Abstract
BackgroundThe provision of high-quality maternity services is a priority for reducing inequalities in health outcomes for mothers and infants. Best practice includes women having their initial antenatal appointment within the first trimester of pregnancy in order to provide screening and support for healthy lifestyles, well-being and self-care in pregnancy. Previous research has identified inequalities in access to antenatal care, yet there is little evidence on interventions to improve early initiation of antenatal care. The Community REACH trial will assess the effectiveness and cost-effectiveness of engaging communities in the co-production and delivery of an intervention that addresses this issue.Methods/designThe study design is a matched cluster randomised controlled trial with integrated process and economic evaluations. The unit of randomisation is electoral ward. The intervention will be delivered in 10 wards; 10 comparator wards will have normal practice. The primary outcome is the proportion of pregnant women attending their antenatal booking appointment by the 12th completed week of pregnancy. This and a number of secondary outcomes will be assessed for cohorts of women (n = approximately 1450 per arm) who give birth 2–7 and 8–13 months after intervention delivery completion in the included wards, using routinely collected maternity data. Eight hospitals commissioned to provide maternity services in six NHS trusts in north and east London and Essex have been recruited to the study. These trusts will provide anonymised routine data for randomisation and outcomes analysis. The process evaluation will examine intervention implementation, acceptability, reach and possible causal pathways. The economic evaluation will use a cost-consequences analysis and decision model to evaluate the intervention. Targeted community engagement in the research process was a priority.DiscussionCommunity REACH aims to increase early initiation of antenatal care using an intervention that is co-produced and delivered by local communities. This pragmatic cluster randomised controlled trial, with integrated process and economic evaluation, aims to rigorously assess the effectiveness of this public health intervention, which is particularly complex due to the required combination of standardisation with local flexibility. It will also answer questions about scalability and generalisability.Trial registrationISRCTN registry: registration number 63066975. Registered on 18 August 2015.
Highlights
The provision of high-quality maternity services is a priority for reducing inequalities in health outcomes for mothers and infants
Current national guidelines recommend that women have a first contact followed by an antenatal care booking appointment with a maternity service within the first trimester of pregnancy, in order to fully benefit from the available screening, interventions and support [5]
This paper presents the study protocol for the first cluster randomised controlled trial of a community-centred intervention that seeks to increase early initiation of antenatal care in communities where women are more likely to experience late initiation of antenatal care
Summary
The provision of high-quality maternity services is a priority for reducing inequalities in health outcomes for mothers and infants. Best practice includes women having their initial antenatal appointment within the first trimester of pregnancy in order to provide screening and support for healthy lifestyles, well-being and self-care in pregnancy. In the UK the provision of highquality maternity services is a priority for reducing national inequalities in health outcomes throughout pregnancy, birth and the subsequent life course of the mother and infant [1]. Current national guidelines recommend that women have a first contact (with a midwife or GP) followed by an antenatal care booking appointment with a maternity service within the first trimester of pregnancy (and ideally by 10 weeks), in order to fully benefit from the available screening, interventions and support [5]. The booking appointment is important for identifying women with social and medical risk factors so that these can be appropriately managed throughout the maternity pathway [6]
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