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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.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04934280
Enrollment
2
Registered
2021-06-22
Start date
2021-06-20
Completion date
2022-02-20
Last updated
2021-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section Niche Evaluation

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.

Interventions

DIAGNOSTIC_TESTsonohysterography

saline infusion transvaginally followed by 2D transvaginal ultrasound imaging

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* women having other gynecological pathology other than niche

Design outcomes

Primary

MeasureTime frameDescription
accurate evaluation of CS section niche6 months from the date of approvalcomparison of imaging CS niche by 2D transvaginal US and sonohysterography

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026