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

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

Study Overview

• Status: Unknown
• Conditions: Gynecologic Disease
• Intervention / Treatment: Device: 3D saline infusion sonohysterography; Device: Office Hysteroscopy

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yasmin A Bassiouny, MD; Phone Number: 002 01001720751; Email: y_bas@hotmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 12211
    • Recruiting
    • Kasr el ainy hospital
    • Contact: Dina M Dakhly, M.D.; Phone Number: +2 01003498919; Email: Dinadakhly@mail.com
    • Principal Investigator: Dina M Dakhly, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 3D saline infusion sonohysterography; participants presenting with abnormal uterine bleeding will undergo 3D saline infusion sonohysterography	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
EXPERIMENTAL: Office hysteroscopy; after undergoing 3D SIS, cases would undergo office hysteroscopy and the investigator would be blinded to the results of SIS	Device: Office Hysteroscopy; an outpatient procedure done to assess the uterine cavity using the office hysteroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Woman's Health University Hospital, Egypt

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 20, 2017
• Primary Completion (ANTICIPATED): November 25, 2018
• Study Completion (ANTICIPATED): November 30, 2018

Study Registration Dates

• First Submitted: April 20, 2017
• First Submitted That Met QC Criteria: April 25, 2017
• First Posted (ACTUAL): May 1, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 23, 2018
• Last Update Submitted That Met QC Criteria: October 21, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Uterine Diseases; Hemorrhage; Uterine Hemorrhage
• Other Study ID Numbers: ED200417

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No