NCT03847415

Brief Summary

The aim of this prospective observational study is to evaluate abnormal uterine bleeding in postmenopausal women using 3D(dimensional) ultrasound assessment of endometrial volume .Doppler assessment of endometrium and hysteroscopy and to correlate this finding with pathological finding of endometrial biopsy

Trial Health

35
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 all trials

Timeline
Completed

Started Feb 2019

Shorter than P25 for all trials

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

Study Start

First participant enrolled

February 1, 2019

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 20, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

February 20, 2019

Status Verified

February 1, 2019

Enrollment Period

7 months

First QC Date

February 9, 2019

Last Update Submit

February 18, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • accuracy of 3d ultrasound in post menopausal bleeding

    to evalute women with postmenpausal uterine bleeding using three dimensional ultrasound assessment of endometrial volume

    6months

Secondary Outcomes (1)

  • comparison between hysteroscopy and ultrasound in post menopausal bleeding

    6months

Interventions

ultrasoundDIAGNOSTIC_TEST

to evalute abnormal uterine bleeding in postmenopausal women using 3D(dimensional) ultrasound assessment of endometrial volume .Doppler assessment of endometrium and hysteroscopy and to correlate this finding with pathological finding of endometrial biopsy

Also known as: hysteroscopy, fractional currettage

Eligibility Criteria

Age45 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women Age \> 45 years postmenopausal uterine bleeding

You may qualify if:

  • Women Age \> 45 years
  • with postmenopausal uterine bleeding

You may not qualify if:

  • Women with bleeding disorders or coagulopathy
  • women with cervical cancer or breast carcinoma .
  • history of tamoxifen intake
  • women with fibroid .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Goldstein SR. Modern evaluation of the endometrium. Obstet Gynecol. 2010 Jul;116(1):168-176. doi: 10.1097/AOG.0b013e3181dfd557.

    PMID: 20567184BACKGROUND
  • Jacobs I, Gentry-Maharaj A, Burnell M, Manchanda R, Singh N, Sharma A, Ryan A, Seif MW, Amso NN, Turner G, Brunell C, Fletcher G, Rangar R, Ford K, Godfrey K, Lopes A, Oram D, Herod J, Williamson K, Scott I, Jenkins H, Mould T, Woolas R, Murdoch J, Dobbs S, Leeson S, Cruickshank D, Skates SJ, Fallowfield L, Parmar M, Campbell S, Menon U. Sensitivity of transvaginal ultrasound screening for endometrial cancer in postmenopausal women: a case-control study within the UKCTOCS cohort. Lancet Oncol. 2011 Jan;12(1):38-48. doi: 10.1016/S1470-2045(10)70268-0. Epub 2010 Dec 10.

    PMID: 21147030BACKGROUND

MeSH Terms

Interventions

UltrasonographyHysteroscopy

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, Obstetrical and GynecologicalEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeObstetric Surgical ProceduresGynecologic Surgical ProceduresUrogenital Surgical Procedures

Central Study Contacts

Mohamed Reda, M.D

CONTACT

Ahmed Aref

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assisant lecturer

Study Record Dates

First Submitted

February 9, 2019

First Posted

February 20, 2019

Study Start

February 1, 2019

Primary Completion

September 1, 2019

Study Completion

October 1, 2019

Last Updated

February 20, 2019

Record last verified: 2019-02