Episiotomy; Complications, Episiotomy Extended by Laceration, Episiotomy Infection
Conditions
Keywords
episiotomy, episiotomy complications, premarked episiotomy
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
Interventions
OTHERPre-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
Sponsors
Sharon Davidesko MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Patients' data recorded according to a coding system
Intervention model description
prospective randomized-controlled trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perineal tears in subsequent deliveries | Up to 5 years following delivery | As recorded 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Blood transfusion requirement | Up to 5 days following delivery | Any requirement for blood products following delivery as documented in the hospital discharge |
| 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 |
| 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 |
Countries
Israel
Contacts
Primary ContactSharon Davidesko, MD
Outcome results
None listed