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Outcomes Following Pre-marking of Episiotomy Location

S

Sharon Davidesko MD

Status

Enrolling

Conditions

Episiotomy; Complications
Episiotomy Infection
Episiotomy Extended by Laceration

Treatments

Other: Pre-marking of episiotomy location

Study type

Interventional

Funder types

Other

Identifiers

NCT04719533
SOR-0089-20-CTIL

Details and patient eligibility

About

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.

Full 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

Enrollment

500 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

500 participants in 2 patient groups

Pre-marked episiotomy location
Experimental group
Description:
Women in this group will undergo pre-marking of episiotomy location
Treatment:
Other: Pre-marking of episiotomy location
No pre-marked episiotomy location
No Intervention group
Description:
Women in this group will not undergo pre-marking of episiotomy location

Trial contacts and locations

1

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Central trial contact

Sharon Davidesko, MD

Data sourced from clinicaltrials.gov

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