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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
500
A template marking the pre-determined correct location of episiotomy will be used to mark to women in the interventional group
Soroka University Medical Center
Beersheba, Israel
RECRUITINGExtended laceration of the episiotomy
Additional perineal tears originating from the original episiotomy, as described in the birth chart
Time frame: 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
Time frame: 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
Time frame: Up to 6 weeks following delivery
Blood transfusion requirement
Any requirement for blood products following delivery as documented in the hospital discharge
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 5 years following delivery
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Perineal tears in subsequent deliveries
As recorded in hospital records
Time frame: 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
Time frame: Up to 5 years following delivery