“…This study uses the same model (see Fig. 1 ) as the previously aforementioned three randomised control trials [ 13 – 15 ] in the USA, although Evans and Cremering (2016) only included women having their first babies and Roth et al (2016) only included women having an elective induction (not spontaneously labouring). Fig.…”
Section: Methodsmentioning
confidence: 99%
“…The survey will provide a snapshot about the woman’s experience and enquire about the benefits of using the peanut ball, subsequent use of the peanut ball, whether the woman would recommend using the peanut ball to other women and reasons why, discomfort, specific positions used with the peanut ball, experiencing feelings of empowerment and effect on length of labour and demographic details. The survey was developed in alignment with the results of the previous randomised controlled trials [ 13 – 15 ] and as this research only focuses on quantitative data, it was thought that it was beneficial to obtain some information from women about the comfort, perception and satisfaction about using the peanut ball as complementary evidence to the pilot randomised controlled trial. Face validity has been verified by this survey being reviewed and approved by an ethics committee of expert health research professionals in a local health district in NSW, and the survey will be further validated in this pilot study by comparing responses from both sites by using construct validity and establishing appropriate sample size.…”
Section: Methodsmentioning
confidence: 99%
“…Three randomised control trials have been implemented in the USA on the use of a peanut ball during labour [ 13 – 15 ]. Of the three randomised control trials in the USA, one of the randomised control trials included women who were scheduled for elective induction of labour and also who used an epidural for labour pain.…”
Section: Introductionmentioning
confidence: 99%
“…Even though the findings were clinically significant, they were not statistically significant. There was no difference in the length of stages of labour [ 15 ]. One of the randomised control trials showed that using the peanut ball was associated with a significantly lower incidence of caesarean surgery (OR = 0.41, p = .04) and is potentially a successful intervention to help progress labour and support vaginal birth for women labouring with an epidural anaesthesia.…”
BackgroundThe 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).MethodsA 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.DiscussionThis is a two-armed randomised controlled pilot trial. Outcomes from this pilot will inform a larger trial at a tertiary hospital.Trial registrationAustralian New Zealand Clinical Trials Registry, ACTRN12618000662268Electronic supplementary materialThe online version of this article (10.1186/s40814-018-0346-9) contains supplementary material, which is available to authorized users.
“…This study uses the same model (see Fig. 1 ) as the previously aforementioned three randomised control trials [ 13 – 15 ] in the USA, although Evans and Cremering (2016) only included women having their first babies and Roth et al (2016) only included women having an elective induction (not spontaneously labouring). Fig.…”
Section: Methodsmentioning
confidence: 99%
“…The survey will provide a snapshot about the woman’s experience and enquire about the benefits of using the peanut ball, subsequent use of the peanut ball, whether the woman would recommend using the peanut ball to other women and reasons why, discomfort, specific positions used with the peanut ball, experiencing feelings of empowerment and effect on length of labour and demographic details. The survey was developed in alignment with the results of the previous randomised controlled trials [ 13 – 15 ] and as this research only focuses on quantitative data, it was thought that it was beneficial to obtain some information from women about the comfort, perception and satisfaction about using the peanut ball as complementary evidence to the pilot randomised controlled trial. Face validity has been verified by this survey being reviewed and approved by an ethics committee of expert health research professionals in a local health district in NSW, and the survey will be further validated in this pilot study by comparing responses from both sites by using construct validity and establishing appropriate sample size.…”
Section: Methodsmentioning
confidence: 99%
“…Three randomised control trials have been implemented in the USA on the use of a peanut ball during labour [ 13 – 15 ]. Of the three randomised control trials in the USA, one of the randomised control trials included women who were scheduled for elective induction of labour and also who used an epidural for labour pain.…”
Section: Introductionmentioning
confidence: 99%
“…Even though the findings were clinically significant, they were not statistically significant. There was no difference in the length of stages of labour [ 15 ]. One of the randomised control trials showed that using the peanut ball was associated with a significantly lower incidence of caesarean surgery (OR = 0.41, p = .04) and is potentially a successful intervention to help progress labour and support vaginal birth for women labouring with an epidural anaesthesia.…”
BackgroundThe 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).MethodsA 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.DiscussionThis is a two-armed randomised controlled pilot trial. Outcomes from this pilot will inform a larger trial at a tertiary hospital.Trial registrationAustralian New Zealand Clinical Trials Registry, ACTRN12618000662268Electronic supplementary materialThe online version of this article (10.1186/s40814-018-0346-9) contains supplementary material, which is available to authorized users.
“…The bias about different areas was found as follows: random sequence generation was low risk in five studies (D'Angelo, 2015;Evans, 2014;Roth et al, 2016;Tussey et al, 2015;Mercier, & Kwan, 2018), and high risk in one study (Payton, 2015);…”
Section: Risk Of Bias Of Included Studiesmentioning
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