None listed
Conditions
Brief summary
This Feasibility RCT will randomise women to either use the Labour Support Chair or not during the active phase of their labour. We aim to discover if there are any differences in maternal or neonatal outcomes between the two groups and the acceptability of the use of the chair from women, and also midwives. This small trial will provide preliminary evidence in order to gain funds to undertake a statistically powered RCT in the future.
Interventions
The labouring women will be randomised to either use the Labour Support Chair, or not. The Labour Support Chair is a supportive device intended to be straddled by a woman in the first stage of labour to encourage fetal alignment with the maternal pelvis; it is not intended for use during childbirth. It is a backwards orientated chair, with a narrow waist and a supportive front panel extending to a headrest/arm platform top, designed to help facilitate optimal maternal spine/pelvic angle and posi
The labouring women will be randomised to either use the Labour Support Chair, or not. The Labour Support Chair is a supportive device intended to be straddled by a woman in the first stage of labour to encourage fetal alignment with the maternal pelvis; it is not intended for use during childbirth. It is a backwards orientated chair, with a narrow waist and a supportive front panel extending to a headrest/arm platform top, designed to help facilitate optimal maternal spine/pelvic angle and positioning before birth. Participants in the intervention arm will be asked to straddle the chair when in active labour - for a period of time that is comfortable for them. There is no limitation or length of time that we are asking them to sit on the chair for. Midwives will be trained to facilitate the use of the chair, record how long they straddle the chair for, and ensure adherence to the intervention by direct observation. For the focus groups, we will recruit 6-8 women who have used the chair to participate in a group 4-6 months after the birth. We hope to recruit a maximum of 8 women for three focus groups (8 in each group). Similarly we will recruit the same number of midwives who have facilitated the use of the chair to attend a focus group, and hope to have enough participants for three focus groups. The first 24 participants who agree to participate will be enrolled. The Focus groups will last around 45 minutes for each cohort. For women - we will discuss their experience of using the chair, whether it met their expectations and whether it was comfortable. We will ascertain their perceived benefits or difficulties using the chair and whether they think it affected their labour in any way. For midwives - we will ascertain their experience and Implementation of introducing the Labour Support Chair to women during labour, any challenges in incorporating the chair into routine care, and any perceived impact it may have had on the women they cared for. Also - whether there were any issues with the midwifery team regarding its use, whether they felt adequately trained to use the chair, and if they needed any more help/resources to facilitate its use.
Sponsors
Northern Sydney Local Health District
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Phase 1 (FRCT) - Inclusion criteria consist of pregnant women/people who: • Are 37 completed weeks gestation • Are equal to or over 18 years of age • Anticipate a vaginal birth • Are willing to use the Labour Support Chair during the active first stage of their labour if randomised to the intervention arm • Have signed the consent form Phase 2 (Qualitative)- Inclusion criteria includes: • Participants who have used the Labour Support Chair within the FRCT and; • Agree to be contacted for participation in an online Focus Group (by providing their contact details on the consent form) • Midwives who have facilitated use of the Labour Support Chair and; • Agree to participate in an online Focus Group.
Exclusion criteria
Phase 1 (FRCT) - Exclusion criteria consist of women/people who: • Are < 37 weeks gestation • Are planning an elective caesarean section • Do not have adequate English literacy • Have not signed the consent form Phase 2 (qualitative) – Exclusion criteria consist of: • Participants who do not agree to participate in an online Focus Group (who have not put their contact details on the consent form) • Participants and/or their babies who have had a serious adverse event/negative outcome during labour, birth or in the postnatal period* • Midwives who do not consent to participate in an online Focus Group • Midwives who have not facilitated use of the Labour Support Chair to participants
Outcome results
None listed