Comparison of Episiotomy Scissors and BasIQ-4 Episiotomy Device in Mediolateral Episiotomy
Condition: Episiotomy Wound
Study type: Interventional

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.
    

Intervention name(s): Mediolateral Episiotomy with BasIQ-4 Surgical Knife; Mediolateral Episiotomy with Episiotomy Scissors
Intervention type(s): Procedure; Procedure
Intervention description(s): Mediolateral episiotomy will be performed with BasIQ-4 Surgical Knife which cuts from distal to the center with inner knife.; Mediolateral episiotomy will be made from the central to the distal with episiotomy scissors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment