Diagnostic Accuracy of Saline Sonohystrography vs. 3D Transvaginal Ultrasound for Cesarean Scar Defect Assessment

NCT05996926 | Unknown

• 1 other identifier: FMASU MD25/2021
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

To compare accuracy of three dimensional transvaginal ultrasound versus the "gold standard" saline infused sonography for assessing the characteristics, frequency and appearance of caesarean scar defects in symptomatic patients with a history of cesarean section.

Conditions

Cesarean Scar Defects; Cesarean Section Complications; Uterine Scar Dehiscence; Vaginal Birth After Cesarean; Abnormal Uterine Bleeding

Outcome Measures

Primary Outcomes (2)

• Diagnostic Accuracy of Cesarean Scar Defect Assessment Using 3D TVS

  This outcome measure aims to evaluate the diagnostic accuracy of three-dimensional transvaginal ultrasound (3D TVS) as measurement tools in assessing Cesarean Scar Defects (CSD) and associated complications among symptomatic patients with a history of cesarean section. The assessment will involve identifying, classifying, and measuring Cesarean Scar Defects (CSD) characteristics using these specific measurement techniques.

  Intraoperatively

• Diagnostic Accuracy of Cesarean Scar Defect Assessment Using Saline-Infused Sonography

  This outcome measure aims to evaluate the diagnostic accuracy of saline-infused sonography (Sonohystrography) as measurement tools in assessing Cesarean Scar Defects (CSD) and associated complications among symptomatic patients with a history of cesarean section. The assessment will involve identifying, classifying, and measuring Cesarean Scar Defects (CSD) characteristics using these specific measurement techniques.

  Intraoperatively

Study Arms (2)

Three-Dimensional Transvaginal Ultrasound (3D TVS)

EXPERIMENTAL

In this study, Three-Dimensional Transvaginal Ultrasound will be employed as one of the interventions to evaluate Cesarean Scar Defects (CSD) and associated complications in symptomatic patients with a history of cesarean section. A specialized ultrasound machine (Samsung WS80A) equipped with a transvaginal 2-11 MHz probe will be used for the Three-Dimensional Transvaginal Ultrasound examination. The examination will be conducted in the 1st half of the menstrual cycle. The ultrasound probe will be introduced into the posterior fornix of the vagina to capture three-dimensional images of the uterus and scar area. The examiner will identify and measure the characteristics of the Cesarean Scar Defects (CSD), including length, depth, width, volume, residual myometrial thickness, adjacent myometrial thickness, and presence of any branches.

Diagnostic Test: Three-Dimensional Transvaginal Ultrasound (3D TVS)

Saline-Infused Sonography (Sonohystrography)

EXPERIMENTAL

The Sonohystrography will be performed using a Toshiba ECCO CEE SSA-340A ultrasound equipment with a 7.5 MHz transvaginal probe. A sterile vaginal speculum will be inserted, the cervix cleansed with an antiseptic solution, and a thin Foley's catheter inserted into the cervical os. Sterile saline solution will be infused into the uterus through the catheter to distend the uterine cavity. The examiner will use the ultrasound probe to visualize and assess the uterine cavity, focusing on identifying and measuring Cesarean Scar Defects (CSD) characteristics, including depth, width, volume, and myometrial thickness.

Diagnostic Test: Saline-Infused Sonography (Sonohystrography)

Interventions

Three-Dimensional Transvaginal Ultrasound (3D TVS) DIAGNOSTIC_TEST

In this study, Three-Dimensional Transvaginal Ultrasound will be employed as one of the interventions to evaluate Cesarean Scar Defects (CSD) and associated complications in symptomatic patients with a history of cesarean section. Procedure: A specialized ultrasound machine (Samsung WS80A) equipped with a transvaginal 2-11 MHz probe will be used for the Three-Dimensional Transvaginal Ultrasound examination. The examination will be conducted in the 1st half of the menstrual cycle. The ultrasound probe will be introduced into the posterior fornix of the vagina to capture three-dimensional images of the uterus and scar area. The examiner will identify and measure the characteristics of the Cesarean Scar Defects (CSD), including length, depth, width, volume, residual myometrial thickness, adjacent myometrial thickness, and presence of any branches.

Three-Dimensional Transvaginal Ultrasound (3D TVS)

Saline-Infused Sonography (Sonohystrography) DIAGNOSTIC_TEST

The Sonohystrography will be performed using a Toshiba ECCO CEE SSA-340A ultrasound equipment with a 7.5 MHz transvaginal probe. A sterile vaginal speculum will be inserted, the cervix cleansed with an antiseptic solution, and a thin Foley's catheter inserted into the cervical os. Sterile saline solution will be infused into the uterus through the catheter to distend the uterine cavity. The examiner will use the ultrasound probe to visualize and assess the uterine cavity, focusing on identifying and measuring Cesarean Scar Defects (CSD) characteristics, including depth, width, volume, and myometrial thickness.

Saline-Infused Sonography (Sonohystrography)

Eligibility Criteria

• Age: 20 Years - 45 Years
• Gender Eligibility Details: Women aged between 20 and 45 years with a history of 1 to 3 previous cesarean sections (CS) and a duration of time since the last CS ranging from 6 months to 5 years will be eligible for enrollment in this study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 20 and 45 years
• Previous 1-3 cesarean sections
• The duration from the last cesarean section ranging from 6 months to 5 years.

You may not qualify if:

• Pregnancy (Positive pregnancy test)
• Recent pelvic infection.
• Active pelvic infection.
• Recent surgery on the tubes or the uterus.
• Active vaginal bleeding.
• Menstruation.
• Suspected malignancy.
• Intrauterine device in situ.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Metrorrhagia

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Israa Sherif, MBBCH

CONTACT

01020277037; israa.bahaa@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Obstetrics and Gynecology, Nile specialized Hospital, Egypt

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: August 18, 2023
• Study Start: August 30, 2023
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: August 18, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: One you after the end of the study

Locations

EG (1)