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

Primary Purpose

Cesarean Scar Defects, Cesarean Section Complications, Uterine Scar Dehiscence

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Three-Dimensional Transvaginal Ultrasound (3D TVS)
Saline-Infused Sonography (Sonohystrography)
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cesarean Scar Defects

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Ain Shams University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Three-Dimensional Transvaginal Ultrasound (3D TVS)

Saline-Infused Sonography (Sonohystrography)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 3, 2023
Last Updated
August 10, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05996926
Brief Title
Diagnostic Accuracy of Saline Sonohystrography vs. 3D Transvaginal Ultrasound for Cesarean Scar Defect Assessment
Official Title
Diagnostic Correlation Between Saline Infused Sonohystrography and Three Dimensional Transvaginal Ultrasound in the Assessment of Cesarean Section Scar Defect. A Study of a Diagnostic Test Accuracy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 30, 2023 (Anticipated)
Primary Completion Date
August 30, 2024 (Anticipated)
Study Completion Date
August 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Cesarean section (CS) is a frequently performed surgical procedure in obstetric practice. With a significant number of women undergoing this procedure annually, studying its impact on future reproductive capacity has become increasingly important. The prevalence of cesarean deliveries is rising and constitutes about one-third of all births in both the USA and Italy. As the use of cesarean delivery increases, so do the associated complications, including cesarean scar pregnancy, morbidly adherent placenta, and Cesarean section scar dehiscence and rupture. Cesarean scar defects (CSD) are described using various terms (pouch, niche, or isthmocoele) and are characterized by thinning of the myometrium or a uterine scar dehiscence, often appearing as a triangular shape within the endometrial cavity. The exact prevalence of symptomatic Cesarean scar defects varies due to factors like population differences and lack of standardized criteria. Clinical presentations of Cesarean scar defects range from no symptoms to abnormal uterine bleeding, infertility, dyspareunia, and pelvic pain. Women with a history of Cesarean section are considered high-risk during pregnancy and require specialized assessments to ensure scar integrity. Saline-infused sonography (Sonohystrography) is effective for demonstrating caesarean niches, although transvaginal ultrasound (TVS) is more accessible and commonly used. Experts generally agree that a niche should be defined by an indentation at the CS scar site with a depth of at least 2 mm, and it can be classified as simple, simple with one branch, or complex with multiple branches. Additional measurements, such as the distances between the niche and the vesicovaginal fold, are useful for surgical planning. Given the increasing frequency of cesarean deliveries, healthcare providers will encounter related complications more frequently. Cesarean scar defects are common yet often go undiagnosed. Encouraging vaginal birth after cesarean (VBAC) can help reduce cesarean rates and raise questions about future obstetric practices, especially in developing countries.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Scar Defects, Cesarean Section Complications, Uterine Scar Dehiscence, Vaginal Birth After Cesarean, Abnormal Uterine Bleeding

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Non-Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Three-Dimensional Transvaginal Ultrasound (3D TVS)
Arm Type
Experimental
Arm Description
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.
Arm Title
Saline-Infused Sonography (Sonohystrography)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Three-Dimensional Transvaginal Ultrasound (3D TVS)
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Saline-Infused Sonography (Sonohystrography)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Diagnostic Accuracy of Cesarean Scar Defect Assessment Using 3D TVS
Description
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.
Time Frame
Intraoperatively
Title
Diagnostic Accuracy of Cesarean Scar Defect Assessment Using Saline-Infused Sonography
Description
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.
Time Frame
Intraoperatively

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
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.
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Israa Sherif, MBBCH
Phone
01020277037
Ext
+2
Email
israa.bahaa@gmail.com
Facility Information:
Facility Name
Ain Shams University
City
Cairo
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Israa Sherif, M.B.B.CH
Phone
01020277037
Ext
+2
Email
israa.bahaa@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The study protocol will be available upon a reasonable request.
IPD Sharing Time Frame
One you after the end of the study

Learn more about this trial

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

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