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

NCT ID: NCT04934280

Last Updated: 2021-06-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-20
• Study Completion Date: 2022-02-20

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.

Conditions

Cesarean Section Niche Evaluation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

2D transvaginal ultrasonography

Group Type: OTHER

sonohysterography

Intervention Type: DIAGNOSTIC_TEST

saline infusion transvaginally followed by 2D transvaginal ultrasound imaging

Interventions

sonohysterography

saline infusion transvaginally followed by 2D transvaginal ultrasound imaging

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• women having other gynecological pathology other than niche

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Radwa Ahmed Elbahy Mohamed

Resident at diagnostic radiology department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Soh-Med-21-06-10

Identifier Type: -

Identifier Source: org_study_id