Saline Sonohystrography and Office Hysteroscopy in Evaluation of Cases of Abnormal Uterine Bleeding

Woman's Health University Hospital, Egypt

Status: Unknown

Conditions: Gynecologic Disease

Treatments: Device: 3D saline infusion sonohysterography; Device: Office Hysteroscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT03135353

ED200417

Details and patient eligibility

About

comparing the efficacy of the 3D saline infusion sonohysterography to the diagnostic office hysteroscopy in the diagnosis of the cause of abnormal uterine bleeding in females during their reproductive age

Enrollment: 250 estimated patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• female aged between 20 and 45 years
• with no medical disorders
• approving to participate in the study

Exclusion criteria

• vaginal or cervical lesions
• history or suspicion of PID
• IUD users
• bleeding disorders
• on anticoagulant therapy
• irregular use of oral contraceptive pills

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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250 participants in 2 patient groups

3D saline infusion sonohysterography

Experimental group

Description:

participants presenting with abnormal uterine bleeding will undergo 3D saline infusion sonohysterography

Treatment:

Device: 3D saline infusion sonohysterography

Office hysteroscopy

Experimental group

Description:

after undergoing 3D SIS, cases would undergo office hysteroscopy and the investigator would be blinded to the results of SIS

Treatment:

Device: Office Hysteroscopy