Title: Planning mode of birth in routine Antenatal care – development of a decision-aid (Plan-A)
Funder: Chief Scientist Office, Scotland

Abstract: Aim: This work will develop a decision aid to support pregnant women to choose between planning vaginal or caesarean birth during antenatal discussions with health professionals. Background: Childbirth is a safe and positive experience for most women in the UK, but it often involves input from doctors, e.g. to do an unplanned caesarean section. This can be difficult for women who were not expecting help to give birth or unaware of the possible risks. Equally, some women may feel that they should have had help when they did not. These issues can lead to disappointment, and physical or mental health problems, particularly in women from minority and under-served groups. Aiming for a vaginal birth or having a planned caesarean birth each have potential benefits and harms. Both are reasonable options, and for 10 years national guidance has stated that the risks and benefits of each should be discussed with women during pregnancy to help plan their birth. Legal changes in 2015 made this essential. However, with no guidance or resources to support these discussions between maternity staff and pregnant women, they do not happen consistently, if at all. Highlighting the importance of this, maternity services reported a £2 billion compensation bill in 2018/19, with lack of informed consent and failure to offer a caesarean birth listed as key reasons. Decision aids are tools that can help maternity staff have balanced conversations with women about their birth plan options. They provide a framework for discussions and can increase knowledge, support choice, and reduce regret. Currently, no decision aid exists for planning how to give birth in routine maternity care. We will address this. Methods: Following expert guidance on developing a decision aid, we will 1) review published scientific evidence and 2) interview doctors, midwives, pregnant women and parents. This will allow us to understand how decisions about birth plans are made, influences on these decisions, what a decision aid should look like (e.g. how best to access, what it should contain) and when to use it in pregnancy. We will survey pregnant women, parents and healthcare staff to identify which outcomes of planned vaginal or caesarean birth are important to know about in advance. We will use these findings to develop a decision aid that will be tested and revised during workshops with women, doctors and midwives. It will then be tested in real-life in five UK maternity units. The testing will assess how women, midwives and doctors value it and will help us understand how best to embed it in the NHS. We will write a plan for how the NHS should adapt to support all women to use the decision aid. We will also consider the financial costs and benefits of using the decision aid. Our research team includes women, midwives, maternity doctors, and researchers. Patient and public involvement: We spoke to eight women about our ideas in 2018 and with four representatives of women’s birth-related support groups in a workshop in 2019. Their input drove the study plans. Four women with different pregnancy and birth experiences, and representation of other women’s views, are part of the research team. Four more women will join them to form a panel to help develop the decision aid and share the findings. Dissemination: We will share the decision aid and our plan for embedding it in the NHS with maternity units, policymakers and the public via professional and public networks.

Lay abstract: Research question: What should a decision aid (DA) to support antenatal conversations on mode of birth plans between pregnant women and health professionals look like, how should it be embedded in practice and what may the resource implications of its use be? Background: Pregnant women are not currently offered adequate support to make informed choices between planning vaginal (VB) or caesarean birth (CB) in UK antenatal care, despite national guidance recommending this since 2011, and legal precedent demanding this since 2015. Aim: To develop a DA to support conversations between pregnant women (+/- their partners) and health professionals on the options of planned CB and planned VB in routine antenatal care; to generate a strategy for NHS implementation; and to explore potential costs/savings with its use. Methods: The project will adopt established DA development methodology across six work packages (WPs). A patient and public involvement (PPI) panel will work with the research team (including 7 maternity health professionals) to develop the DA. Systematic reviews of published evidence (WP1) will identify 1) pregnant women’s information needs when planning birth mode 2) influences on women’s preferences for planned VB or CB 3) experiences of minority and under-served women in NHS antenatal care. The findings will shape WP2 (qualitative interviews), WP3 (DA content prioritisation) and WP4 (DA development). The qualitative interview study (WP2) will include parents and prospective parents, GPs, obstetricians and midwives. It will inform the DA scope, content, format and timing of use, and by identifying potential barriers and facilitators of the DA use, will inform the implementation strategy development. A consensus process (WP3) - a 2-round Delphi electronic survey and a virtual consensus meeting - will ensure that stakeholders shape the DA content by prioritising the order and format in which outcomes of planned VB or CB are presented. The initial DA will be developed (WP4) with WP1-3 findings using storyboarding techniques. The DA - likely electronic, web-based but downloadable – will highlight the choice, its attributes, key issues for specific groups of women, and how to incorporate individual values in the decision. Online and in-person stakeholder workshops will refine the DA. The DA will be field-tested (WP5) to assess acceptability, then refined. Pregnant women and health professionals will provide verbal feedback on their use of the DA in five UK sites, and a sample of uses will be observed. Barriers and facilitators of its use will inform the implementation strategy using the Theoretical Domains Framework. Resource use data will inform the adaptation of existing economic models (WP6) to assess the resource impact of the DA use. Recruitment will be inclusive and targeted to ensure minority groups and under-served women are heard. Timeline Month 0-2: Set-up; 1-9: WP1 Evidence synthesis; 2-15: WP2 Qualitative interviews; 7-15: WP3 Consensus; 14-22: WP4 DA development; 22-27: WP5 Field testing; 24-30: WP6 Economic model building; 9--30: Reporting and dissemination Findings will be published and shared widely. The DA will be ready for formal implementation and evaluation of impact (e.g. on knowledge, decisional regret, clinical outcomes, resource use). The implementation strategy will support the use of the DA in birth planning conversations in routine care, complementing emerging intrapartum decision support led by NHS England.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS;8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH