Clinical trial NCT04696796: Comparison of Episiotomy Scissors and BasIQ-4 Episiotomy Device in Mediolateral Episiotomy
Official title: Comparison of Episiotomy Scissors and BasIQ-4 Episiotomy Device in Mediolateral Episiotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Episiotomy Wound
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2021-01-06
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain Assessed by VAS at 48 Hours After Birth
timeFrame: 48 hours
measure: FSFI Score
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University Hospital
state: Bornova
Study officials:
References: