Lateral Episiotomy or Not in Vacuum Assisted Delivery in Non-parous Women
NCT ID: NCT02643108
Last Updated: 2023-10-04
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
717 participants
INTERVENTIONAL
2017-06-30
2028-12-31
Brief Summary
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Detailed Description
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Informed consent was collected from nulliparous women with a singelton, live fetus in cephalic presentation, with a planned vaginal delivery and without previous gynecological surgery for incontinence or genital prolapse. Women were approached at any time from gestational week 18 until delivery, unless they were in severe pain or discomfort, or there was not enough time to consider the information, or any other reason not to obtain consent. The informed consent forms are kept at the receiving research department and a note of consent/no consent was made in the obstetric medical record.
At indication for vacuum extraction, the patient's consent was confirmed verbally and allocation was made via sealed opaque envelopes on the vacuum extraction equipment mobile cart. Randomization was performed 1:1 in random permuted blocks generated electronically by an external organization (Karolinska Trial Alliance).
Lateral episiotomy was performed according to the intervention description. A reduction of OASIS from 12.4% to 6.2% can be detected with 80% power and less than 5% risk of alpha-error (p\<0.05) with 355 women in each group using Chi-square test comparing two independent proportions in a two-sided test (3% missing outcome). A smaller reduction is clinically valuable, although the risk-benefit relationship between receiving a prophylactic episiotomy and the chance of an intact perineum may limit the feasibility of a larger trial in a setting with a restrictive episiotomy policy. We have obtained ethical approval to randomise a total of 1400 women, which enables us to detect a reduction in OASIS rate at VE from 12.4% to 7.8% (p\<0.05). We planned and performed an interim analysis in order to exclude an unethically large difference (p\<0.01) at 350 randomised women. The stopping criteria were not met. In 2019, we decided to aim for 710 randomised women due to slow recruitment.
Data was collected prospectively through Case Record Forms and the obstetric medical record Obstetrix (Cerner Sverige AB), which covers approximately 98% of deliveries with complete data, and the Swedish Pregnancy Register covering 98% of births in Sweden from 2015. Using a weblink, questionnaires from the national Obstetric Perineal Tear Register, are sent out electronically for the follow-up of study participants. In addition, questionnaires regarding birth satisfaction/experience (BSS-R and CEQ 2.0) are sent at 8 weeks after delivery. Questionnaires regarding sexual function (FSFI and FSDS) and quality of life (Euro-QoL-5D) at delivery and after 12 months.
A follow-up from registers regarding mode of delivery and prevalence of episiotomy and OASIS in subsequent births will be performed at 5 years and 10 years after the index birth.
A substudy takes place in Stockholm, Uppsala, and Helsingborg, where randomised women are examined at 6-12 months after delivery with 3D endovaginal and endoanal ultrasound to detect levator and sphincter injuries, measure episiotomy scars, establish POP-Q scores, and evaluate a new questionnaire for pelvic floor function after perineal tears.
Another substudy has taken place in Stockholm and Falun, where women who have been asked for consent (both affirmative and non-affirmative responders), as well as midwives who have tried to obtain consent, were invited to a qualitative interview study to explore the recruitment experience of women and midwives.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Lateral episiotomy
Lateral episiotomy (left or right) is performed by the attending physician or assisting midwife at crowning of the fetal head in operative vaginal delivery by vacuum extraction. Regular manual perineal support is applied.
Lateral episiotomy
When the woman is randomized to episiotomy, lateral episiotomy is performed with scissors on the left or right side of the vaginal opening. Origin of incision is 1.0 - 3.0 cm from the midline/posterior forchette and is cut 3.0 cm or more towards the ischial tuberosity at an angle of 60 degrees from the midline.
No episiotomy
No episiotomy is performed during operative vaginal delivery, unless vitally indicated (for example severe fetal distress). The woman may tear spontaneously. Regular manual perineal support is applied.
No interventions assigned to this group
Interventions
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Lateral episiotomy
When the woman is randomized to episiotomy, lateral episiotomy is performed with scissors on the left or right side of the vaginal opening. Origin of incision is 1.0 - 3.0 cm from the midline/posterior forchette and is cut 3.0 cm or more towards the ischial tuberosity at an angle of 60 degrees from the midline.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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The Swedish Research Council
OTHER_GOV
Karolinska Institutet
OTHER
Responsible Party
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Sophia Brismar Wendel
MD, PhD, Dept of Women's health, Danderyd Hospital
Principal Investigators
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Sophia Brismar Wendel, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet Danderyd Hospital
Locations
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Falun Hospital
Falun, , Sweden
Östra Hospital Gothenburg University
Gothenburg, , Sweden
Helsingborg Hospital
Helsingborg, , Sweden
Danderyd Hospital
Stockholm, , Sweden
South General Hospital
Stockholm, , Sweden
Umeå University Hospital
Umeå, , Sweden
Uppsala University Hospital
Uppsala, , Sweden
Växjö Hospital
Vaxjo, , Sweden
Countries
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References
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Laine K, Pirhonen T, Rolland R, Pirhonen J. Decreasing the incidence of anal sphincter tears during delivery. Obstet Gynecol. 2008 May;111(5):1053-7. doi: 10.1097/AOG.0b013e31816c4402.
Murphy DJ, Macleod M, Bahl R, Goyder K, Howarth L, Strachan B. A randomised controlled trial of routine versus restrictive use of episiotomy at operative vaginal delivery: a multicentre pilot study. BJOG. 2008 Dec;115(13):1695-702; discussion 1702-3. doi: 10.1111/j.1471-0528.2008.01960.x.
Kalis V, Laine K, de Leeuw JW, Ismail KM, Tincello DG. Classification of episiotomy: towards a standardisation of terminology. BJOG. 2012 Apr;119(5):522-6. doi: 10.1111/j.1471-0528.2011.03268.x. Epub 2012 Feb 3.
de Leeuw JW, de Wit C, Kuijken JP, Bruinse HW. Mediolateral episiotomy reduces the risk for anal sphincter injury during operative vaginal delivery. BJOG. 2008 Jan;115(1):104-8. doi: 10.1111/j.1471-0528.2007.01554.x. Epub 2007 Nov 12.
Raisanen SH, Vehvilainen-Julkunen K, Gissler M, Heinonen S. Lateral episiotomy protects primiparous but not multiparous women from obstetric anal sphincter rupture. Acta Obstet Gynecol Scand. 2009;88(12):1365-72. doi: 10.3109/00016340903295626.
Bergendahl S, Jonsson M, Hesselman S, Ankarcrona V, Leijonhufvud A, Wihlback AC, Wallstrom T, Rydstrom E, Friberg H, Kopp Kallner H, Brismar Wendel S. Lateral episiotomy or no episiotomy in vacuum assisted delivery in nulliparous women (EVA): multicentre, open label, randomised controlled trial. BMJ. 2024 Jun 17;385:e079014. doi: 10.1136/bmj-2023-079014.
Ericson J, Anagrius C, Rygaard A, Guntram L, Wendel SB, Hesselman S. Women's experiences of receiving information about and consenting or declining to participate in a randomized controlled trial involving episiotomy in vacuum-assisted delivery: a qualitative study. Trials. 2021 Sep 26;22(1):658. doi: 10.1186/s13063-021-05624-8.
Bergendahl S, Ankarcrona V, Leijonhufvud A, Hesselman S, Karlstrom S, Kopp Kallner H, Brismar Wendel S. 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. BMJ Open. 2019 Mar 13;9(3):e025050. doi: 10.1136/bmjopen-2018-025050.
Provided Documents
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Document Type: Study Protocol
Related Links
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University based site for the trial (in Swedish)
Swedish Network for National Clinical Studies in Obstetrics and Gynecology
Other Identifiers
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2015/1238-31/2
Identifier Type: -
Identifier Source: org_study_id
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