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

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.

Infection and wound breakdown in spontaneous second-degree perineal tears: An exploratory mixed methods study.

BACKGROUND: Perineal trauma affects large numbers of women who have a vaginal birth. This study explores the incidence, etiology and women's experiences of wound infection/breakdown associated with spontaneous second degree tears. METHODS: This was an exploratory mixed methods study set in an urban tertiary National Health Service hospital in 2014-2015. The study included a prospective observational study of second-degree tears using electronic patient records. Infection was defined using criteria adapted from Public Health England's Surgical Site Infection Surveillance Service. We also did a case-control study of maternity records to explore factors associated with perineal infection/wound breakdown, and semi-structured interviews with a purposeful sample of women who experienced wound infection/breakdown. RESULTS: Of 2892 vaginal births during the study period, 76.8% sustained perineal trauma, with second-degree tears most commonly recorded (n = 828/28.6%). Sixteen (1.9%) had a documented infection/wound breakdown which were associated with "compromised wound status" (increased severity of wound/poor suturing; P = 0.033) Women complained of a lack of information about their perineum and poor postnatal surveillance by midwives and physicians. Diagnosis and treatment were often delayed by clinicians' reliance on external signs of wound infection. Although the sample size was small, there were no differences in rates of infection between sutured and unsutured second-degree tears. CONCLUSIONS: Although second-degree tears were common after vaginal birth, wound infection/breakdown was relatively uncommon. Women who report feeling unwell or develop pyrexia postnatally should be assessed urgently. A prospective longitudinal study exploring the long-term sequelae of second-degree tears is needed.

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

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.

Better together: A qualitative exploration of women's perceptions and experiences of group antenatal care.

PROBLEM: Childbearing women from socio-economically disadvantaged communities and minority ethnic groups are less likely to access antenatal care and experience more adverse pregnancy outcomes. BACKGROUND: Group antenatal care aims to facilitate information sharing and social support. It is associated with higher rates of attendance and improved health outcomes. AIMS: To assess the acceptability of a bespoke model of group antenatal care (Pregnancy Circles) in an inner city community in England, understand how the model affects women's experiences of pregnancy and antenatal care, and inform further development and testing of the model. METHODS: A two-stage qualitative study comprising focus groups with twenty six local women, followed by the implementation of four Pregnancy Circles attended by twenty four women, which were evaluated using observations, focus groups and semi-structured interviews with participants. Data were analysed thematically. FINDINGS: Pregnancy Circles offered an appealing alternative to standard antenatal care and functioned as an instrument of empowerment, mediated through increased learning and knowledge sharing, active participation in care and peer and professional relationship building. Multiparous women and women from diverse cultures sharing their experiences during Circle sessions was particularly valued. Participants had mixed views about including partners in the sessions. CONCLUSIONS: Group antenatal care, in the form of Pregnancy Circles, is acceptable to women and appears to enhance their experiences of pregnancy. Further work needs to be done both to test the findings in larger, quantitative studies and to find a model of care that is acceptable to women and their partners.

`It makes sense and it works': Maternity care providers' perspectives on the feasibility of a group antenatal care model (Pregnancy Circles).

AIM: To test the feasibility of introducing a group antenatal care initiative (Pregnancy Circles) in an area with high levels of social deprivation and cultural diversity by exploring the views and experiences of midwives and other maternity care providers in the locality before and after the implementation of a test run of the group model. DESIGN: (i) Pre-implementation semi-structured interviews with local stakeholders. (ii) Post-implementation informal and semi-structured interviews and a reflective workshop with facilitating midwives, and semi-structured interviews with maternity managers and commissioners. Data were organised around three core themes of organisational readiness, the acceptability of the model, and its impact on midwifery practice, and analyzed thematically. SETTING: A large inner-city National Health Service Trust in the United Kingdom. PARTICIPANTS: Sixteen stakeholders were interviewed prior to, and ten after, the group model was implemented. Feedback was also obtained from a further nine midwives and one student midwife who facilitated the Pregnancy Circles. INTERVENTION: Four Pregnancy Circles in community settings. Women with pregnancies of similar gestation were brought together for antenatal care incorporating information sharing and peer support. Women undertook their own blood pressure and urine checks, and had brief individual midwifery checks in the group space. FINDINGS: Dissatisfaction with current practice fuelled organisational readiness and the intervention was both possible and acceptable in the host setting. A perceived lack of privacy in a group setting, the ramifications of devolving blood pressure and urine checks to women, and the involvement of partners in sessions were identified as sticking points. Facilitating midwives need to be adequately supported and trained in group facilitation. Midwives derived accomplishment and job satisfaction from working in this way, and considered that it empowered women and enhanced care. KEY CONCLUSIONS: Participants reported widespread dissatisfaction with current care provision. Pregnancy Circles were experienced as a safe environment in which to provide care, and one that enabled midwives to build meaningful relationships with women. IMPLICATIONS FOR PRACTICE: Pre-registration education inadequately prepared midwives for group care. Addressing sticking points and securing management support for Pregnancy Circles is vital to sustain participation in this model of care.

Testing the effectiveness of REACH Pregnancy Circles group antenatal care: protocol for a randomised controlled pilot trial.

BACKGROUND: Antenatal care is an important public health priority. Women from socially disadvantaged, and culturally and linguistically diverse groups often have difficulties with accessing antenatal care and report more negative experiences with care. Although group antenatal care has been shown in some settings to be effective for improving women's experiences of care and for improving other maternal as well as newborn health outcomes, these outcomes have not been rigorously assessed in the UK. A pilot trial will be conducted to determine the feasibility of, and optimum methods for, testing the effectiveness of group antenatal care in an NHS setting serving populations with high levels of social deprivation and cultural, linguistic and ethnic diversity. Outcomes will inform the protocol for a future full trial. METHODS: This protocol outlines an individual-level randomised controlled external pilot trial with integrated process and economic evaluations. The two trial arms will be group care and standard antenatal care. The trial will involve the recruitment of 72 pregnant women across three maternity services within one large NHS Acute Trust. Baseline, outcomes and economic data will be collected via questionnaires completed by the participants at three time points, with the final scheduled for 4 months postnatal. Routine maternity service data will also be collected for outcomes assessment and economic evaluation purposes. Stakeholder interviews will provide insights into the acceptability of research and intervention processes, including the use of interpreters to support women who do not speak English. Pre-agreed criteria have been selected to guide the decision about whether or not to progress to a full trial. DISCUSSION: This pilot trial will determine if it is appropriate to proceed to a full trial of group antenatal care in this setting. If progression is supported, the pilot will provide authoritative high-quality evidence to inform the design and conduct of a trial in this important area that holds significant potential to influence maternity care, outcomes and experience. TRIAL REGISTRATION: ISRCTN ISRCTN66925258. Registered 03 April 2017. Retrospectively registered.