Lateral episiotomy or no episiotomy in vacuum assisted delivery in nulliparous women (EVA): multicentre, open label, randomised controlled trial.

OBJECTIVE: To assess the effect of lateral episiotomy, compared with no episiotomy, on obstetric anal sphincter injury in nulliparous women requiring vacuum extraction. DESIGN: A multicentre, open label, randomised controlled trial. SETTING: Eight hospitals in Sweden, 2017-23. PARTICIPANTS: 717 nulliparous women with a single live fetus of 34 gestational weeks or more, requiring vacuum extraction were randomly assigned (1:1) to lateral episiotomy or no episiotomy using sealed opaque envelopes. Randomisation was stratified by study site. INTERVENTION: A standardised lateral episiotomy was performed during the vacuum extraction, at crowning of the fetal head, starting 1-3 cm from the posterior fourchette, at a 60° (45-80°) angle from the midline, and 4 cm (3-5 cm) long. The comparison was no episiotomy unless considered indispensable. MAIN OUTCOME MEASURES: The primary outcome of the episiotomy in vacuum assisted delivery (EVA) trial was obstetric anal sphincter injury, clinically diagnosed by combined visual inspection and digital rectal and vaginal examination. The primary analysis used a modified intention-to-treat population that included all consenting women with attempted or successful vacuum extraction. As a result of an interim analysis at significance level P<0.01, the primary endpoint was tested at 4% significance level with accompanying 96% confidence interval (CI). RESULTS: From 1 July 2017 to 15 February 2023, 717 women were randomly assigned: 354 (49%) to lateral episiotomy and 363 (51%) to no episiotomy. Before vacuum extraction attempt, one woman withdrew consent and 14 had a spontaneous birth, leaving 702 for the primary analysis. In the intervention group, 21 (6%) of 344 women sustained obstetric anal sphincter injury, compared with 47 (13%) of 358 women in the comparison group (P=0.002). The risk difference was -7.0% (96% CI -11.7% to -2.5%). The risk ratio adjusted for site was 0.47 (96% CI 0.23 to 0.97) and unadjusted risk ratio was 0.46 (0.28 to 0.78). No significant differences were noted between groups in postpartum pain, blood loss, neonatal outcomes, or total adverse events, but the intervention group had more wound infections and dehiscence. CONCLUSIONS: Lateral episiotomy can be recommended for nulliparous women requiring vacuum extraction to significantly reduce the risk of obstetric anal sphincter injury. TRIAL REGISTRATION: ClinicalTrials.gov NCT02643108.

MINIMIZING TEARING DURING VAGINAL DELIVERY WITH A PERINEAL PROTECTION DEVICE - A RANDOMIZED CONTROLLED TRIAL.

BACKGROUND: There is a growing body of evidence indicating that second degree tears cause both short-, and long-term consequences. Very few preventative measures have been found to reduce the incidence of these tears. OBJECTIVE: To investigate if the use of a perineal protection device during vaginal birth reduces severe perineal tearing (≥grade 2 tear) in primiparous women compared to routine manual perineal support. STUDY DESIGN: A single center randomized controlled trial was performed in Sweden 2019-2021. Primiparous women at term were randomly allocated to the intervention group (n=43) where a perineal protection device was used, or to receive routine care (n=49). Main outcome measurement was grade of perineal tear. Secondary outcomes were vaginal and labial tearing. Continuous data was analyzed with Student's T-test or Mann-Whitney U-test. Dichotomous data were analyzed with Pearson X2 test, Fisher's Exact test, and ordinal logistic regression. RESULTS: Women in the intervention group had a significantly lower risk of sustaining more extensive perineal tearing as compared to the control group. Use of the perineal protection device decreased risk of ≥grade 2 tears, in relation to grade 0-1 tears (OR 0.40 [95% CI 0.17-0.94]). Ordinal logistic regression analyses revealed an OR of 0.36 (0.16-0.81) for one-grade-injury increment, using the perineal protection device vs control group (p=0.013). Number needed to treat using the perineal protection device was 4.3 to avoid one ≥grade 2 tear. Women in the treatment group had less labial tearing (p=0.016). No adverse effects were detected. CONCLUSIONS: Use of the perineal protection device reduced the risk of perineal tearing ≥grade 2 tear by 60% as well as labial tearing.

[Preterm delivery: an overview on prediction, prevention and treatment]. / Prediktion, prevention och behandlingsmetoder.

Due to a low level of understanding of mechanisms involved in spontaneous preterm delivery there is a lack of reliable biomarkers. Existing biomarkers have a low positive predictive value but a high negative predictive value. Use of tests with high negative predictive value will reduce unnecessary interventions and hospitalization of women with threatening preterm delivery. When given to the right pregnant women, antenatal corticosteroid treatment are still the most important obstetrical intervention and reduces both neonatal mortality and short- and long-term morbidity.Several ongoing national Swedish multicenter studies may increase the understanding of the roles of cervical length, preeclampsia screening and magnesium sulfate dosage in the context of preterm delivery in a Nordic setting. Major development has been achieved in prediction and prevention of preterm preeclampsia at the cost of a 10% screen positive rate.

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.

Risk of surgically managed pelvic floor dysfunction in relation to age at first delivery.

OBJECTIVE: The purpose of this study was to compare the risk of surgically treated stress urinary incontinence (SUI) and pelvic organ prolapse (POP) in relation to mode of delivery and age at first childbirth. STUDY DESIGN: This was a cohort study. Data from the Swedish Medical Birth Register on women with only cesarean delivery (n = 30,880 women) or only vaginal delivery (n = 59,585 women) were compared with the Swedish Patient Register to calculate incidence rates and hazard ratios (95% confidence interval [CI]) for SUI and POP surgery. RESULTS: In analyses that were stratified by age, vaginal delivery consistently increased the risks of SUI and POP surgery. Among vaginally delivered women who were ≥ 30 years old, incidence rates of POP surgery were 13.8 (95% CI, 12.7-15.1), and for younger women were 6.4 (95% CI, 6.0-6.8) per 10,000 person-years. Exclusion of instrumental vaginal delivery did not alter the conclusions. CONCLUSION: Increasing age at first delivery increased the risk of subsequent SUI and POP surgery after both vaginal and cesarean delivery.

Risks of stress urinary incontinence and pelvic organ prolapse surgery in relation to mode of childbirth.

OBJECTIVE: To estimate the risk for stress urinary incontinence and pelvic organ prolapse surgery related to vaginal birth or cesarean delivery. STUDY DESIGN: A cohort study of all women having their first and all subsequent deliveries by cesarean (n = 33,167), and an age-matched sample of women only having vaginal deliveries (n = 63,229) between 1973 and 1983. Hazard ratios were calculated using Cox regression models with 95% confidence intervals. RESULTS: Women only having vaginal deliveries had increased overall risks of incontinence (hazard ratio, 2.9; 95% confidence interval, 2.4-3.6) and prolapse surgery (hazard ratio, 9.2; 95% confidence interval, 7.0-12.1) compared with women only having cesarean deliveries. CONCLUSION: Having only vaginal childbirths was associated with a significantly increased risk of stress urinary incontinence and pelvic organ prolapse surgery later in life compared with only having cesarean deliveries.