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Transvaginal Ultrasound Assessment of Caesarean Section Uterine Scar Closed by Single Versus Double Layer

Transvaginal Ultrasound Assessment of Caesarean Section Uterine Scar Closed by Single Versus Double Layer

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07074522
Enrollment
60
Registered
2025-07-20
Start date
2023-12-01
Completion date
2024-11-01
Last updated
2025-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caesarean Section, Double Layer, Single Layer, Transvaginal Ultrasound, Uterine Scar

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.

Interventions

PROCEDURESingle-layer closure

Patients who underwent single-layer closure of the transverse lower segment during cesarean section.

PROCEDUREDouble-layer closure

Patients who underwent double-layer closure of the transverse lower segment during cesarean section.

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
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 /m2. * 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.

Design outcomes

Primary

MeasureTime frameDescription
Uterine scar thickness6 months postoperativelyUterine scar thickness was evaluated by transvaginal ultrasound six weeks, three months, and six months postoperative.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026