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

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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

Bergendahl, Sandra (författare): Karolinska Institutet,Karolinska Institute,Karolinska Inst, Dept Clin Sci, Stockholm, Sweden

Ankarcrona, Victoria (författare): Karolinska Institute,Karolinska Inst, Dept Clin Sci, Stockholm, Sweden

Leijonhufvud, Åsa (författare): Lund University,Lunds universitet,Kliniska Vetenskaper, Helsingborg,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Clinical Sciences, Helsingborg,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine,Lund Univ, Clin Sci Helsingborg, Dept Clin Sci Lund, Lund, Sweden

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Hesselman, Susanne, 1973- (författare): Uppsala universitet,Uppsala University,Falun Central Hospital,Klinisk obstetrik,Centrum för klinisk forskning Dalarna

Karlström, Sofie (författare): Karolinska Institute,Karolinska Inst, Dept Clin Sci Intervent & Technol, Stockholm, Sweden

Kopp Kallner, Helena (författare): Karolinska Institutet,Karolinska Institute,Karolinska Inst, Dept Womens & Childrens Hlth, Stockholm, Sweden

Brismar Wendel, Sophia (författare): Karolinska Institute,Karolinska Inst, Dept Clin Sci, Stockholm, Sweden

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2019-03-13
2019
Engelska.
Ingår i: BMJ Open. - : BMJ. - 2044-6055. ; 9:3

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Abstract Ämnesord

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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.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Reproduktionsmedicin och gynekologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Obstetrics, Gynaecology and Reproductive Medicine (hsv//eng)

Nyckelord

lateral episiotomy
obstetric anal sphincter injury
pelvic floor ultrasound
randomised controlled trial
vacuum extraction

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Av författaren/redakt...: Bergendahl, Sand ...; Ankarcrona, Vict ...; Leijonhufvud, Ås ...; Hesselman, Susan ...; Karlström, Sofie; Kopp Kallner, He ...; visa fler...; Brismar Wendel, ...; visa färre...

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MEDICIN OCH HÄLSOVETENSKAP: MEDICIN OCH HÄLS ...; och Klinisk medicin; och Reproduktionsmed ...

Artiklar i publikationen: BMJ Open

Av lärosätet: Lunds universitet; Karolinska Institutet; Uppsala universitet

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