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Trial record 7 of 1660 for:    Recruiting, Not yet recruiting, Available Studies | "Genital Diseases, Female"

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

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ClinicalTrials.gov Identifier: NCT03135353
Recruitment Status : Recruiting
First Posted : May 1, 2017
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Dina Mohamed Refaat Dakhly, Woman's Health University Hospital, Egypt

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

Condition or disease Intervention/treatment Phase
Gynecologic Disease Device: 3D saline infusion sonohysterography Device: Office Hysteroscopy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Comparison Between 3D Saline Infusion Sonohystrography and Office Hysteroscopy in the Evaluation of Patients With Irregular Uterine Bleeding
Actual Study Start Date : April 20, 2017
Estimated Primary Completion Date : November 25, 2018
Estimated Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. effectiveness of SIS versus office hysteroscopy in the diagnosis of cause of AUB [ Time Frame: 6 months ]
    The results of the two procedures would be compared with the operative findings and later histopathological assessment of the specimens



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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03135353


Contacts
Contact: Dina MR Dakhly, MD 01003498919 ext 002 dinadakhly@gmail.com
Contact: Yasmin A Bassiouny, MD 01001720751 ext 002 y_bas@hotmail.com

Locations
Egypt
Kasr el ainy hospital Recruiting
Cairo, Egypt, 12211
Contact: Dina M Dakhly, M.D.    01003498919 ext +2    Dinadakhly@mail.com   
Principal Investigator: Dina M Dakhly, M.D.         
Sponsors and Collaborators
Woman's Health University Hospital, Egypt
Investigators
Principal Investigator: Dina MR Dakhly, MD Cairo University

Responsible Party: Dina Mohamed Refaat Dakhly, Assistant Professor Obstetrics and Gynecology, Woman's Health University Hospital, Egypt
ClinicalTrials.gov Identifier: NCT03135353     History of Changes
Other Study ID Numbers: ED200417
First Posted: May 1, 2017    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Uterine Hemorrhage
Genital Diseases, Female
Uterine Diseases
Hemorrhage
Pathologic Processes