Childbirth Acquired Perineal Trauma study (CHAPTER): a UK prospective cohort study protocol.

ABSTRACT

INTRODUCTION: Childbirth-related perineal trauma (CRPT) is the most common complication of childbirth affecting 80% of women overall after vaginal birth. There remains a lack of comprehensive evidence relating to the prevalence of subsequent health problems. Current evidence is related to short-term outcomes, for example, pain, but there is less known about longer-term outcomes such as infection, wound dehiscence, pelvic floor function and psychological outcomes. This is a protocol for a cohort study assessing outcomes of women after CRPT. METHODS AND ANALYSIS: A multicentre, prospective UK cohort study aiming to include 1000 women. All women who have sustained CRPT will be eligible for inclusion and will be followed-up for 12 months after childbirth. The primary outcome will be perineal infection at 6 weeks post-birth. Secondary outcomes will include antibiotic use for perineal infection, wound breakdown, use of analgesia, the requirement for admission or surgical intervention, urinary and faecal incontinence, anxiety and depressive symptoms, sexual function and impact on daily activities. Outcomes will be measured at 6 weeks, 6 months and 12 months post partum, with some outcomes being measured at all time points and others at selected most appropriate time points only. Outcome data will be obtained from a review of clinical notes and from patient questionnaires. Simple descriptive statistics will be used to summarise characteristics and outcomes, with categorical variables expressed as percentages and continuous variables as mean averages, alongside the corresponding standard deviatons. ETHICS AND DISSEMINATION Ethical approval has been granted by the Research Ethics Council with reference 23/WA/0169. Data collected from the Childbirth Acquired Perineal Trauma (CHAPTER) cohort study will highlight the prevalence and type of complications after CRPT and which women are more at risk. After the conclusion of this study, findings will be used to work with governmental organisations and Royal Colleges to target resources and ultimately improve care.