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

Abstract

Background Antenatal care has the potential to impact positively on maternal and child outcomes, but traditional models of care in the UK have been shown to have limitations and particularly for those from deprived populations. Group antenatal care is an alternative model to traditional individual care. It combines conventional aspects of antenatal assessment with group discussion and support. Delivery of group antenatal care has been shown to be successful in various countries; there is now a need for a formal trial in the UK. Method An individual randomised controlled trial (RCT) of a model of group care (Pregnancy Circles) delivered in NHS settings serving populations with high levels of deprivation and diversity was conducted in an inner London NHS trust. This was an external pilot study for a potential fully powered RCT with integral economic evaluation. The pilot aimed to explore the feasibility of methods for the full trial. Inclusion criteria included pregnant with a due date in a certain range, 16 + years and living within specified geographic areas. Data were analysed for completeness and usability in a full trial; no hypothesis testing for between-group differences in outcome measures was undertaken. Pre-specified progression criteria corresponding to five feasibility measures were set. Additional aims were to assess the utility of our proposed outcome measures and different data collection routes. A process evaluation utilising interviews and observations was conducted. Results Seventy-four participants were randomised, two more than the a priori target. Three Pregnancy Circles of eight sessions each were run. Interviews were undertaken with ten pregnant participants, seven midwives and four other stakeholders; two observations of intervention sessions were conducted. Progression criteria were met at sufficient levels for all five measures: available recruitment numbers, recruitment rate, intervention uptake and retention and questionnaire completion rates. Outcome measure assessments showed feasibility and sufficient completion rates; the development of an economic evaluation composite measure of a ‘positive healthy birth’ was initiated. Conclusion Our pilot findings indicate that a full RCT would be feasible to conduct with a few adjustments related to recruitment processes, language support, accessibility of intervention premises and outcome assessment. Trial registration ISRCTN ISRCTN66925258. Retrospectively registered, 03 April 2017.

Exploring the feasibility of conducting a randomised controlled trial of group-based pregnancy care and education: a pilot randomised controlled trial in Melbourne, Australia

“…Our pilot RCT of Group Care addressed all our study aims and demonstrated feasibility for a larger RCT, and acceptability for women and midwives. Thirty-five percent of women approached agreed to participate, very similar to other successful studies from our team [ 25 ] and to a recent pilot RCT of Group Care in the UK [ 26 ]. No woman declined participation because she would be randomised, and none declined because other women’s partners would be present in the group setting.…”

“…Recruitment to the current UK RCT [ 14 ] was paused in 2020, with women already recruited and allocated to group care returned to having one-to-one care, but where possible group elements for some participants were retained, and a number of the sites reported successfully implementing the group care model online [ 9 , 14 ]. This followed the group’s successful pilot RCT which was very similar to our own [ 26 ]. The research team recommenced recruitment in May 2022 with maximum flexibility between in person care and remote elements as required, and continuing to recruit in July 2023 (Christine McCourt, personal communication, May 2022, July 2023).…”

“…The women allocated to the Group Care intervention were very satisfied with the care they received in the group setting, and happy with the information provision, consistent with the Cochrane Review [ 3 ], and the pilot study of the UK RCT [ 14 , 26 ], where the model was acceptable to women and enhanced their experiences [ 27 ]. Just under half attended all six 2-h sessions, slightly higher than the recent UK pilot, where 37% attended six or more sessions (although that was in a context of eight group sessions) [ 26 ]. Of the remainder, most (94%) missed only one or two sessions, with the main reasons being ill-health or birth of the baby prior to the final session, and we do not expect that this is very different from women attending maternity care generally.…”

What are the mechanisms of effect of group antenatal care? A systematic realist review and synthesis of the literature

“…The findings of both studies were utilised to develop a logic and core values model for the trial intervention (see Figure 2 and Figure 3). An RCT with nested qualitative evaluation is currently in progress [28], following a successful pilot trial [77].…”

Ethnic inequities in maternal health

“…The observatory review identified only 19 evaluated interventions over 40 years, and methodological limitations created difficulties in assessing their impact 7. Several ongoing initiatives, such as pregnancy circles (group antenatal care targeted at women living in deprived and ethnically diverse parts of England910) are yet to report results 7. Consequently, the effectiveness of most existing interventions remains unclear.…”