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

Article


Wiggins, M., Sawtell, M., Wiseman, O., McCourt, C., Eldridge, S., Hunter, R., Bordea, E., Mustard, C., Hanafiah, A., Hatherall, B., Holmes, V., Mehay, A., Robinson, H., Salisbury, C., Sweeney, L., Mondeh, K. and Harden, A. 2020. Group antenatal care (Pregnancy Circles) for diverse and disadvantaged women: study protocol for a randomised controlled trial with integral process and economic evaluations. BMC Health Services Research. 20 (Art. 919). https://doi.org/10.1186/s12913-020-05751-z
AuthorsWiggins, M., Sawtell, M., Wiseman, O., McCourt, C., Eldridge, S., Hunter, R., Bordea, E., Mustard, C., Hanafiah, A., Hatherall, B., Holmes, V., Mehay, A., Robinson, H., Salisbury, C., Sweeney, L., Mondeh, K. and Harden, A.
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.

JournalBMC Health Services Research
Journal citation20 (Art. 919)
ISSN1472-6963
Year2020
PublisherBMC
Publisher's version
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Anyone
Digital Object Identifier (DOI)https://doi.org/10.1186/s12913-020-05751-z
Publication dates
Online07 Oct 2020
Publication process dates
Accepted21 Sep 2020
Deposited12 Oct 2020
FunderNational Institute for Health Research
Copyright holder© 2020 The Authors
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