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Alleviating perineal trauma - the APT studyThe objectives of this study were to evaluate the effectiveness of a new cooling device (gel pad) and compare it with a standard regimen (ice pack) and a no localised treatment regimen (control). The study was a randomised controlled trial, initially based in a hospital midwifery unit in the North of England and then continued in the community. Participants were 450 women who had undergone either a normal or an instrumental delivery that required suturing of an episiotomy or second degree tear. The measurements and findings were as follows: 316 (71%) of completed questionnaires were returned. A significant reduction in the levels of oedema was observed in favour of using cooling treatments at day two and day five, p=0.016. p=0.018, and there was a significant reduction in bruising at day ten, p=0.01 (using the Kruskal-Wallis test). Self-reported pain was less in the cooling gel pad group. A significant reduction in pain was demonstrated at day five, day ten and day 14, p=0.023, p=0.007, p=0.058, (Kruskal-Wallis test). A reduction in pain was reported earlier on day two, day three and day five when making a binary comparison of moderate or severe pain, with none or mild, p=0.0038, p=0.037, p=0.017 (chi-squared test). Maternal satisfaction With the cooling gel pad was high and differed statistically significantly compared to the other regimens, p=0.0005, (Kruskal-Wallis test). There were no clinical significant differences monitored between groups when assessing healing. The key conclusions were that this clinical trial confirms earlier findings in a previous study and provides evidence that the use of a specifically designed cooling gel pad is a safe and effective localised method to alleviate perineal trauma, without any adverse effects on healing.