Comparing outcomes of marked versus unmarked episiotomy during labor
Short and Long Term Outcomes of Patients With and Without Pre-marked Episiotomy Location
This study is testing whether marking the spot for an episiotomy before it's done can help reduce complications for women in labor.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Soroka University Medical Center Academic / other |
| Locations | 1 site (Be'er Sheva) |
| Trial ID | NCT04719533 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the short- and long-term outcomes for women who undergo episiotomy during the second stage of labor, specifically comparing those who have the episiotomy location marked beforehand to those who do not. It is a prospective randomized-controlled trial designed to test the hypothesis that pre-marking the episiotomy location will lead to fewer complications. Participants will be women aged 18 and older who are in active labor and consent to the study. The outcomes will focus on complications related to episiotomy, including infections and extended lacerations.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 and older who are in active labor and can provide informed consent.
Not a fit: Patients who are under 18 years of age or unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce complications associated with episiotomy, improving recovery and overall maternal health.
How similar studies have performed: There is limited existing research on the pre-marking of episiotomy locations, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Be'er Sheva
- Soroka University Medical Center — Be'er Sheva, Israel (Recruiting)
Study contacts
- Principal investigator: Sharon Davidesko, MD — Soroka University Medical Center
- Study coordinator: Sharon Davidesko, MD
- Email: shazadmoni85@gmail.com
- Phone: +972546837362
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.