We are in the process of developing the protocol and study materials for Stage 2 of the OptiBreech study which will be a multi-centre prospective observational cohort study designed to support multiple trials of care for women with a breech pregnancy at term.
In the next phase of our study, we will begin to record outcomes for breech pregnancies and births from several more hospitals across England, Wales and Scotland, on a large database. Personal information, such as names and NHS numbers, will be kept separately from information on the outcomes of pregnancies, so that those who participate are not identified by anyone looking at the data. We will need to collect a lot of data and store it for a long time, so it’s important we get this right. We want to ensure we are providing information about the study in a way that is clear and ethical.
OptiBreech 2 will involve randomly allocating women to different care pathways, and creating a large scale database of term breech pregnancies for the purposes of 1) establishing safety outcomes in real-world settings and 2) conducting multiple nested trials to establish effectiveness of interventions in the breech care pathway.
Also, we will be asking some women to allow us to assign them by chance to one treatment or another; this is called ‘randomisation.’ Assigning people by chance enables us to be sure that any differences we see in outcomes are due to the treatment and not something else. For this reason, evidence obtained following random assignment is considered the highest quality evidence. We would like to know how you feel about this and how we are proposing to do it.
We would like to hear your views on the acceptability of randomisation as well as on the Participant information sheet and Consent forms (linked below).
We’ve created a Participant Information Sheet, with information about the study, and a Consent form, which we would need each participant to sign. We would like to ensure these are clear. And we invite you to tell us if you think we should be doing something differently.
The meeting will be held on Wednesday 16th June, 11:00–12:00 via Microsoft Teams.
The link to join: https://teams.microsoft.com/l/meetup-join/19%3ameeting_NjY2YWU3ZGUtYjUwMi00NmQxLWE0ZjMtZGUwMjFlNzRlNmIw%40thread.v2/0?context=%7b%22Tid%22%3a%228370cf14-16f3-4c16-b83c-724071654356%22%2c%22Oid%22%3a%220b7b88cc-f549-43c3-a733-ff811056d022%22%7d
We hope to see you there!
This research is funded by an NIHR Advanced Fellowship. The entire process took about 2 years, from the early stages of writing (2018) to the time the fellowship began (2020). The final design of the research was influenced by further PPI work with service users and professionals in participating sites.
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. 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.