3 Dimensional Ultrasound in Comparison to Hysteroscopy in Myomas

NCT04736095 | Completed DMC

• 1 other identifier: 3D
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

• 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.

Conditions

Fibroid

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

3D ultrasound for diagnosis of submucous myomas

Diagnostic Test: 3D Ultrasound

Hysteroscopy for diagnosis of submucous myoma

Diagnostic Test: Hysteroscopy

Interventions

3D Ultrasound DIAGNOSTIC_TEST

Doing 3D ultrasound for diagnosis of submucous myoma

3D ultrasound for diagnosis of submucous myomas

Hysteroscopy DIAGNOSTIC_TEST

Doing hysteroscopy for diagnosis of submucous myoma

Hysteroscopy for diagnosis of submucous myoma

Eligibility Criteria

• Age: 20 Years - 60 Years
• Gender Eligibility Details: women with submucous myomas
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Women between 20 and 60 years with abnormal uterine bleeding

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aljazeera Hospital: lead
• Cairo University: collaborator

Study Sites (2)

Algazeerah

Giza, Egypt

Location

Aljazeera( Al Gazeera) hospital

Giza, Egypt

Location

MeSH Terms

Conditions

Leiomyoma

Interventions

Hysteroscopy

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Obstetric Surgical Procedures; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Mahmoud Alalfy, PhD

  Algezeera hospitaland National Research Centre ,Egypt

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 3, 2021
• Study Start: February 7, 2021
• Primary Completion: May 15, 2021
• Study Completion: May 17, 2021
• Last Updated: May 25, 2021

Record last verified: 2021-05

Locations

EG (2)