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

Abstract

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.

Group antenatal care: findings from a pilot randomised controlled trial of REACH Pregnancy Circles

“…Additional aims were to assess the utility of the proposed outcome measures for the main trial and the economic evaluation. The assessment of the suitability of primary outcome measure (spontaneous vaginal birth) was achieved; it was found to be feasible, but subsequently it was necessary to replace this in the main trial at the request of the ethics committee (25). Furthermore, the development for the economic evaluation of a composite measure of a 'positive healthy birth' was initiated with the identi cation of what individuals think is important in order to achieve a positive pregnancy, birth and post-natal experience.…”

“…The intention had been to run the full trial in the same single NHS trust where the pilot was conducted. In fact, the full trial is now running in multiple NHS trusts both in and outside of London (25). This was because during the pilot it was recognised that it would not be possible to incorporate Pregnancy Circles within a single maternity service at the scale required to run the full trial.…”

Ann Oakley: new learning and global influence from working across conventional boundaries

“…A study spanning similar boundaries replicated the social support for disadvantaged women with new babies, with the midwives replaced by health visitors (Wiggins et al, 2004). Subsequent randomised controlled trials integrated both process and economic evaluations (Christie et al, 2014;Wiggins et al, 2020).…”

Group Care in the first 1000 days: implementation and process evaluation of contextually adapted antenatal and postnatal group care targeting diverse vulnerable populations in high-, middle- and low-resource settings

“…Rooted in critical realism, it has an explanatory focus that aims to understand how the implementation of programmes are shaped, enabled and constrained by the interaction between programme elements (e. propositions that will be examined in this evaluation. The model is derived from the prior work of (author and colleagues) in development of the Pregnancy Circles trial in the UK [47].…”