One Plus One Equals Two—will that do? A trial protocol for a Swedish multicentre randomised controlled trial to evaluate a clinical practice to reduce severe perineal trauma {1}

BACKGROUND: Severe perineal trauma sustained during childbirth is a serious complication since it can lead to both short- and long-term consequences for women. Some of the methods used to prevent perineal injuries have been evaluated in clinical trials, but there are still gaps in the evidence. A new clinical practice has been introduced, adopted by more than half of the maternity wards in Sweden with the aim of reducing severe perineal trauma. This procedure involves two midwives assisting the woman during the second stage of labour. METHODS/DESIGN: In this multicentre randomised controlled trial, 2946 women will be randomised to be assisted by one or two midwives during the second stage of labour. Women age 18–47, who plan for their first vaginal birth, with a singleton pregnancy in cephalic presentation, will be asked to participate when admitted to the maternity ward. Five maternity wards comprising 19,500 births/year in different parts of Sweden will participate in this study. The sample size is powered to demonstrate a 50% reduction (from 4.1–2.0%) in primary outcome, which is the prevalence of severe perineal trauma (3rd and 4th degree). Secondary outcomes will include maternal and neonatal outcomes, women’s experiences, midwives’ experiences of the intervention, incontinence, and pelvic floor symptoms. The primary analysis is intention to treat. Questionnaires will be sent to the women at 1 month and 1 year after the birth to assess women’s experiences, pain, incontinence, pelvic floor symptoms, sexual function, and mental health. DISCUSSION: It is important for care during labour and birth to be evidence based. There is a strong desire among midwives to reduce the risk of severe perineal trauma. This may lead to new strategies and practices being implemented into practice without scientific evidence. The intervention might have negative side effects or unintended consequences. On the other hand, there is a possibility of the intervention improving care for women. TRIAL REGISTRATION {2A}: ClinicalTrials.gov NCT03770962. Registered on 10 December 2018