Ultrasound Evaluation of Cesarean Scar After Uterotomy Closure With Barbed and Conventional Sutures ; a Randomized Controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Cairo University
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Residual myometrial thickness
Study Overview
Brief Summary
The aim of this randomized control trial is to compare the residual myometrial thickness and the depth of cesarean section scar defect after uterine incision closure with barbed or conventional sutures.
Detailed Description
The aim of this randomized control trial is to compare the residual myometrial thickness and the depth of cesarean section scar defect after uterine incision closure with barbed or conventional sutures. Primigravida patients undergoing transverse lower segment cesarean section will be included in the study.Cesarean section incision will be closed with double layers of continuous barbed or conventional sutures. Ultrasound examination will be performed 6 months after the operation to measure the residual myometrial thickness and the scar depth.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Primigravida patients undergoing transverse lower segment cesarean section
Exclusion Criteria
- •Previous laparotomies
- •Postoperative fever
- •Patients with preterm pregnancies or in labor
Arms & Interventions
Cesarean section incision closure using barbed sutures
Cesarean section incision is closed using barbed sutures
Intervention: Cesarean section incision closure using barbed sutures (Device)
Cesarean section incision closure using conventional sutures
Cesarean section incision is closed using conventional sutures
Intervention: Cesarean section incision closure using conventional sutures (Device)
Outcomes
Primary Outcomes
Residual myometrial thickness
Time Frame: Six months after cesarean section
Thickness of myometrium under the niche
Secondary Outcomes
- Scar depth(Six months after cesarean section)
Investigators
Usama M Fouda
Prof.
Cairo University