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

Primary Purpose

Gynecologic Disease

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
3D saline infusion sonohysterography
Office Hysteroscopy
Sponsored by
Woman's Health University Hospital, Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gynecologic Disease

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleAccepts 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

Sites / Locations

  • Kasr el ainy hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

3D saline infusion sonohysterography

Office hysteroscopy

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 20, 2017
Last Updated
October 21, 2018
Sponsor
Woman's Health University Hospital, Egypt
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1. Study Identification

Unique Protocol Identification Number
NCT03135353
Brief Title
Saline Sonohystrography and Office Hysteroscopy in Evaluation of Cases of Abnormal Uterine Bleeding
Official Title
Comparison Between 3D Saline Infusion Sonohystrography and Office Hysteroscopy in the Evaluation of Patients With Irregular Uterine Bleeding
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 20, 2017 (Actual)
Primary Completion Date
November 25, 2018 (Anticipated)
Study Completion Date
November 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Woman's Health University Hospital, Egypt

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gynecologic Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
3D saline infusion sonohysterography
Arm Type
Experimental
Arm Description
participants presenting with abnormal uterine bleeding will undergo 3D saline infusion sonohysterography
Arm Title
Office hysteroscopy
Arm Type
Experimental
Arm Description
after undergoing 3D SIS, cases would undergo office hysteroscopy and the investigator would be blinded to the results of SIS
Intervention Type
Device
Intervention Name(s)
3D saline infusion sonohysterography
Intervention Description
instillation of saline in the uterine cavity using pediatric foley's catheter, then performing 3D ultrasound scan of the uterus and adenexae
Intervention Type
Device
Intervention Name(s)
Office Hysteroscopy
Intervention Description
an outpatient procedure done to assess the uterine cavity using the office hysteroscopy
Primary Outcome Measure Information:
Title
effectiveness of SIS versus office hysteroscopy in the diagnosis of cause of AUB
Description
The results of the two procedures would be compared with the operative findings and later histopathological assessment of the specimens
Time Frame
6 months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dina MR Dakhly, MD
Phone
01003498919
Ext
002
Email
dinadakhly@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yasmin A Bassiouny, MD
Phone
01001720751
Ext
002
Email
y_bas@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dina MR Dakhly, MD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr el ainy hospital
City
Cairo
ZIP/Postal Code
12211
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dina M Dakhly, M.D.
Phone
01003498919
Ext
+2
Email
Dinadakhly@mail.com
First Name & Middle Initial & Last Name & Degree
Dina M Dakhly, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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