Lateral Episiotomy or Not in Vacuum Assisted Delivery in Non-parous Women (EVA)
Primary Purpose
Pelvic Floor Disorders, Fecal Incontinence, Dystocia
Status
Active
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Lateral episiotomy
Sponsored by
About this trial
This is an interventional prevention trial for Pelvic Floor Disorders focused on measuring Lateral episiotomy, Obstetric anal sphincter injury, Vacuum extraction, Anal incontinence
Eligibility Criteria
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 of 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).
Sites / Locations
- Falun Hospital
- Östra Hospital Gothenburg University
- Helsingborg Hospital
- Danderyd Hospital
- South General Hospital
- Umeå University Hospital
- Uppsala University Hospital
- Växjö Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Lateral episiotomy
No episiotomy
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Maternal blood loss at delivery
Estimated blood loss in milliliters through weighing of sheets and drapes during and up to 6 hours after delivery.
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.
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.
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.
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).
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.
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.
Quality of life score
Assessment of quality of life by questionnaire at baseline, 1 year, and 5 years using the Euro-QoL-5D.
Mode of delivery in subsequent birth
Register data will be extracted from the Swedish Pregnancy Register.
Prevalence of obstetric anal sphincter injury in subsequent birth
Register data will be extracted from the Swedish Pregnancy Register.
Prevalence of episiotomy in subsequent birth
Register data will be extracted from the Swedish Pregnancy Register.
Full Information
NCT ID
NCT02643108
First Posted
December 28, 2015
Last Updated
October 1, 2023
Sponsor
Karolinska Institutet
Collaborators
The Swedish Research Council
1. Study Identification
Unique Protocol Identification Number
NCT02643108
Brief Title
Lateral Episiotomy or Not in Vacuum Assisted Delivery in Non-parous Women
Acronym
EVA
Official Title
Randomized Controlled Clinical Trial of Lateral Episiotomy Versus no Episiotomy in Vacuum Assisted Delivery in Non-parous Women
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 30, 2017 (Actual)
Primary Completion Date
February 15, 2023 (Actual)
Study Completion Date
December 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
The Swedish Research Council
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Floor Disorders, Fecal Incontinence, Dystocia, Fetal Hypoxia
Keywords
Lateral episiotomy, Obstetric anal sphincter injury, Vacuum extraction, Anal incontinence
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
The allocation will be masked during statistical analyses.
Allocation
Randomized
Enrollment
717 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lateral episiotomy
Arm Type
Experimental
Arm Description
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.
Arm Title
No episiotomy
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Lateral episiotomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Obstetric anal sphincter injury
Description
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.
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Other degree of perineal or vaginal tear
Description
Rupture, tear or hematoma in the perineum or vagina; International Classification of Diseases (ICD)-10 O70.0, O70.1, O70.9, O71.4-9.
Time Frame
1 hour
Title
Maternal blood loss at delivery
Description
Estimated blood loss in milliliters through weighing of sheets and drapes during and up to 6 hours after delivery.
Time Frame
6 hours
Title
Neonatal scalp injury
Description
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.
Time Frame
24 hours
Title
Pain experience
Description
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.
Time Frame
1 day, 8 weeks, 1 year
Title
Birthing experience
Description
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.
Time Frame
1 day, 8 weeks
Title
Anal incontinence
Description
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).
Time Frame
8 weeks, 1 year, and 5 years
Title
Sexual function
Description
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.
Time Frame
1 year and 5 years
Title
Pelvic organ prolapse symptoms
Description
Questionnaire at baseline, 1 year, and 5 years after delivery through the Swedish Perineal Laceration Register regarding symptoms of pelvic organ prolapse.
Time Frame
1 year and 5 years
Title
Quality of life score
Description
Assessment of quality of life by questionnaire at baseline, 1 year, and 5 years using the Euro-QoL-5D.
Time Frame
1 year and 5 years
Title
Mode of delivery in subsequent birth
Description
Register data will be extracted from the Swedish Pregnancy Register.
Time Frame
5 years and 10 years
Title
Prevalence of obstetric anal sphincter injury in subsequent birth
Description
Register data will be extracted from the Swedish Pregnancy Register.
Time Frame
5 years and 10 years
Title
Prevalence of episiotomy in subsequent birth
Description
Register data will be extracted from the Swedish Pregnancy Register.
Time Frame
5 years and 10 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophia Brismar Wendel, MD, PhD
Organizational Affiliation
Karolinska Institutet Danderyd Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Falun Hospital
City
Falun
Country
Sweden
Facility Name
Östra Hospital Gothenburg University
City
Göteborg
Country
Sweden
Facility Name
Helsingborg Hospital
City
Helsingborg
Country
Sweden
Facility Name
Danderyd Hospital
City
Stockholm
Country
Sweden
Facility Name
South General Hospital
City
Stockholm
Country
Sweden
Facility Name
Umeå University Hospital
City
Umeå
Country
Sweden
Facility Name
Uppsala University Hospital
City
Uppsala
Country
Sweden
Facility Name
Växjö Hospital
City
Växjö
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
18448735
Citation
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.
Results Reference
background
PubMed Identifier
19035944
Citation
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.
Results Reference
background
PubMed Identifier
22304364
Citation
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.
Results Reference
background
PubMed Identifier
17999693
Citation
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.
Results Reference
background
PubMed Identifier
19852569
Citation
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.
Results Reference
background
PubMed Identifier
34565424
Citation
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.
Results Reference
derived
PubMed Identifier
30872546
Citation
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.
Results Reference
derived
Links:
URL
https://ki.se/kids/eva-studien
Description
University based site for the trial (in Swedish)
URL
https://www.snaks.se/en/start/
Description
Swedish Network for National Clinical Studies in Obstetrics and Gynecology
Learn more about this trial
Lateral Episiotomy or Not in Vacuum Assisted Delivery in Non-parous Women
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