3 Dimensional Ultrasound in Comparison to Hysteroscopy in Myomas

3 Dimensional Ultrasound in Comparison to Hysteroscopy in Diagnosis of Myomas

• three-dimensional saline infusion sonohysterography (3D SIS) was performed in all cases. A sterile Cuscoe speculum was passed, the cervix visualized and cleaned with sterile chlorhexidine solution. A 3.3 mm soft plastic paediatric naso-gastric suction catheter was then passed through the cervix into the uterine cavity without grasping the cervix.

Study Overview

• Status: Completed
• Conditions: Fibroid
• Intervention / Treatment: Diagnostic test: 3D Ultrasound; Diagnostic test: Hysteroscopy

Detailed Description

The speculum was removed and a 5 MHz transvaginal 3D ultrasound probe inserted into the vagina (Voluson 730; KretzTechnik, Austria).

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • Algazeerah
  • Giza, Egypt
    • Aljazeera( Al Gazeera) hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Women between 20 and 60 years with abnormal uterine bleeding

Description

Inclusion Criteria:

• • Women between 20 and 60 years with abnormal uterine bleeding in form of heavy menstrual bleeding, irregular and heavy menstrual bleeding) diagnosed on non-enhanced two-dimensional ultrasonography with submucous fibroids.

  • Absence of STD, PID, active vaginal bleeding.

Exclusion Criteria:

• Presence of general cause of abnormal uterine bleeding

  • History of drug use that can cause vaginal bleeding (anticoagulants, OCPs, HRT)
  • History of recent hormonal treatment
  • High risk of undergoing hysteroscopy
  • Vaginal, Vulval causes of bleeding

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
3D ultrasound for diagnosis of submucous myomas	Diagnostic test: 3D Ultrasound; Doing 3D ultrasound for diagnosis of submucous myoma
Hysteroscopy for diagnosis of submucous myoma	Diagnostic test: Hysteroscopy; Doing hysteroscopy for diagnosis of submucous myoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The accuracy of 3D ultrasound in doiagnosis of submucous myomas in comparison to hysteroscopy	How many women will be diagnosed by 3D US to have submucous myoma	one week

Collaborators and Investigators

• Sponsor: Aljazeera Hospital
• Collaborators: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2021
• Primary Completion (Actual): May 15, 2021
• Study Completion (Actual): May 17, 2021

Study Registration Dates

• First Submitted: January 29, 2021
• First Submitted That Met QC Criteria: January 29, 2021
• First Posted (Actual): February 3, 2021

Study Record Updates

• Last Update Posted (Actual): May 25, 2021
• Last Update Submitted That Met QC Criteria: May 21, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Muscle Tissue; Leiomyoma
• Other Study ID Numbers: 3D

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No