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Use of the Rebozo in second stage labour to reduce the incidence of assisted vaginal births for nulliparous women: A pilot randomised controlled trial

Year: 2025
Type: article
Study design: Clinical Trial
Abstract: BACKGROUND: Nulliparous women utilising epidural analgesia are more likely to experience fetal malposition, leading to assisted vaginal births. Current methods reducing this risk appear largely ineffective. Anecdotal reports suggest some midwives using Rebozo, a gentle rocking movement, helps prevent and correct fetal malposition, however evidence from randomised trials is lacking. Complex clinical trials require pilot testing of design feasibility to be successful. AIM: To test feasibility of recruitment, retention, data collection and analysis for a fully powered randomised controlled trial of Rebozo. METHODS: Unblinded parallel 1:1 pilot randomised controlled trial was undertaken at two sites in Southeast Queensland. Nulliparous women with a term, singleton cephalic pregnancy using epidural analgesia were randomised to Rebozo or standard care. Primary feasibility outcomes were assessed against progression criteria. RESULTS: Three of five feasibility criteria were not met. Of 73 women eligible for participation, 65.8 % (n = 48) (>80.0 % target) provided consent. Of these, 43.8 % (n = 21) became ineligible prior to randomisation at second stage labour. Completed data forms (44.0 % with target of >80.0 %) and withdrawals (7.4 % with target of <5 %) also failed feasibility criteria. Protocol compliance and absence of adverse events met targets. DISCUSSION/CONCLUSION: Effective strategies to improve recruitment, attrition and study fidelity would be required for a successful trial examining the efficacy of Rebozo in reducing assisted vaginal births for nulliparous women utilising epidural analgesia. Funding for dedicated research midwives may assist in addressing most feasibility issues.
Language: English
Field: Medicine
Open Access status: hybrid
Estimated APC paid: $3,613
OpenAlex ID: W4416256945
FWCI:
Cites: 35
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