None listed
Conditions
Brief summary
The primary aim of this project is to test the feasibility of recruitment, retention, data collection and analysis for a fully-powered randomised controlled trial (RCT). This is to evaluate the effectiveness of the rebozo technique in improving birth experiences and outcomes in first time mothers utilising epidural analgesia. As the rebozo technique is an under-researched method to optimise fetal position for labour and birth, a pilot RCT is needed to determine feasibility to a fully-powered RCT. The study participants will be low risk first time mothers using an epidural. The intervention will be the rebozo technique, and the comparison group will be standard care provided by midwives. Primary outcomes are proportion of women who meet inclusion criteria give consent to participate; proportion of women who give consent are randomised; proportion of women who receive allocated intervention; proportion of participants who withdraw from the study; proposition of participant data collection sheets completed; and number and nature of adverse events.
Interventions
This pilot trial will utilise the rebozo technique, which is used by some midwives to correct fetal malposition that contributes to rates of assisted vaginal birth (AVB). It will be used once, over a period of approximately 5 minutes. This technique will be used once second stage labour has been established, but before pushing begins. Midwives will be trained in the appropriate application of this intervention, and the lead researcher will be on site during business hours to assist and monitor.
This pilot trial will utilise the rebozo technique, which is used by some midwives to correct fetal malposition that contributes to rates of assisted vaginal birth (AVB). It will be used once, over a period of approximately 5 minutes. This technique will be used once second stage labour has been established, but before pushing begins. Midwives will be trained in the appropriate application of this intervention, and the lead researcher will be on site during business hours to assist and monitor. The rebozo is a standard sheet, placed underneath the woman’s back and hips. Once second stage is confirmed with full dilation, but before pushing commences, with two midwives on either side, the woman is to be rocked side to side using a standard sheet, placed underneath the woman' back and hips. The intervention is applied 4 times, then allow her to rest on her left side for 2 minutes, then immediately repeat.
Sponsors
The University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Term. • Cephalic. • Singleton. • Epidural/combined spinal epidural. • Nulliparous. • >18 years. • Spontaneous or induced labour. • Requesting epidural analgesia in first stage labour.
Exclusion criteria
Exclusion criteria for consent: • Unable to provide informed consent. • Serious medical complication(s) of pregnancy and/or chronic medical condition(s) eg. pre-eclampsia, insulin controlled gestational diabetes, heart disease. • Induction for pelvic instability/pubic symphysis separation. • Small for gestational age, Intrauterine growth restriction. • Maternal or fetal contraindications to vaginal birth. • BMI >35. • Culturally and linguistically diverse women without access to an interpreter. Additional exclusion criteria at randomisation: • Station equal to or higher than -3 at full dilation • equal to or lower than +2 at full dilation • Continued and prolonged patterns of variables/complicated variables/late decelerations at full dilation
Outcome results
None listed