BUMPES

BUMPES Trial

(Birth in Upright Maternal Position with Epidural in Second Stage) 

Mary Nolan, NCT Antenatal tutor and NCT representative on the BUMPES project 

The BUMPES Trial is investigating whether assisted delivery is related to the position which a woman adopts in second stage labour, if she has a mobile epidural in situ. The study is being organized by the National Perinatal Epidemiology Unit in Oxford, under the chairmanship of Professor Peter Brocklehurst. The research team consists of anaesthetists, obstetricians, midwives, health economists and statisticians from England and Wales, and myself as the lay representative.

Meetings of the team commenced in 2008 and the following 12 months were spent in putting together the research proposal, submitting it to the funding body (National Coordinating Centre for Health Technology Assessment), responding to lengthy and complex feedback from the HTA, and finally gaining ethics approval.

The pilot phase of the study is due to commence in 2010 at Birmingham Women’s Hospital. Women expecting their first baby, who agree to take part in the trial and who are labouring with an epidural will be randomly allocated to use either upright or lying down positions in second stage labour. How exactly ‘upright’ and ‘lying down’ should be defined required many many hours of discussion at meetings taking place over several months (and the issue of whether ‘all fours’ should be considered upright is still causing some difficulties!) The Patient Information Leaflet includes pictures to explain to women and to assist midwives in understanding what counts as an upright position and what as a lying down position in the trial’s terms. It is important to stress that the trial defines lying down as semi-recumbent and not as supine.

At the end of the nine months pilot study, the trial will be rolled out to four other hospitals in England and Wales and will aim to recruit 3000 women over 24 months. Midwives involved in the trial will be offered training and support.

The primary outcome measure is the rate of spontaneous vaginal birth among women participating in the trial. Various other outcomes are also being investigated, including episiotomy rate, perineal trauma, primary post-partum haemorrhage, method of pushing (active or passive), baby’s APGAR scores and duration of mother’s and baby’s postnatal stay. A year after giving birth, women will receive a questionnaire asking them about their postnatal health.  

Key issues for NCT

My involvement as a lay member of the team was warmly welcomed by Peter Brocklehurst and respected by all team members. I found myself most interested and involved in the debate around how to define upright and lying down positions, and in discussing what measures of wellbeing might be important to women when following them up a year after their initial participation in the study.

Reviewing the patient information leaflets (PILs) was also a major interest for me, ensuring that the language used was as accessible as possible to the very wide range of women who would be approached to take part in the trial.

I felt that the woman’s perspective was always taken into account by the trial team, and I certainly didn’t have to ‘fight’ to ensure that women’s comfort, choices and dignity were to the forefront of the team’s deliberations.

Clearly, when considering issues around releasing staff for training in implementing the trial protocol, and around the burden the trial would place on participating centres, I had less to offer as these are service issues of which I have no first-hand knowledge. Nor was I of any use whatsoever when considering appropriate statistical analysis of the data that would be obtained from the trial!

Being a part of the BUMPES team has undoubtedly taught me a very great deal about the complexity of multicentre trials recruiting thousands of women, and also about the benefits of bringing together people from different disciplines (midwifery, obstetrics, anaesthetics, health economics, statistics) to contribute their expertise to a particular research question. Reading the considerable amount of paperwork associated with each meeting and seeking to understand it, and actually attending meetings is time-consuming. Sometimes one feels a very small person at a table with very big people, but the experience is invaluable in developing understanding of the research process and respect for the commitment and expertise of those who undertake trials to which huge sums of money have been allocated.

January 2010