NCT04696796

Comparison of Episiotomy Scissors and BasIQ-4 Episiotomy Device in Mediolateral Episiotomy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Ege University · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Episiotomy is an obstetric intervention performed to facilitate, accelerate and / or prevent third and fourth degree perineal tears by cutting the vagina at the end of the second stage of labor. Postpartum perineal pain affects patients' lives significantly and causes negative effects on work life, social life and family relations. Median episiotomy is associated with 3-4 times increased anal sphincter injury as well as easy recovery. Therefore, mediolateral episiotomy is preferred in Europe. The common feature was that scissors are used in previous studies and the incision was made from the central to the distal. A randomized controlled clinical study is planned to compare the scissors and episiotomy device BasIQ-4, which carries scalpel, holding apparatus, and cuts from distal to the center in mediolateral episiotomy. This is the first study in humans in this field.

Detailed description

Pregnant women who applied to Ege University Gynecology and Obstetrics Department Delivery Room Service and had vaginal delivery will be included in the study after obtaining their consent. When the cases meeting the inclusion criteria will be taken to the delivery table for delivery, verbal consent will be obtained by the physician if the need for episiotomy is determined by the physician in the second stage of delivery. Following the administration of 10 ml of 1% lidocaine, mediolateral episiotomy will be opened with scissors or Basiq-4 according to computer generated randomization. The presence of shoulder dystocia during delivery, the number of moves for episiotomy incision, the duration of stage 2, fetal weight, the degree of perineal injury, any additional injury, and urethral injury will be recorded in the prepared case form. Then, the episiotomy incision will be continuously sutured with 2-0 slow dissolving polyglactin 910 suture material for all cases. The length of episiotomy after suturing and the length of perineal injury, if any, will be measured with a sterile ruler and recorded on the case form. Postpartum discharge is carried out 48 hours after birth in accordance with the Ministry of Health Regulations. Participants will be reassessed during discharge in terms of pain with the Visual Pain Scale (VAS). The cases will be evaluated by the study team again, and notes regarding episiotomy length, infection, pain, incision separation, fecal incontinence, rectovaginal fistula, and painful defecation will be recorded on the case form six months after delivery. Participants will be requested to fill FSFI forms to evaluate their sexual lives.

Conditions

• Episiotomy Wound

Interventions

Type	Name	Description
PROCEDURE	Mediolateral Episiotomy with BasIQ-4 Surgical Knife	Mediolateral episiotomy will be performed with BasIQ-4 Surgical Knife which cuts from distal to the center with inner knife.
PROCEDURE	Mediolateral Episiotomy with Episiotomy Scissors	Mediolateral episiotomy will be made from the central to the distal with episiotomy scissors

Timeline

• Start date: 2022-09-01
• Primary completion: 2022-10-01
• Completion: 2023-03-01
• First posted: 2021-01-06
• Last updated: 2023-03-02

Locations

1 site across 1 country: Turkey (Türkiye)