Plain English Summary
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. In this study, we are exploring whether it would be feasible to evaluate a new care pathway for women with a breech pregnancy. The OptiBreech care pathway includes:
• specialist leadership,
• evidence-based training, and
• an active birth approach.
We do not know whether OptiBreech care is as safe and cost-effective as standard care. One way to find out is by a clinical trial, to compare outcomes in women who have received care through an OptiBreech care pathway with those who have received standard NHS care.
Some important questions must be answered first to design a successful large-scale trial. This is called a ‘feasibility study.’ We will use routine data, interviews and surveys to determine:
- 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 104 women across 5 of the participating sites.
- 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 OptiBreech care and standard care.
- How much does it cost to provide OptiBreech 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 OptiBreech care 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 OptiBreech service acceptable if used more widely in the NHS following a trial.
Twelve sites from across England, Wales and Scotland will participate. An independent Trial Steering Committee will consider outcomes from this initial study and advise on whether a large trial is feasible.
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.