy Circles trial aims to assess the following in ethnically, culturally and linguistically diverse and disadvantaged areas of the UK: a) Whether Pregnancy Circles improves the health of babies compared with the standard individual model of antenatal care b) Whether attending Pregnancy Circles improves maternal outcomes such as empowerment and post-natal psychological wellbeing, as well as increasing women’s satisfaction with antenatal care c) Cost-effectiveness, intervention mechanisms and acceptability of Pregnancy Circles care to women and staff and issues relevant to future sustainability and wider implementation in the NHS
Summary
Aims The REACH Pregnancy Circles trial aims to assess the following in ethnically, culturally and linguistically diverse and disadvantaged areas of the UK: a) Whether Pregnancy Circles (group-based antenatal care) improves the health of babies compared with the standard individual model of antenatal care b) Whether attending Pregnancy Circles improves maternal outcomes such as empowerment and post-natal psychological wellbeing, as well as increasing women’s satisfaction with antenatal care c) Cost-effectiveness, intervention mechanisms and acceptability of Pregnancy Circles care to women and staff and issues relevant to future sustainability and wider implementation in the NHS. The economic evaluation used participant questionnaires to explore additional utility measures Building on this in this trial, women will be involved in defining what a ‘positive and healthy pregnancy and birth’ is, to enable a calculation of the incremental cost per additional ‘healthy birth’ for Pregnancy Circles compared to standard care, using a new composite measure. In the case study sites, a purposive sample of midwives and key stakeholders (other relevant staff, recruiters, clinical commissioners and patient group representatives) will be offered the opportunity to take part in a brief one to one or paired interview These will explore perceptions of issues such as delivery of Pregnancy Circles, retention in the groups, sustainability of this model of care, and potential control group contamination. This is relevant in trials of interventions, such as this one, which have a low risk profile
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
