Outcomes Following Pre-marking of Episiotomy Location

Episiotomy; Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04719533
• Other study ID #: SOR-0089-20-CTIL
• Status: Recruiting
• Phase: N/A
• Start date: May 17, 2021
• Est. completion date: September 24, 2025

Study information

• Verified date: October 2021
• Source: Soroka University Medical Center
• Contact: Sharon Davidesko, MD
• Phone: +972546837362
• Email: shazadmoni85[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: September 24, 2025
• Est. primary completion date: September 24, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Episiotomy Extended by Laceration
• Episiotomy Infection
• Episiotomy; Complications
• Lacerations

Intervention

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

Locations

Country	Name	City	State
Israel	Soroka University Medical Center	Be'er Sheva

Sponsors (1)

Lead Sponsor	Collaborator
Sharon Davidesko MD

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Blood transfusion requirement	Any requirement for blood products following delivery as documented in the hospital discharge	Up to 5 days following delivery
Primary	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
Primary	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
Primary	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
Primary	Perineal tears in subsequent deliveries	As recorded in hospital records	Up to 5 years following delivery
Primary	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