None listed
Conditions
Brief summary
The aims of this pilot study are three-fold: the practicality of conducting a formal trial and information needed including recruitment rates, to determine whether using a peanut ball for pregnant women who have an epidural during labour makes clinically significant different outcomes and inform whether to conduct a larger randomised controlled trial (RCT) to establish clinical and statistical significance. The assessment of endpoints is to determine if the peanut ball makes clinically significant different outcomes by comparing the intervention group that uses the peanut ball and the control group that does not use the peanut ball. Specifically it asks: Is there a difference between women using the peanut ball and those who do not in the rate of vaginal births? Is there a difference between women using the peanut ball and those who do not in the length of labour? Is there a difference in health service usage between arms, regarding staff time, medications, procedures and length of stay in hospital. Is there a difference in experience in labour, including health related quality of life? We hypothesise that placing the peanut ball between the labouring woman’s legs who has an epidural may facilitate the progress of labour (Tussey et al., 2015) and would be more likely to have a vaginal birth as opposed to a caesarean birth. We also hypothesise that women’s views about their own experience and health related quality of life will be more positive. Evidence of these outcomes will be evaluated more closely in the larger randomised control trial.
Interventions
Intervention group uses the peanut ball.
Control group does not use the peanut ball.
The group of women using the peanut ball will be provided an information and consent form about the background of the peanut ball. The midwives implementing the use of the peanut ball will be provided an education package about using the peanut ball covering storage, safety, maintenance and measurement on inflation of the peanut balls. Myself as the Chief Investigator of the project (midwife with 28 years’ exper
Intervention group uses the peanut ball. Control group does not use the peanut ball. The group of women using the peanut ball will be provided an information and consent form about the background of the peanut ball. The midwives implementing the use of the peanut ball will be provided an education package about using the peanut ball covering storage, safety, maintenance and measurement on inflation of the peanut balls. Myself as the Chief Investigator of the project (midwife with 28 years’ experience) have educated midwives and doctors about the use of the peanut ball (via face to face education sessions). The midwife will administer the peanut ball individually to each woman following effective pain relief from the epidural during labour. The peanut ball will be administered once only to each participant during labour. The woman will be required to change positions using the peanut ball every 30 minutes. The peanut ball will be used in the hospital birthing suites at two low risk maternity units. The intervention will be personalised by offering different positions to the woman using the peanut ball depending upon individual comfort. One of the positions facilitates pushing the baby in second stage of labour. The midwives have been educated about the positions that the woman can adapt whilst using the epidural. A component of this education package included documentation. If the woman has used the peanut ball during labour with an epidural, the midwife needs to document in the Powerchart – Citrix notes as progress notes. The documentation should include the wording: peanut ball. The midwife should also document in this section- the commencement time that the woman used the peanut ball post-epidural insertion. Ideally the woman should commence using the peanut ball following insertion of the epidural, when the epidural has taken effect, so that the woman is comfortable and pain-free. If the woman stops using the peanut ball for any reason prior to birthing, the time should also be documented, including the reason why she stopped using the peanut ball. Access to the progress notes will occur via the databases. There will be no direct observation of women during labour by research personnel as this is inappropriate.
Sponsors
Virginia Skinner
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
13 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
The sample will include women who are English and non-English speaking, at least 36 weeks gestation with a live fetus and present with a cephalic presentation. Pregnant primiparous and multiparous women.
Exclusion criteria
Women will be excluded if they develop moderate to severe pre-eclampsia, or experience severe essential hypertension and if they are being treated for insulin dependent diabetes (gestational or pre-pregnant). Women will also be excluded if the fetal heart rate trace is abnormal or suspicious or if they experience an intra-uterine death. Women having twin pregnancies will be excluded.
Outcome results
None listed