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NCT Number: NCT04696796

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

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.

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Key information

Conditions

Episiotomy Wound

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ege University Hospital

Izmir, Bornova, 35100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Nulliparous singleton pregnancies > 37th gestational week
  • Estimated fetal weight between 3000-4000g
  • The need for an episiotomy in the second stage of labor
  • Vertex presentation

Exclusion criteria

  • Additional internal disease
  • Inability to communicate in Turkish and English
  • Multiple pregnancy
  • Episiotomies in emergency situations without crowning the baby's head
  • Using vacuum device at birth

Treatment and study plan

Mediolateral Episiotomy with BasIQ-4 Surgical Knife

Procedure

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

Mediolateral Episiotomy with Episiotomy Scissors

Procedure

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

Primary outcomes

  1. Pain Assessed by VAS at 48 Hours After Birth

    Time frame: 48 hours

    Participants will be reassessed during discharge in terms of pain with the Visual Pain Scale (VAS). The participants will asked to rate current pain on a 10-cm visual analog scale (VAS), with 0 being no pain and 10 the worst pain imaginable 48 hours after operation.

  2. FSFI Score

    Time frame: 6 months

    Participants will be requested to fill FSFI (Female Sexual Function Index) forms to evaluate their sexual lives six months after birth. The FSFI consists of 19 questions and is a validated questionnaire for the assessment of sexual function. The questions are grouped into the domains of libido, arousal, lubrication, orgasm, satisfaction, and pain. Higher scores reflect better sexual function (maximum score 36), including pain, in which 0 reflects lots of pain and 5 reflects the absence of pain.

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jan 6, 2021
Registry last updated
Mar 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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