Outcomes Following Pre-marking of Episiotomy Location

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Episiotomy; Complications, Episiotomy Extended by Laceration, Episiotomy Infection

Intervention / Treatment
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* Other: Pre-marking of episiotomy location


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective randomized-controlled trial
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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episiotomy, episiotomy complications, premarked episiotomy