Isthmocele After Endometrial and Non-endometrial Suturing in Cesarean Section
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Kocaeli University
- Enrollment
- 170
- Locations
- 2
- Primary Endpoint
- Number of patients with isthmocele six month after cesarean section
Study Overview
Brief Summary
This study compares the effect of two techniques of uterine closure, with or without endometrial suturing on isthmocele development after cesarean section.
Detailed Description
Cesarean section is the most common surgery performed on pregnant women. Poor healing of the incision of the uterus leads to isthmocele development. Long-term morbidities associated with isthmocele are uterine scar pregnancy, uterine perforation, pelvic pain, and spotting-style bleeding after menstruation. Many factors that may affect the healing of uterine scar have been studied in the literature (i.e. Double or single-layer closure, locked or unlocked closure, uterine retroflection). Suturing complete fold of the wound lips during the closure of the uterus may cause the endometrial layer to be embedded in the myometrium and to form niche tissue. The study hypothesized that isthmocele development can be reduced by suturing without enclosing the endometrium during uterine closure.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Term pregnancy (≥37 weeks of gestation)
- •Singleton pregnancy
- •Primary cesarean
Exclusion Criteria
- •Previous cesarean section
- •Previous uterine surgery
- •Multiple gestations
- •Mullerian anomalies
- •Active labor
- •Placenta previa/accreta
Outcomes
Primary Outcomes
Number of patients with isthmocele six month after cesarean section
Time Frame: 6 months after intervention
Residual myometrium thickness of less then 2.5 mm with transvaginal ultrasonography
Mean myometrium thickness
Time Frame: 6 months after intervention
Myometrial thickness measured at incision site with transvaginal ultrasonography
Secondary Outcomes
- Spotting(6 months after intervention)
Investigators
Şener Gezer
Principal Investigator
Kocaeli University