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

Gynecologic Disease Clinical Trial

Official title:

Comparison Between 3D Saline Infusion Sonohystrography and Office Hysteroscopy in the Evaluation of Patients With Irregular Uterine Bleeding

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03135353
• Other study ID #: ED200417
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2017
• Est. completion date: November 30, 2018

Study information

• Verified date: October 2018
• Source: Woman's Health University Hospital, Egypt
• Contact: Dina MR Dakhly, MD
• Phone: 01003498919
• Email: dinadakhly[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: November 30, 2018
• Est. primary completion date: November 25, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Genital Diseases, Female
• Gynecologic Disease
• Uterine Hemorrhage

Intervention

Device:
• 3D saline infusion sonohysterography
instillation of saline in the uterine cavity using pediatric foley's catheter, then performing 3D ultrasound scan of the uterus and adenexae
• Office Hysteroscopy
an outpatient procedure done to assess the uterine cavity using the office hysteroscopy

Locations

Country	Name	City	State
Egypt	Kasr el ainy hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Woman's Health University Hospital, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	effectiveness of SIS versus office hysteroscopy in the diagnosis of cause of AUB	The results of the two procedures would be compared with the operative findings and later histopathological assessment of the specimens	6 months