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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cesarean Section Niche Evaluation

Intervention / Treatment
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* Diagnostic Test: sonohysterography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women with previous CS section scar seeking pregnancy or having gynecological complications Exclusion Criteria: women having other gynecological pathology other than niche
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 2D transvaginal ultrasonography<br> | Diagnostic Test: sonohysterography<br>* saline infusion transvaginally followed by 2D transvaginal ultrasound imaging<br>|

What is the study measuring?
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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 |