Transvaginal Ultrasound Assessment of Caesarean Section Uterine Scar Closed by Single Versus Double Layer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tanta University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Uterine scar thickness
Study Overview
Brief Summary
This study aimed to evaluate uterine scar thickness and integrity using transvaginal ultrasonography in women randomly assigned to single versus double-layer closure of the uterine incision, with a comparison between the two groups.
Detailed Description
Cesarean section (CS) is one of the most commonly performed major abdominal operations in women in both high and low-income countries.
Single-layer closure using a running locking stitch is associated with decreased operative time and fewer additional haemostasis sutures. An extensive Canadian study found a fourfold increase in the risk of uterine rupture in a woman who had a single layer in their previous pregnancy.
Transvaginal ultrasound is a validated tool for evaluating uterine scar defects, commonly referred to as a niche. It is used to asses the uterine scar thickness in a women with previous cesarean delivery.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age from 20 to 40 years old.
- •Pregnant women underwent their first cesarean section.
Exclusion Criteria
- •Body mass index (BMI) ≥ 30 kg /m
- •Multiple gestations.
- •Uterine malformation.
- •Placenta previa.
- •Placenta accreta.
- •Uterine or cervical fibroid.
- •Any previous uterine operation or any medical disease that compromises wound healing, such as diabetes mellitus, collagen diseases, anemia, or corticosteroid therapy.
Arms & Interventions
Single layer group
Patients who underwent single-layer closure of the transverse lower segment during cesarean section.
Intervention: Single-layer closure (Procedure)
Double layer group
Patients who underwent double-layer closure of the transverse lower segment during cesarean section.
Intervention: Double-layer closure (Procedure)
Outcomes
Primary Outcomes
Uterine scar thickness
Time Frame: 6 months postoperatively
Uterine scar thickness was evaluated by transvaginal ultrasound six weeks, three months, and six months postoperative.
Secondary Outcomes
No secondary outcomes reported
Investigators
Said Abd El Kareem Said Saad
Resident of Obstetrics and Gynecology, Faculty of Medicine, Tanta University, Tanta, Egypt.
Tanta University