Episiotomy in vacuum extraction, do we cut the levator ani muscle? A prospective cohort study.

INTRODUCTION AND HYPOTHESIS: Vaginal delivery may lead to levator ani muscle (LAM) injury or avulsion. Episiotomy may reduce obstetric anal sphincter injury in operative vaginal delivery, but may increase the risk of LAM injury. Our aim was to assess whether lateral episiotomy in vacuum extraction (VE) in primiparous women causes LAM injury. METHODS: A prospective cohort study of 58 primiparous women with episiotomy nested within an ongoing multicenter randomized controlled trial of lateral episiotomy versus no episiotomy in VE (EVA trial) was carried out in Sweden. LAM injury was evaluated using 3D endovaginal ultrasound 6-12 months after delivery and Levator Ani Deficiency (LAD) score. Episiotomy scar properties were measured. Characteristics were described and compared using Chi-squared tests. We stipulated that if a lateral episiotomy cuts the LAM, ≥50% would have a LAM injury. Among those, ≥50% would be side specific. We compared the observed prevalence with a test of one proportion. RESULTS: Twelve (20.7%, 95% CI 10.9-32.9) of 58 women had a LAD (p < 0.001, compared with the stipulated 50%). Six (50.0%, 95% CI 21.1% to 78.9%) of 12 women had a LAD on the episiotomy side, including those with bilateral LAD (p = 1.00). Two (16.7%, 95% CI 2.1% to 48.4%) of 12 women had a LAD exclusively on the episiotomy side (p = 0.02). CONCLUSIONS: There was no excessive risk of cutting the LAM while performing a lateral episiotomy. LAD was not seen in women with episiotomies shorter than 18 mm.

Development and initial validation of a Swedish inventory to screen for symptoms of deficient perineum in women after vaginal childbirth: 'Karolinska Symptoms After Perineal Tear Inventory'.

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.

Lateral episiotomy versus no episiotomy to reduce obstetric anal sphincter injury in vacuum-assisted delivery in nulliparous women: study protocol on a randomised controlled trial.

INTRODUCTION: Obstetric 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 ANALYSIS: This 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 DISSEMINATION: The 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 NUMBER: NCT02643108; Pre-results.