Feasibility of Postpartum Community Research: Results of a Systematic Review and A Pilot Randomized Controlled Trial to Optimize Postpartum Health Through Self-Scar Massage
Date
2024-05-29
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Abstract
Background The postpartum population is under-represented and under-funded in research. Postpartum pelvic health dysfunction is common, yet few evidence-informed pelvic health treatment options exist. Objectives 1. Assess feasibility of a randomized controlled trial (RCT) investigating self-massage of postpartum pelvic floor scar tissue on pelvic health outcomes. 2. Perform a systematic review to determine recruitment rate and retention in RCTs studying the postpartum population and recruitment strategies used in successful trials. Methods A pilot RCT was conducted to examine feasibility for a larger trial. Eligible and consenting primiparous postpartum adults with healed perineal tear(s) and/or episiotomy in Calgary, Alberta, were recruited for participation between 42 and 365 days postpartum. Participants were randomized into two groups with a 1:1 allocation. The intervention group performed self-scar massage of their pelvic floor scar tissue and the control group received routine postnatal care. Patient medical records were used to collect demographic and obstetrical data. All participants were asked to complete two reliable and validated pelvic health questionnaires upon enrollment in the study and then again 6 weeks later. The primary analysis determined the monthly recruitment rate, acceptability of intervention and questionnaires, and participant adherence to the intervention protocol. For the systematic review, eligible studies were selected through an electronic literature search. Databases were searched for original RCTs investigating interventions between 42 and 365 days postpartum that recruited participants postpartum. Results For the pilot RCT, the recruitment rate was one participant/month (n=6), and participant retention was 100%. Participants deemed the intervention and outcome measures acceptable, but reported challenges adhering to the intervention protocol, at times, due to competing demands of newborn care. For the systematic review, 39 studies were included from 18,580 records initially identified. The median recruitment rate was 6.58 participants/recruitment site/month (Interquartile Range (IQR):2.92-9.21) and the median percentage of retained participants was 90% (IQR:80-96). Conclusions Due to low recruitment rates for the pilot RCT, a future trial was deemed infeasible if the existing indirect recruitment strategy was used. Findings from the systematic review suggest that a future targeted recruitment approach may be preferred based on strategies used in postpartum RCTs with successful recruitment.
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Keywords
scar tissue massage, pelvic health, pelvic floor, episiotomy, perineal tear, postpartum, recruitment
Citation
Cerantola, G. (2024). Feasibility of postpartum community research: results of a systematic review and a pilot randomized controlled trial to optimize postpartum health through self-scar massage (Master's thesis, University of Calgary, Calgary, Canada). Retrieved from https://prism.ucalgary.ca.