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
The study aimed to explore optimum methods for testing the effectiveness of a model of group care (Pregnancy Circles) in NHS-settings serving populations with high levels of deprivation and diversity. An individual randomised controlled trial (RCT) was conducted in an inner London NHS trust as an external pilot for a potential fully-powered RCT with integral economic evaluation. Inclusion criteria included: pregnant with 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 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, questionnaire completion rates. Outcome measure assessments showed feasibility and sufficient completion rates; 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.