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

• Sponsor: Sohag University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04934280
• Collaborator: (none)
• Enrollment: 2
• Arm: 1
• Anticipated Duration (Months): 8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cesarean Section Niche Evaluation	Diagnostic Test: sonohysterography	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 2 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Diagnostic Yield of Transvaginal Ultrasonography Versus Sonohysterography in the Evaluation of Ceserean Section Niche.
• Anticipated Study Start Date: Jun 20, 2021
• Anticipated Primary Completion Date: Dec 20, 2021
• Anticipated Study Completion Date: Feb 20, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. accurate evaluation of CS section niche [6 months from the date of approval]

   comparison of imaging CS niche by 2D transvaginal US and sonohysterography

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Radwa Ahmed Elbahy Mohamed, Resident at diagnostic radiology department, Sohag University
• ClinicalTrials.gov Identifier: NCT04934280
• Other Study ID Numbers: Soh-Med-21-06-10
• First Posted: Jun 22, 2021
• Last Update Posted: Jun 22, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jun 22, 2021