Outcomes Following Pre-marking of Episiotomy Location

Not Applicable

Recruiting

• Conditions: Episiotomy; Complications; Episiotomy Extended by Laceration; Episiotomy Infection
• Interventions: Other: Pre-marking of episiotomy location

• Registration Number: NCT04719533
• Lead Sponsor: Sharon Davidesko MD

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.

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 Timeline

• Study First Submitted: 2020-10-02
• Study First Submitted QC: 2021-01-20
• Study First Posted: 2021-01-22
• Study Start: 2021-05-17
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-13
• Last Update Posted: 2021-10-21
• Primary Completion: 2025-09-24
• Study Completion: 2025-09-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pre-marked episiotomy location	Pre-marking of episiotomy location	Women in this group will undergo pre-marking of episiotomy location

Primary Outcome Measures

Name	Time	Method
Third- and fourth-degree perineal tears	Up to 2 hours following the episiotomy	Perineal tears involving the anal sphincter in addition to the episiotomy, as documented in hospital records
Requirement of resuturing of episiotomy or evacuation of hematoma	up to 6 weeks following delivery	Any additional surgical intervention required relating to the episiotomy, as recorded in medical records
Blood transfusion requirement	Up to 5 days following delivery	Any requirement for blood products following delivery as documented in the hospital discharge
Post-partum hemorrhage	Up to 6 weeks following delivery	Early (\<24 hours) or later (24 hours to 6 weeks) hemorrhage following delivery requiring physician intervention as documented in medical records
Long-term symptoms related to episiotomy	Up to 5 years following delivery	Any symptoms including perineal pain, dyspareunia, urine incontinence or fecal incontinence as reported by women using a numerical scale or dichotomic scale where appropriate
Perineal tears in subsequent deliveries	Up to 5 years following delivery	As recorded in hospital records
Surgical correction of episiotomy	Up to 5 years following delivery	Any additional surgical procedures required for correction of episiotomy related symptoms as recorded in medical records
Extended laceration of the episiotomy	Up to 1 hour following the episiotomy	Additional perineal tears originating from the original episiotomy, as described in the birth chart
Episiotomy site infection	Up to 6 weeks following delivery	any documented infection of the episiotomy site treated in ambulatory or hospital setting, as recorded in medical records

Trial Locations

Locations (1)

Soroka University Medical Center; 🇮🇱 Be'er Sheva, Israel