Outcomes Following Pre-marking of Episiotomy Location
Primary Purpose
Episiotomy; Complications, Episiotomy Extended by Laceration, Episiotomy Infection
Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Pre-marking of episiotomy location
Sponsored by
About this trial
This is an interventional prevention trial for Episiotomy; Complications focused on measuring episiotomy, episiotomy complications, premarked episiotomy
Eligibility Criteria
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
Sites / Locations
- Soroka University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Pre-marked episiotomy location
No pre-marked episiotomy location
Arm Description
Women in this group will undergo pre-marking of episiotomy location
Women in this group will not undergo pre-marking of episiotomy location
Outcomes
Primary Outcome Measures
Extended laceration of the episiotomy
Additional perineal tears originating from the original episiotomy, as described in the birth chart
Third- and fourth-degree perineal tears
Perineal tears involving the anal sphincter in addition to the episiotomy, as documented in hospital records
Post-partum hemorrhage
Early (<24 hours) or later (24 hours to 6 weeks) hemorrhage following delivery requiring physician intervention as documented in medical records
Blood transfusion requirement
Any requirement for blood products following delivery as documented in the hospital discharge
Episiotomy site infection
any documented infection of the episiotomy site treated in ambulatory or hospital setting, as recorded in medical records
Requirement of resuturing of episiotomy or evacuation of hematoma
Any additional surgical intervention required relating to the episiotomy, as recorded in medical records
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
Perineal tears in subsequent deliveries
As recorded in hospital records
Surgical correction of episiotomy
Any additional surgical procedures required for correction of episiotomy related symptoms as recorded in medical records
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04719533
Brief Title
Outcomes Following Pre-marking of Episiotomy Location
Official Title
Short and Long Term Outcomes of Patients With and Without Pre-marked Episiotomy Location
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 17, 2021 (Actual)
Primary Completion Date
September 24, 2025 (Anticipated)
Study Completion Date
September 24, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sharon Davidesko MD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Episiotomy; Complications, Episiotomy Extended by Laceration, Episiotomy Infection
Keywords
episiotomy, episiotomy complications, premarked episiotomy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective randomized-controlled trial
Masking
Participant
Masking Description
Patients' data recorded according to a coding system
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pre-marked episiotomy location
Arm Type
Experimental
Arm Description
Women in this group will undergo pre-marking of episiotomy location
Arm Title
No pre-marked episiotomy location
Arm Type
No Intervention
Arm Description
Women in this group will not undergo pre-marking of episiotomy location
Intervention Type
Other
Intervention Name(s)
Pre-marking of episiotomy location
Intervention Description
A template marking the pre-determined correct location of episiotomy will be used to mark to women in the interventional group
Primary Outcome Measure Information:
Title
Extended laceration of the episiotomy
Description
Additional perineal tears originating from the original episiotomy, as described in the birth chart
Time Frame
Up to 1 hour following the episiotomy
Title
Third- and fourth-degree perineal tears
Description
Perineal tears involving the anal sphincter in addition to the episiotomy, as documented in hospital records
Time Frame
Up to 2 hours following the episiotomy
Title
Post-partum hemorrhage
Description
Early (<24 hours) or later (24 hours to 6 weeks) hemorrhage following delivery requiring physician intervention as documented in medical records
Time Frame
Up to 6 weeks following delivery
Title
Blood transfusion requirement
Description
Any requirement for blood products following delivery as documented in the hospital discharge
Time Frame
Up to 5 days following delivery
Title
Episiotomy site infection
Description
any documented infection of the episiotomy site treated in ambulatory or hospital setting, as recorded in medical records
Time Frame
Up to 6 weeks following delivery
Title
Requirement of resuturing of episiotomy or evacuation of hematoma
Description
Any additional surgical intervention required relating to the episiotomy, as recorded in medical records
Time Frame
up to 6 weeks following delivery
Title
Long-term symptoms related to episiotomy
Description
Any symptoms including perineal pain, dyspareunia, urine incontinence or fecal incontinence as reported by women using a numerical scale or dichotomic scale where appropriate
Time Frame
Up to 5 years following delivery
Title
Perineal tears in subsequent deliveries
Description
As recorded in hospital records
Time Frame
Up to 5 years following delivery
Title
Surgical correction of episiotomy
Description
Any additional surgical procedures required for correction of episiotomy related symptoms as recorded in medical records
Time Frame
Up to 5 years following delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sharon Davidesko, MD
Phone
+972546837362
Email
shazadmoni85@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon Davidesko, MD
Organizational Affiliation
Soroka University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soroka University Medical Center
City
Be'er Sheva
ZIP/Postal Code
84101
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharon Davidesko, MD
Phone
+972546837362
Email
shazadmoni85@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No data is to be shared with other researchers
Learn more about this trial
Outcomes Following Pre-marking of Episiotomy Location
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