NCT04696796

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2021

Completed
1.7 years until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

March 2, 2023

Status Verified

March 1, 2023

Enrollment Period

1 month

First QC Date

January 4, 2021

Last Update Submit

March 1, 2023

Conditions

Episiotomy Wound

Outcome Measures

Primary Outcomes (2)

  • Pain Assessed by VAS at 48 Hours After Birth

    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.

    48 hours

  • FSFI Score

    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.

    6 months

Study Arms (2)

BasIQ-4 Surgical Knife

EXPERIMENTAL

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

Procedure: Mediolateral Episiotomy with BasIQ-4 Surgical Knife

Episiotomy Scissors

ACTIVE COMPARATOR

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

Procedure: Mediolateral Episiotomy with Episiotomy Scissors

Interventions

Mediolateral Episiotomy with BasIQ-4 Surgical KnifePROCEDURE

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

BasIQ-4 Surgical Knife
Mediolateral Episiotomy with Episiotomy ScissorsPROCEDURE

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

Episiotomy Scissors

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University Hospital

Izmir, Bornova, 35100, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 4, 2021

First Posted

January 6, 2021

Study Start

September 1, 2022

Primary Completion

October 1, 2022

Study Completion

March 1, 2023

Last Updated

March 2, 2023

Record last verified: 2023-03

Locations

TU(1)