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

NCT ID: NCT04696796

Last Updated: 2023-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2023-03-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BasIQ-4 Surgical Knife

Following the administration of 10 ml of 1% lidocaine, mediolateral episiotomy will be preformed with BasIQ-4 Surgical Knife according to computer generated randomization.

Group Type: EXPERIMENTAL

Mediolateral Episiotomy with BasIQ-4 Surgical Knife

Intervention Type: PROCEDURE

Mediolateral episiotomy will be performed with BasIQ-4 Surgical Knife which cuts from distal to the center with inner knife.

Episiotomy Scissors

Following the administration of 10 ml of 1% lidocaine, mediolateral episiotomy will be preformed with episiotomy scissors according to computer generated randomization.

Group Type: ACTIVE_COMPARATOR

Mediolateral Episiotomy with Episiotomy Scissors

Intervention Type: PROCEDURE

Mediolateral episiotomy will be made from the central to the distal with episiotomy scissors

Interventions

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.

Intervention Type: PROCEDURE

Mediolateral Episiotomy with Episiotomy Scissors

Mediolateral episiotomy will be made from the central to the distal with episiotomy scissors

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Nulliparous singleton pregnancies > 37th gestational week

2. Estimated fetal weight between 3000-4000g

3. The need for an episiotomy in the second stage of labor

4. Vertex presentation

Exclusion Criteria

1. Additional internal disease

2. Inability to communicate in Turkish and English

3. Multiple pregnancy

4. Episiotomies in emergency situations without crowning the baby's head

5. Using vacuum device at birth

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ege University

OTHER

Sponsor Role: lead

Responsible Party

Sabahattin Anıl Arı

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ege University Hospital

Izmir, Bornova, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

19-9.1/45

Identifier Type: -

Identifier Source: org_study_id