Sawtell Mary, Wiggins Meg, Wiseman Octavia, Mehay Anita, McCourt Christine, Sweeney Lorna, Hatherall Bethan, Ahmed Tahania, Greenberg Lauren, Hunter Rachael, Hamborg Thomas, Eldridge Sandra, Harden Angela
Institute of Education, University College London, London, UK.
School of Health Sciences, City University of London, London, UK.
Pilot Feasibility Stud. 2023 Mar 16;9(1):42. doi: 10.1186/s40814-023-01238-w.
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.
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.
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.
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.
ISRCTN ISRCTN66925258. Retrospectively registered, 03 April 2017.
产前护理有可能对母婴结局产生积极影响,但英国传统的护理模式已显示出存在局限性,尤其是对那些来自贫困人群的产妇。小组产前护理是传统个体护理的替代模式。它将产前评估的常规内容与小组讨论及支持相结合。在各个国家,小组产前护理的实施已被证明是成功的;目前英国需要进行一项正式试验。
在伦敦市中心的一家国民保健服务信托机构中,针对在为贫困和多样化程度高的人群提供服务的国民保健服务环境中实施的一种小组护理模式(孕期交流圈)开展了一项个体随机对照试验(RCT)。这是一项针对一项潜在的具备完整经济评估的全面RCT的外部预试验研究。该预试验旨在探索全面试验方法的可行性。纳入标准包括预产期在一定范围内、年龄16岁及以上且居住在特定地理区域内的孕妇。对数据进行了分析,以评估其在全面试验中的完整性和可用性;未对结局指标的组间差异进行假设检验。设定了与五项可行性指标相对应的预先指定的进展标准。额外的目标是评估我们提议的结局指标和不同数据收集途径的效用。利用访谈和观察进行了过程评估。
74名参与者被随机分组,比预先设定的目标多2人。共开展了三个孕期交流圈,每个交流圈有八次活动。对十名孕妇参与者、七名助产士和四名其他利益相关者进行了访谈;对两次干预活动进行了观察。所有五项指标的进展标准均达到了足够水平:可获得的招募人数、招募率、干预参与率和留存率以及问卷完成率。结局指标评估显示出可行性和足够的完成率;已启动对“积极健康分娩”的经济评估综合指标的制定。
我们的预试验结果表明,进行一项全面的随机对照试验是可行的,但需要在招募流程、语言支持、干预场所的可达性和结局评估方面进行一些调整。
ISRCTN ISRCTN66925258。追溯注册于2017年4月3日。