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

Randomized Controlled Clinical Trial of Lateral Episiotomy Versus no Episiotomy in Vacuum Assisted Delivery in Non-parous Women

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Dystocia; Pelvic Floor Disorders; Fecal Incontinence; Fetal Hypoxia
• Intervention / Treatment: Procedure: Lateral episiotomy

Detailed Description

The study started at Danderyd Hospital 30 June 2017. Danderyd Hospital is a large teaching hospital affiliated to Karolinska Institutet in Stockholm, Sweden. South General Hospital in Stockholm, Uppsala University Hospital, Falun Hospital, Helsingborg Hospital, Växjö Hospital, Umeå University Hospital, and Gothenburg University Hospital Östra have joined the trial 2017-2019. The trial had included 717 women of planned 710 women by 15 February 2023.

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.

• Study Type: Interventional
• Enrollment (Actual): 717
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Falun, Sweden
    • Falun hospital
  • Göteborg, Sweden
    • Östra Hospital Gothenburg University
  • Helsingborg, Sweden
    • Helsingborg Hospital
  • Stockholm, Sweden
    • Danderyd Hospital
  • Stockholm, Sweden
    • South General Hospital
  • Umeå, Sweden
    • Umeå University Hospital
  • Uppsala, Sweden
    • Uppsala University Hospital
  • Växjö, Sweden
    • Växjö Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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 Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Other degree of perineal or vaginal tear	Rupture, tear or hematoma in the perineum or vagina; International Classification of Diseases (ICD)-10 O70.0, O70.1, O70.9, O71.4-9.	1 hour
Maternal blood loss at delivery	Estimated blood loss in milliliters through weighing of sheets and drapes during and up to 6 hours after delivery.	6 hours
Neonatal scalp injury	Prevalence (number of patients) of scalp injury to the neonate after instrumental delivery, such as open wounds, cephalic hematoma, subgaleal hematoma, and intracranial hemorrhage, according to diagnose by neonatologist.	24 hours
Mode of delivery in subsequent birth	Register data will be extracted from the Swedish Pregnancy Register.	5 years and 10 years
Prevalence of obstetric anal sphincter injury in subsequent birth	Register data will be extracted from the Swedish Pregnancy Register.	5 years and 10 years
Prevalence of episiotomy in subsequent birth	Register data will be extracted from the Swedish Pregnancy Register.	5 years and 10 years
Pain experience	Numeric Rating Scale (0-10, where 0 is no pain and 10 is worst possible pain) estimated pain through questionnaire at baseline (first days post partum), 8 weeks and 12 months after delivery and at 8 weeks through questionnaires: number of days using analgetic medication.	1 day, 8 weeks, 1 year
Birthing experience	Numeric Rating Scale (1-10, where 1 is worst possible experience and 10 is best possible experience) 1-7 days postpartum, Questionnaire at 8 weeks after delivery regarding patient satisfaction using the Birth Satisfaction Scale Revised (short form) and the Childbirth Experience Questionnaire 2.0.	1 day, 8 weeks
Anal incontinence	Questionnaire at baseline, 8 weeks, 1 year, and 5 years after delivery through the Swedish Perineal Laceration Register regarding anal continence function (Wexner score based).	8 weeks, 1 year, and 5 years
Sexual function	Questionnaire at baseline (first day post partum), 1 year, and 5 years after delivery through the Swedish Obstetrical Tear Register, as well as the Female Sexual Function Index and Female Sexual Distress Score Questionnaires.	1 year and 5 years
Pelvic organ prolapse symptoms	Questionnaire at baseline, 1 year, and 5 years after delivery through the Swedish Perineal Laceration Register regarding symptoms of pelvic organ prolapse.	1 year and 5 years
Quality of life score	Assessment of quality of life by questionnaire at baseline, 1 year, and 5 years using the Euro-QoL-5D.	1 year and 5 years

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: The Swedish Research Council
• Investigators: Principal Investigator: Sophia Brismar Wendel, MD, PhD, Karolinska Institutet Danderyd Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2017
• Primary Completion (Actual): February 15, 2023
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: December 28, 2015
• First Submitted That Met QC Criteria: December 28, 2015
• First Posted (Estimated): December 30, 2015

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 1, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Anal incontinence; Lateral episiotomy; Obstetric anal sphincter injury; Vacuum extraction
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Signs and Symptoms, Respiratory; Fetal Diseases; Pregnancy Complications; Obstetric Labor Complications; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Dystocia; Hypoxia; Pelvic Floor Disorders; Fecal Incontinence; Fetal Hypoxia
• Other Study ID Numbers: 2015/1238-31/2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized data on the primary outcome will be shared with other researchers for a joint publication.
• IPD Sharing Time Frame: When results have been published (after 1 year).
• IPD Sharing Access Criteria: Anonymized data on the primary outcome will be shared with other researchers for a joint publication.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No