NCT03135353

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

April 20, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 1, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2018

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

October 23, 2018

Status Verified

October 1, 2018

Enrollment Period

1.6 years

First QC Date

April 20, 2017

Last Update Submit

October 21, 2018

Conditions

Gynecologic Disease

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

3D saline infusion sonohysterography

EXPERIMENTAL

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

Device: 3D saline infusion sonohysterography

Office hysteroscopy

EXPERIMENTAL

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

Device: Office Hysteroscopy

Interventions

3D saline infusion sonohysterographyDEVICE

instillation of saline in the uterine cavity using pediatric foley's catheter, then performing 3D ultrasound scan of the uterus and adenexae

3D saline infusion sonohysterography
Office HysteroscopyDEVICE

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

Office hysteroscopy

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • female aged between 20 and 45 years
  • with no medical disorders
  • approving to participate in the study

You may not qualify if:

  • vaginal or cervical lesions
  • history or suspicion of PID
  • IUD users
  • bleeding disorders
  • on anticoagulant therapy
  • irregular use of oral contraceptive pills

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr el ainy hospital

Cairo, 12211, Egypt

RECRUITING

MeSH Terms

Conditions

Genital Diseases, Female

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Dina MR Dakhly, MD

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dina MR Dakhly, MD

CONTACT

01003498919dinadakhly@gmail.com

Yasmin A Bassiouny, MD

CONTACT

01001720751y_bas@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Obstetrics and Gynecology

Study Record Dates

First Submitted

April 20, 2017

First Posted

May 1, 2017

Study Start

April 20, 2017

Primary Completion

November 25, 2018

Study Completion

November 30, 2018

Last Updated

October 23, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)