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

Fecal Incontinence Clinical Trial

— EVA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02643108
• Other study ID #: 2015/1238-31/2
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 30, 2017
• Est. completion date: December 2028

Study information

• Verified date: October 2023
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 717
• Est. completion date: December 2028
• Est. primary completion date: February 15, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Dystocia
• Fecal Incontinence
• Fetal Hypoxia
• Hypoxia
• Pelvic Floor Disorders

Intervention

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.

Locations

Country	Name	City	State
Sweden	Falun Hospital	Falun
Sweden	Östra Hospital Gothenburg University	Göteborg
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	Växjö

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	The Swedish Research Council

Country where clinical trial is conducted

Sweden, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Mode of delivery in subsequent birth	Register data will be extracted from the Swedish Pregnancy Register.	5 years and 10 years
Secondary	Prevalence of obstetric anal sphincter injury in subsequent birth	Register data will be extracted from the Swedish Pregnancy Register.	5 years and 10 years
Secondary	Prevalence of episiotomy in subsequent birth	Register data will be extracted from the Swedish Pregnancy Register.	5 years and 10 years

External Links

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