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

Not Applicable

• Conditions: Cesarean Section Niche Evaluation
• Interventions: Diagnostic Test: sonohysterography

• Registration Number: NCT04934280
• Lead Sponsor: Sohag University

Brief Summary

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.

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 Timeline

• Status Verified: 2021-06
• Study First Submitted: 2021-06-16
• Study First Submitted QC: 2021-06-19
• Last Update Submitted: 2021-06-19
• Study Start: 2021-06-20
• Study First Posted: 2021-06-22
• Last Update Posted: 2021-06-22
• Primary Completion: 2021-12-20
• Study Completion: 2022-02-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 2

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2D transvaginal ultrasonography	sonohysterography	-

Primary Outcome Measures

Name	Time	Method
accurate evaluation of CS section niche	6 months from the date of approval	comparison of imaging CS niche by 2D transvaginal US and sonohysterography