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 Oneand 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.