NCT03543592

Brief Summary

100 women suffering post-menopausal bleeding will be included in the study. All the participants will undergo 3D Transvaginal Ultrasound to assess the endometrium and myometrium (for the presence of any focal lesions e.g. polypi) followed by 3D Power Doppler ultrasound assessment of the vascular indices: vascularization index (VI), flow index (FI) and vascularization-flow index (VFI) and endometrial volumes. The results of the ultrasound and Doppler indices will be correlated to the histopathological examination of specimens collected following fractional curettage or hysterectomy.

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 1, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2020

Completed
Last Updated

May 19, 2020

Status Verified

January 1, 2020

Enrollment Period

2.1 years

First QC Date

May 8, 2018

Last Update Submit

May 16, 2020

Conditions

Postmenopausal Bleeding

Keywords

postmenopausal bleedingultrasoundpower dopplerendometrium

Outcome Measures

Primary Outcomes (1)

  • the diagnostic performance of Vascularization index in detecting endometrial carcinoma

    Vascularization index (VI) will be correlated to pathology report

    within 24 hours before the surgical procedure

Secondary Outcomes (3)

  • the diagnostic performance of the endometrial volumes acquired by Three-Dimensional Ultrasound

    within 24 hours before the surgical procedure

  • the diagnostic performance of flow index (FI) in detecting endometrial carcinoma.

    within 24 hours before the surgical procedure

  • the diagnostic performance of vascularization-flow index (VFI) in detecting endometrial carcinoma.

    within 24 hours before the surgical procedure

Study Arms (1)

3 dimensional power Doppler

OTHER

100 women suffering post-menopausal bleeding (occurred after at least 12 months of amenorrhea) will be included in the study and 3 dimensional ultrasonography and Doppler will be done for them

Diagnostic Test: 3 dimensional ultrasonography and Doppler

Interventions

3 dimensional ultrasonography and DopplerDIAGNOSTIC_TEST

Three-Dimensional images will be recorded. The volumes will be generated by the automatic rotation of the mechanical transducer 360 degrees. Visualization of the endometrium and myometrium in the three planes will be done to detect endometrial cavity and any lesions. The power Doppler gate will be activated for blood flow mapping of the endometrium and endometrial-myometrial interface (sub-endometrial area). The pulsed Doppler sample volume will be activated to obtain a flow velocity waveform (FVW). Vascularization index (VI), flow index (FI) and vascularization-flow index (VFI) will be automatically calculated from three consecutive FVWs.

3 dimensional power Doppler

Eligibility Criteria

Age50 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Post-menopausal bleeding (occurred after at least 12 months of amenorrhea)

You may not qualify if:

  • History of hormone administration in the last 6 months.
  • Systemic diseases causing abnormal uterine bleeding as hematologic diseases and chronic medical diseases.
  • Women who experienced artificial or induced menopause because of the use of tamoxifen or any type of hormone replacement therapy.
  • Patients who take any anticoagulant drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

kasr elaini hospital (Cairo university)

Cairo, 115431, Egypt

RECRUITING

MeSH Terms

Interventions

Echocardiography, Doppler

Intervention Hierarchy (Ancestors)

EchocardiographyCardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyUltrasonography, DopplerHeart Function TestsDiagnostic Techniques, Cardiovascular

Central Study Contacts

moutaz elsherbini, MD

CONTACT

+2 01001588300mizosherbini@yahoo.com

Sally El-Attar, MSc

CONTACT

dr_sally_elattar@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

May 8, 2018

First Posted

June 1, 2018

Study Start

June 1, 2018

Primary Completion

July 1, 2020

Study Completion

August 15, 2020

Last Updated

May 19, 2020

Record last verified: 2020-01

Locations

EG(1)