Abstract
BACKGROUND: The peanut ball has only been recently used as a support for women labouring with epidurals. The peanut ball is shaped like a peanut and fits snugly between the woman's legs so that both legs are maintained as opening the pelvic outlet to increase the progress of labour and facilitate descent of the fetal head. Using position changes during labour to enhance widening of the pelvic outlet can be beneficial but a woman who has an epidural is limited in the number of positions she can adopt. No randomised controlled trial has been implemented in Australia to establish the effectiveness of a peanut ball specifically for women using epidurals during labour, and this project addresses this gap. The main aim of this pilot study is to assess the feasibility and practicality of conducting and replicating this trial to a definitive randomised controlled trial (RCT). METHODS: A minimum number of 50 women (25 in each trial arm), who are using an epidural in labour at two hospitals in NSW over a 1-year period, will be recruited and randomly allocated into a group that uses the peanut ball or into a group that does not use the peanut ball. Primary study objectives include assessing the proportion of women willing to be randomised, retention/attrition rates, and with associated reasons. Data will be collected on key clinical outcomes (natural birth rate, length of stay) with means and variances estimated between trial arms. This will inform the appropriate powering of a future definitive RCT. Secondary study objectives will include investigating the completion and acceptability of health and satisfaction surveys and assess the feasibility of conducting an economic evaluation alongside a future trial. DISCUSSION: This is a two-armed randomised controlled pilot trial. Outcomes from this pilot will inform a larger trial at a tertiary hospital. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12618000662268.