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3 Dimensional Ultrasound in Comparison to Hysteroscopy in Myomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04736095
Recruitment Status : Completed
First Posted : February 3, 2021
Last Update Posted : May 25, 2021
Sponsor:
Collaborator:
Cairo University
Information provided by (Responsible Party):
Aljazeera Hospital

Study Description
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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.

Condition or disease Intervention/treatment
Fibroid 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 Design
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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: 3 Dimensional Ultrasound in Comparison to Hysteroscopy in Diagnosis of Myomas
Actual Study Start Date : February 7, 2021
Actual Primary Completion Date : May 15, 2021
Actual Study Completion Date : May 17, 2021
Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. The accuracy of 3D ultrasound in doiagnosis of submucous myomas in comparison to hysteroscopy [ Time Frame: one week ]
    How many women will be diagnosed by 3D US to have submucous myoma


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   women with submucous myomas
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Women between 20 and 60 years with abnormal uterine bleeding
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04736095


Locations
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Egypt
Algazeerah
Giza, Egypt
Aljazeera( Al Gazeera) hospital
Giza, Egypt
Sponsors and Collaborators
Aljazeera Hospital
Cairo University
Investigators
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Study Chair: Mahmoud Alalfy, PhD Algezeera hospitaland National Research Centre ,Egypt
More Information
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Responsible Party: Aljazeera Hospital
ClinicalTrials.gov Identifier: NCT04736095    
Other Study ID Numbers: 3D
First Posted: February 3, 2021    Key Record Dates
Last Update Posted: May 25, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leiomyoma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms