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Completed

NCT Number: NCT04736095

3 Dimensional Ultrasound in Comparison to Hysteroscopy in Myomas

• 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.

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Key information

Conditions

Fibroid Leiomyoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue

Age range

20 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

Algazeerah, Giza, Egypt

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3D ultrasound

Diagnostic Test

Doing 3D ultrasound for diagnosis of submucous myoma

Hysteroscopy

Diagnostic Test

Doing hysteroscopy for diagnosis of submucous myoma

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Aljazeera Hospital

Other

Collaborators

  • Cairo University

Registry information

Official study title

3 Dimensional Ultrasound in Comparison to Hysteroscopy in Diagnosis of Myomas

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 3, 2021
Registry last updated
May 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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