3 Dimensional Ultrasound in Comparison to Hysteroscopy in Myomas

NCT ID: NCT04736095

Last Updated: 2021-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-07

Study Completion Date

2021-05-17

Brief Summary

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• 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

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

Conditions

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Fibroid

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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3D ultrasound for diagnosis of submucous myomas

3D Ultrasound

Intervention Type DIAGNOSTIC_TEST

Doing 3D ultrasound for diagnosis of submucous myoma

Hysteroscopy for diagnosis of submucous myoma

Hysteroscopy

Intervention Type DIAGNOSTIC_TEST

Doing hysteroscopy for diagnosis of submucous myoma

Interventions

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3D Ultrasound

Doing 3D ultrasound for diagnosis of submucous myoma

Intervention Type DIAGNOSTIC_TEST

Hysteroscopy

Doing hysteroscopy for diagnosis of submucous myoma

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role collaborator

Aljazeera Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mahmoud Alalfy, PhD

Role: STUDY_CHAIR

Algezeera hospitaland National Research Centre ,Egypt

Locations

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Algazeerah

Giza, , Egypt

Site Status

Aljazeera( Al Gazeera) hospital

Giza, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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3D

Identifier Type: -

Identifier Source: org_study_id

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