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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-11-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Transvaginal Ultrasound Caesarean Section Uterine Scar Single Layer Double Layer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single layer group

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

Group Type EXPERIMENTAL

Single-layer closure

Intervention Type PROCEDURE

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

Double layer group

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

Group Type EXPERIMENTAL

Double-layer closure

Intervention Type PROCEDURE

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

Interventions

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Single-layer closure

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

Intervention Type PROCEDURE

Double-layer closure

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No