Title: Physiological breech birth: a feasibility study for a pragmatic trial
Funder: Department of Health and Social Care

Abstract: Research question: Is it feasible to conduct a randomised controlled clinical trial, with economic and implementation evaluation, comparing physiological breech birth care (PBB) with standard NHS practice?Background: Some women feel pressured to accept an external cephalic version or caesarean section for breech pregnancies. Women have asked for 1) more research about non-surgical options; and 2) reliable, experienced support. Their wishes align with national policy objectives promoting maternal choice. The PBB care package includes specialist team leadership, evidence-based training and maternal choice of birthing position. PBB has never been compared to standard care in a trial.Methods: Mixed methods feasibility study, including: On-line Delphi survey (n=>28 stakeholders) to agree core and secondary outcomes. Survey of UK maternity units (n=151) to identify number willing and able to participate in a substantive trial. Small feasibility RCT (n=100). Participants randomised to either standard care (control) or PBB care (intervention). To identify 1) the percentage of women eligible, recruited and retained; 2) pooled outcome measures, including admissions to neonatal unit, vaginal birth rates, known caregiver in labour, satisfaction with care, demographics, health service use and quality of life outcomes, up to 2 years; and 3) methods of data collection, completeness and time required to collect. PBB implementation process evaluation involving staff surveys and experience tables (n=150), case note reviews (n=100), interviews with staff (obstetricians, midwives, anaesthetists, neonatologists and managers n=20), questionnaires (n=100) and interviews with women (n=20). To determine acceptability and fidelity of PBB implementation. Feasibility of long-term follow-up (n=20 women and their babies, followed up to 2 years), to determine indicative costs and benefits to the health service and society that could be used in a full trial. Economic decision-model of long-term cost-effectiveness and value of information. Settings: Four Trusts in South London.Timelines for delivery: Report dates - 9/2020: Delphi. 5/2021: Survey of maternity units. 3/2022: Feasibility for full trial. 6/2022: Implementation process evaluation. 12/2022: Economic evaluation recommendations.Anticipated impact and dissemination: The introduction of PBB into NHS settings is anticipated to improve women's access and outcomes of vaginal breech births. Five reports will be submitted to peer-reviewed journals, including PLOS One and The Lancet. Findings will be shared at the British Intrapartum Care Conference and used to guide a grant application for a full trial.The feasibility trial will: 1) enable precise predictions for a full RCT; and/or 2) identify adjustments that need be made to the intervention, implementation, randomisation or trial methods. The process evaluation will support faster and improved integration of PBB within NHS settings by refining the programme theory, providing a 'blueprint' for implementation. Refinement of data collection methods for resource, health service use and utilities will enable a full economic evaluation alongside a substantive trial. The economic model will provide an early estimate of likely long-term benefits and help indicate the value of future information from a trial. The survey of maternity units will inform sample calculations and modelling of costs required to support more widespread implementation of PBB, if found to be acceptable, effective and efficient.

Lay abstract: Most babies are born head-first (cephalic), but about 1 in 25 are in a bottom-down position (breech) after 36 weeks of pregnancy, and some are not detected until labour. These babies have some increased risk around the time of birth, so most are born by caesarean section. However this is also associated with some risks for the babies, for mothers and for future pregnancies. Mode of childbirth is a very personal decision. Women who have experienced breech pregnancies have asked for: more information about non-caesarean options; and reliable support from an experienced midwife or obstetrician if a vaginal birth is planned.These requests align with national policy to enable maternal choice. The Royal College of Obstetricians and Gynaecologists guideline indicates that with experienced attendants, a breech birth may be almost as safe as a cephalic birth. A package of care known as 'physiological breech birth' (PBB) may further reduce birth-related risks for the baby and increase the chance of a vaginal birth. PBB care includes: specialist team leadership, evidence-based training, and an active birth approach, including the mother's choice of birthing position.Previous research shows all three elements are necessary parts of the intervention. We do not know whether PBB is as safe and cost-effective as standard care for breech presentation at the end of pregnancy. One way to find out is by a clinical trial, to compare outcomes in women who have standard care with those who have physiological breech care. Some important questions must be answered first to design a successful large-scale trial. This is called a 'feasibility study.' The questions include: What outcomes are most important to women and professionals? An agreement on what should be measured will be developed using on-line surveys with women and experienced professionals. The main outcomes being considered are: admission to the neonatal unit, vaginal birth, known caregiver in labour, satisfaction with care, whether everyone has the same access (equity), health service use and quality of life outcomes, for 2 years after birth. How many women might wish to take part in a large trial? To predict this accurately, we will run a small version of the trial, aiming to recruit 100 women within four maternity units in South London. Can we collect all of the information we need, and how much time does it take? We will describe how much can be obtained from routinely collected data and how much needs to be asked of women and staff. How do women and staff feel about the interventions we are comparing? We will use surveys and interviews to collect views about the acceptability of PBB and standard care. How much does it cost to provide PBB care, compared to standard care? We will collect information about costs of providing care and how they are measured, so a large trial can determine if PBB represents good value for money. How many sites across the UK would be willing and able to participate in a full trial? We will survey all UK maternity units. Is a full trial likely to succeed? The information gathered in this feasibility study will help us to predict whether enough women might take part, and whether women and staff would find the PBB service acceptable if used more widely in the NHS following a trial.While developing this proposal, feedback was sought from South London Maternity Voices Partnerships, the Birth Trauma Association, and the Fast Track Review Service of the NIHR Research Design Service London. A group of women who have experienced a breech pregnancy in the UK will continue to be involved throughout the study and its dissemination.

Research activity codes: 6.7 PHYSICAL;7.1 INDIVIDUAL CARE NEEDS
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH