Outcomes Following Pre-marking of Episiotomy Location

NCT04719533 | Unknown

• 1 other identifier: SOR-0089-20-CTIL
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

To compare short- and long-term outcomes of women following episiotomy during the second stage of labor, following marking of episiotomy location during the first stage of labor with those of women who underwent episiotomy without marking.

Conditions

Episiotomy; Complications; Episiotomy Extended by Laceration; Episiotomy Infection

Keywords

episiotomy; episiotomy complications; premarked episiotomy

Outcome Measures

Primary Outcomes (9)

• Extended laceration of the episiotomy

  Additional perineal tears originating from the original episiotomy, as described in the birth chart

  Up to 1 hour following the episiotomy

• Third- and fourth-degree perineal tears

  Perineal tears involving the anal sphincter in addition to the episiotomy, as documented in hospital records

  Up to 2 hours following the episiotomy

• Post-partum hemorrhage

  Early (\<24 hours) or later (24 hours to 6 weeks) hemorrhage following delivery requiring physician intervention as documented in medical records

  Up to 6 weeks following delivery

• Blood transfusion requirement

  Any requirement for blood products following delivery as documented in the hospital discharge

  Up to 5 days following delivery

• Episiotomy site infection

  any documented infection of the episiotomy site treated in ambulatory or hospital setting, as recorded in medical records

  Up to 6 weeks following delivery

• Requirement of resuturing of episiotomy or evacuation of hematoma

  Any additional surgical intervention required relating to the episiotomy, as recorded in medical records

  up to 6 weeks following delivery

• Long-term symptoms related to episiotomy

  Any symptoms including perineal pain, dyspareunia, urine incontinence or fecal incontinence as reported by women using a numerical scale or dichotomic scale where appropriate

  Up to 5 years following delivery

• Perineal tears in subsequent deliveries

  As recorded in hospital records

  Up to 5 years following delivery

• Surgical correction of episiotomy

  Any additional surgical procedures required for correction of episiotomy related symptoms as recorded in medical records

  Up to 5 years following delivery

Study Arms (2)

Pre-marked episiotomy location

EXPERIMENTAL

Women in this group will undergo pre-marking of episiotomy location

Other: Pre-marking of episiotomy location

No pre-marked episiotomy location

NO INTERVENTION

Women in this group will not undergo pre-marking of episiotomy location

Interventions

Pre-marking of episiotomy location OTHER

A template marking the pre-determined correct location of episiotomy will be used to mark to women in the interventional group

Pre-marked episiotomy location

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women 18 years of age or older who present in active labour to our center and consent to participate in the study

You may not qualify if:

• women under 18 years of age or those who do not or are unable to provide informed consent to participate in the study

Sponsors & Collaborators

• Sharon Davidesko MD: lead

Study Sites (1)

Soroka University Medical Center

Beersheba, 84101, Israel

RECRUITING

Study Officials

• Sharon Davidesko, MD

  Soroka University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharon Davidesko, MD

CONTACT

+972546837362; shazadmoni85@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients' data recorded according to a coding system
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: prospective randomized-controlled trial

Study Record Dates

• First Submitted: October 2, 2020
• First Posted: January 22, 2021
• Study Start: May 17, 2021
• Primary Completion: September 24, 2025
• Study Completion: September 24, 2025
• Last Updated: October 21, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)