Diagnostic Yield of Transvaginal Ultrasonography Versus Sonohysterography in Detection of Ceserean Section Niche

Diagnostic Yield of Transvaginal Ultrasonography Versus Sonohysterography in the Evaluation of Ceserean Section Niche.

The aim of this study is to compare the identification of CS scar niche between 2D transvaginal ultrasonography alone and with the use of saline infusion as a contrast. Does it differ in the measurements and identification or not.

Study Overview

• Status: Not yet recruiting
• Conditions: Cesarean Section Niche Evaluation
• Intervention / Treatment: Diagnostic test: sonohysterography

Detailed Description

Cesarean section (CS) rate is increasing in recent practice with a corresponding increase in associated complication. One of these complications is the CS scar defect or 'niche'. A niche forms after CS at the site of hysterotomy of the anterior uterine wall. Recently, it has been demonstrated that niche may be the causative factor for abnormal uterine bleeding, dysmenorrhea, obstetric complications in subsequent pregnancies and possibly subfertility. Therefore, the accurate measurement and description of a niche is becoming increasingly important, for the clinical assessment of gynecological symptoms and for the planning of possible surgical treatment.A niche can be examined using two- (2D) or three- (3D) dimensional transvaginal sonography (TVS), with or without saline or gel contrast, magnetic resonance imaging and hysteroscopy. We will examine about 30 patients of non pregnant women with previous CS having gynecological complications or seeking fertility. All participants will be subjected to 2D vaginal examination to exclude uterine pathology followed by 2D transvaginal ultrasonography with saline infusion using 10-20 ml of sterile Na Cl 0.9% solution injected through the cervix using a 2 mm sterile disposable catheter or IOL Foley catheter. The procedure will be done postmenstrually.

• Study Type: Interventional
• Enrollment (Anticipated): 2
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• women with previous CS section scar seeking pregnancy or having gynecological complications

Exclusion Criteria:

• women having other gynecological pathology other than niche

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 2D transvaginal ultrasonography	Diagnostic test: sonohysterography; saline infusion transvaginally followed by 2D transvaginal ultrasound imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
accurate evaluation of CS section niche	comparison of imaging CS niche by 2D transvaginal US and sonohysterography	6 months from the date of approval

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Anticipated): June 20, 2021
• Primary Completion (Anticipated): December 20, 2021
• Study Completion (Anticipated): February 20, 2022

Study Registration Dates

• First Submitted: June 16, 2021
• First Submitted That Met QC Criteria: June 19, 2021
• First Posted (Actual): June 22, 2021

Study Record Updates

• Last Update Posted (Actual): June 22, 2021
• Last Update Submitted That Met QC Criteria: June 19, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: Soh-Med-21-06-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No