An interventional study of Pre-marking of episiotomy location in Episiotomy; Complications, Episiotomy Extended by Laceration and Episiotomy Infection, sponsored by Sharon Davidesko MD. Recruiting at 1 site in Israel. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-21.
Sponsored by Sharon Davidesko MD · Not applicable, Interventional, and Prevention
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
174 studies on the registry are indexed under Lacerations; 43 are open to participants now.
This study's planned enrollment of 500 is above the median of 65 across 128 interventional studies indexed under Lacerations.
Browse Lacerations studies →This is the only study on the registry with Sharon Davidesko MD as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Women in this group will undergo pre-marking of episiotomy location
Other: Pre-marking of episiotomy location
Women in this group will not undergo pre-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
Extended 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
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
Plan to share: No — No data is to be shared with other researchers
No publications or documents are linked to this record.
Started May 2021 (actual). Primary completion is estimated for Sep 2025, 52 months after the start.
Of 46 non-industry interventional studies with no phase under Lacerations, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 72. This study's planned 52 months is above that.
Counting every sponsor, half of 50 studies reached it within 19 months; a quarter within 12 and three quarters within 72.
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