Surgical Incision Closure Method to Prevent Niche Formation After Cesarean Section- Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 183
- Locations
- 1
- Primary Endpoint
- Formation of a uterine niche
Study Overview
Brief Summary
In the last decade we have been exposed to the complication of a caesarean section called a "niche". A niche is an anaerobic defect in the location of the cesarean section, which represents the discontinuity of the endometrium and myometrium. A niche is usually diagnosed by ultrasound, and can also be diagnosed by hysterosalpingogram or hysteroscopy. In the presence of a niche women suffer more frequently from irregular bleeding, dysmenorrhea, chronic pelvic pain, and dyspareunia. We believe that a combination of tissue ischemia and thinning of the scar tissue that forms, causes a niche to form. Large randomized studies regarding the preferred surgical technique in cesarean section, including various methods of incision closure have found that there is no single method that is obviously superior. However, these studies did not examine niche formation as a complication of cesarean section.
In this study we will examine whether a unique incision closure method reduces post-cesarean niche formation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 17 Years to 50 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Women at first cesarean delivery
- •Women who consent to the study
Exclusion Criteria
- •Women who are having a repeat caesarean section
- •Refusal to participate in the study
- •Urgent or emergent cesarean delivery
Outcomes
Primary Outcomes
Formation of a uterine niche
Time Frame: At least 12 weeks after delivery.
Presence of a uterine niche on ultrasound
Secondary Outcomes
- Blood loss over 1000 mL(At surgery)
- Need for repeat laparotomy(Up to 6 weeks after intervention)
- Duration of surgery(At surgery)
- Postoperative infection(Up to 6 weeks after intervention)
- Formation of a n abscess/hematoma(Up to 6 weeks after intervention)