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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03135353
Enrollment
250
Registered
2017-05-01
Start date
2017-04-20
Completion date
2018-11-30
Last updated
2018-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gynecologic Disease

Brief 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

Interventions

DEVICE3D 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

an outpatient procedure done to assess the uterine cavity using the office hysteroscopy

Sponsors

Woman's Health University Hospital, Egypt
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
effectiveness of SIS versus office hysteroscopy in the diagnosis of cause of AUB6 monthsThe results of the two procedures would be compared with the operative findings and later histopathological assessment of the specimens

Countries

Egypt

Contacts

Primary ContactDina MR Dakhly, MD
dinadakhly@gmail.com01003498919
Backup ContactYasmin A Bassiouny, MD
y_bas@hotmail.com01001720751

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026