IntroductionObstetric anal sphincter injury (OASIS) occurs in 5%–7% of normal deliveries and increases with vacuum extraction (VE) to 12%–14% in nulliparous women in Sweden. Lateral/mediolateral episiotomy may reduce the prevalence of OASIS at VE in nulliparous women. The current use of episiotomy is restrictive. The protective effect and consequences are uncertain. This trial will investigate if lateral episiotomy can reduce the prevalence of OASIS and assess short-term and long-term effects.Methods and analysisThis is a multicentre randomised controlled trial of lateral episiotomy versus no episiotomy in nulliparous women with a singleton, live fetus, after gestational week 34+0 with indication for VE. A lateral episiotomy of 4 cm is cut at crowning, 1–3 cm from the midline, at a 60° angle. The primary outcome is OASIS by clinical diagnosis analysed according to intention to treat. To demonstrate a 50% reduction in OASIS prevalence (from 12.4% to 6.2%), 710 women will be randomised at a 1:1 ratio. Secondary outcomes are pain, blood loss, other perineal injuries, perineal complications, Apgar score, cord pH and neonatal complications. Web-based questionnaires at baseline, 2 months, 1 and 5 years will be used to assess pain, incontinence, prolapse, sexual function, quality of life and childbirth experience. A subset of women will receive follow-up by pelvic floor sonography and pelvic examination. Mode of delivery and recurrence of OASIS/episiotomy in subsequent pregnancies will be assessed at 5 and 10 years using register data.Ethics and disseminationThe trial is open for enrolment. The trial has received ethical approval from the Regional Ethical Review Board of Stockholm and full funding from the Swedish Research Council. Women are interested in participation. The predominant restrictive view on episiotomy may limit recruitment. Results are of global interest and will be disseminated in peer-reviewed journals and at international congresses.Trial registration numberNCT02643108; Pre-results.

Background Perineal tears are common after vaginal birth and may result in pelvic floor symptoms. However, there is no validated questionnaire that addresses long-term symptoms in women with a deficient perineum after vaginal birth. Thus, the objective of this study was to develop and psychometrically evaluate a clinical screening inventory that estimates subjective symptoms in women with a deficient perineum more than one year after vaginal delivery. Material and methods The development and psychometric evaluation employed both qualitative and quantitative methods. Qualitative strategies involved content validity and Think Aloud protocol for generation of items. The psychometric evaluation employed principal component analysis to reduce the number of items. The inventory was completed by women with persistent symptoms after perineal tears (N = 170). Results were compared to those of primiparous women giving birth by caesarean section (N = 54) and nulliparous women (N = 338). Results A preliminary 41-item inventory was developed, and the psychometric evaluation resulted in a final 11-item inventory. Women with confirmed deficient perineum after perineal trauma scored significantly higher on the symptoms inventory than women in control groups. A cut-off value of ≥ 8 could distinguish patients from controls with high sensitivity (100%) and specificity (87–91%). Conclusions The Karolinska Symptoms After Perineal Tear Inventory, is a psychometrically valid 11-item patient-reported outcome measure for symptoms of deficient perineum more than one year after vaginal birth. More research is needed to validate the inventory in various patient populations as well as its use in pelvic floor interventions. The inventory has the potential to improve patient counseling and care in the future.

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