3 Dimensional Ultrasound in Comparison to Hysteroscopy in Myomas

Completed

• Conditions: Fibroid
• Interventions: Diagnostic Test: 3D Ultrasound; Diagnostic Test: Hysteroscopy

• Registration Number: NCT04736095
• Lead Sponsor: Aljazeera Hospital

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2021-01-29
• Study First Submitted QC: 2021-01-29
• Study First Posted: 2021-02-03
• Study Start: 2021-02-07
• Status Verified: 2021-05
• Primary Completion: 2021-05-15
• Study Completion: 2021-05-17
• Last Update Submitted: 2021-05-21
• Last Update Posted: 2021-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
3D ultrasound for diagnosis of submucous myomas	3D Ultrasound	-
Hysteroscopy for diagnosis of submucous myoma	Hysteroscopy	-

Primary Outcome Measures

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

Trial Locations

Locations (2)

Algazeerah; 🇪🇬 Giza, Egypt

Aljazeera( Al Gazeera) hospital; 🇪🇬 Giza, Egypt