Format

Send to

Choose Destination
Pilot Feasibility Stud. 2018 Oct 4;4:156. doi: 10.1186/s40814-018-0346-9. eCollection 2018.

Using a peanut ball during labour versus not using a peanut ball during labour for women using an epidural: study protocol for a randomised controlled pilot study.

Author information

1
School of Nursing and Midwifery Centre for Nursing and Midwifery Research, Nepean Hospital, 1st level Court Building, Derby St, Kingswood, NSW 2340 Australia.
2
2Nepean Hospital, Derby St, Kingswood, NSW 2340 Australia.
3
Lithgow Hospital, Corner Col Drewe Drive and Great Western Highway, Lithgow, NSW 2790 Australia.
4
Centre for Nursing and Midwifery Research, Nepean Hospital, 1st level Court Building, Derby St, Kingswood, NSW 2340 Australia.
5
Translational Health Research Institute, Building 3, David Pilgrim Avenue, Campbelltown, NSW 2560 Australia.

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.

KEYWORDS:

Epidural; Labour; Peanut ball

Conflict of interest statement

Ethics approval for this study was granted in April 2018 by the Nepean Blue Mountains Local Health District HREC/18/Nepean/30 and the Western Sydney University Human Research Ethics Committee Reciprocal Approval REDI Reference: RH12693. Written consent for participation will be obtained prior to randomisation.Not applicable.The authors declare that they have no competing interests.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Supplemental Content

Full text links

Icon for BioMed Central Icon for PubMed Central
Loading ...
Support Center