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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04736095
Other study ID # 3D
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 7, 2021
Est. completion date May 17, 2021

Study information

Verified date May 2021
Source Aljazeera Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date May 17, 2021
Est. primary completion date May 15, 2021
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 60 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
3D Ultrasound
Doing 3D ultrasound for diagnosis of submucous myoma
Hysteroscopy
Doing hysteroscopy for diagnosis of submucous myoma

Locations

Country Name City State
Egypt Algazeerah Giza
Egypt Aljazeera( Al Gazeera) hospital Giza

Sponsors (2)

Lead Sponsor Collaborator
Aljazeera Hospital Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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