Outcomes Following Pre-marking of Episiotomy Location

Short and Long Term Outcomes of Patients With and Without Pre-marked Episiotomy Location

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.

Study Overview

• Status: Recruiting
• Conditions: Episiotomy; Complications; Episiotomy Extended by Laceration; Episiotomy Infection
• Intervention / Treatment: Other: Pre-marking of episiotomy location

Detailed Description

Purpose: 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.

Hypothesis: Women following episiotomy following pre-marking of the location will suffer from fewer short- and long-term complications compared to those without pre-marked episiotomy location.

Study type: prospective randomized-controlled trial

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sharon Davidesko, MD; Phone Number: +972546837362; Email: shazadmoni85@gmail.com

Study Locations

• Israel
  • Be'er Sheva, Israel, 84101
    • Recruiting
    • Soroka University Medical Center
    • Contact: Sharon Davidesko, MD; Phone Number: +972546837362; Email: shazadmoni85@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pre-marked episiotomy location; Women in this group will undergo pre-marking of episiotomy location	Other: Pre-marking of episiotomy location; A template marking the pre-determined correct location of episiotomy will be used to mark to women in the interventional group
No Intervention: No pre-marked episiotomy location; Women in this group will not undergo pre-marking of episiotomy location

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sharon Davidesko MD
• Investigators: Principal Investigator: Sharon Davidesko, MD, Soroka University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2021
• Primary Completion (Anticipated): September 24, 2025
• Study Completion (Anticipated): September 24, 2025

Study Registration Dates

• First Submitted: October 2, 2020
• First Submitted That Met QC Criteria: January 20, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): October 21, 2021
• Last Update Submitted That Met QC Criteria: October 13, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: episiotomy; episiotomy complications; premarked episiotomy
• Additional Relevant MeSH Terms: Wounds and Injuries; Lacerations
• Other Study ID Numbers: SOR-0089-20-CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No data is to be shared with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No