Lateral Episiotomy or Not in Vacuum Assisted Delivery in Non-parous Women

NCT02643108 | Active Not Recruiting DMC

• 1 other identifier: 2015/1238-31/2
• Study Type: interventional
• Target: 717
• Locations: 1 country
• Sites: 8

Brief Summary

Nulliparous women with a live singleton pregnancy in cephalic presentation past 34 gestational weeks will be randomized to lateral episiotomy or no episiotomy when operative vaginal delivery by vacuum extraction is indicated. Primary outcome is clinically diagnosed obstetric anal sphincter injury (OASIS) of any degree.

Conditions

Pelvic Floor Disorders; Fecal Incontinence; Dystocia; Fetal Hypoxia

Keywords

Lateral episiotomy; Obstetric anal sphincter injury; Vacuum extraction; Anal incontinence

Outcome Measures

Primary Outcomes (1)

• Obstetric anal sphincter injury

  Rupture or tear of the external and/or internal anal sphincter at any degree (third and fourth degree perineal tear); International Classification of Diseases (ICD)-10 O70.2 or O70.3.

  1 hour

Secondary Outcomes (12)

• Other degree of perineal or vaginal tear

  1 hour

• Maternal blood loss at delivery

  6 hours

• Neonatal scalp injury

  24 hours

• Pain experience

  1 day, 8 weeks, 1 year

• Birthing experience

  1 day, 8 weeks

Study Arms (2)

Lateral episiotomy

EXPERIMENTAL

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.

Procedure: Lateral episiotomy

No episiotomy

NO INTERVENTION

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.

Interventions

Lateral episiotomy PROCEDURE

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.

Lateral episiotomy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Nulliparous women,18 years old or more, able to give written informed consent in Swedish or English, with a live singleton pregnancy, in a cephalic presentation over 34 completed gestational weeks with a medical indication for vacuum extraction.

You may not qualify if:

• Previous vaginal or perineal surgery for incontinence or genital prolapse, any contra-indication to vacuum extraction (ie fetal disorder or malformation).

Sponsors & Collaborators

• Karolinska Institutet: lead
• The Swedish Research Council: collaborator

Study Sites (8)

Falun Hospital

Falun, Sweden

Location

Östra Hospital Gothenburg University

Gothenburg, Sweden

Location

Helsingborg Hospital

Helsingborg, Sweden

Location

Danderyd Hospital

Stockholm, Sweden

Location

South General Hospital

Stockholm, Sweden

Location

Umeå University Hospital

Umeå, Sweden

Location

Uppsala University Hospital

Uppsala, Sweden

Location

Växjö Hospital

Vaxjo, Sweden

Location

Related Publications (8)

• 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.

  PMID: 18448735 BACKGROUND

• 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.

  PMID: 19035944 BACKGROUND

• 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.

  PMID: 22304364 BACKGROUND

• 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.

  PMID: 17999693 BACKGROUND

• 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.

  PMID: 19852569 BACKGROUND

• 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.

  PMID: 38886011 DERIVED

• 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.

  PMID: 34565424 DERIVED

• 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.

  PMID: 30872546 DERIVED

Related Links

• University based site for the trial (in Swedish)
• Swedish Network for National Clinical Studies in Obstetrics and Gynecology

MeSH Terms

Conditions

Pelvic Floor Disorders; Fecal Incontinence; Dystocia; Fetal Hypoxia; Encopresis

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Obstetric Labor Complications; Fetal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Study Officials

• Sophia Brismar Wendel, MD, PhD

  Karolinska Institutet Danderyd Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The allocation will be masked during statistical analyses.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Dept of Women's health, Danderyd Hospital

Study Record Dates

• First Submitted: December 28, 2015
• First Posted: December 30, 2015
• Study Start: June 30, 2017
• Primary Completion: February 15, 2023
• Study Completion (Estimated): December 1, 2028
• Last Updated: October 4, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When results have been published (after 1 year).
• Access Criteria: Anonymized data on the primary outcome will be shared with other researchers for a joint publication.

Locations

SE (8)