NCT03404154

Brief Summary

The unbalanced estrogen with no progesterone will lead to endometrial thickening .This thickening result in endometrial hyperplasia \& carcinoma and lead to irregular bleeding

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 12, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

January 18, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 19, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2018

Completed
Last Updated

October 2, 2018

Status Verified

October 1, 2018

Enrollment Period

7 months

First QC Date

January 12, 2018

Last Update Submit

October 1, 2018

Conditions

Postmenopausal Bleeding

Outcome Measures

Primary Outcomes (1)

  • the number of participants who where diagnosed by 3D vocal to have endometrial carcinoma

    it describes how many women will be properly diagnosed with carcinoma

    within 4 weeks

Interventions

3D ultrasoundDIAGNOSTIC_TEST

it describes the diagnostic test which is 3D us to diagnose the cause of postmenopausal bleeding

Dilatation and curretagePROCEDURE

it describes the surgical maneuver that will be made to diagnose cause of bleeding

Eligibility Criteria

Age50 Years - 80 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspostmenopausal women with vaginal bleeding
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Postmenopausal women who were Complaining of Post-menopausal vaginal bleeding.

You may qualify if:

  • Postmenopausal women who were Complaining of Post-menopausal vaginal bleeding.

You may not qualify if:

  • Women with hormone replacement therapy.
  • Women showing intra-cavitary fluid collection at ultrasound examination
  • Women with other gynecological lesions in the pelvis other than the uterus
  • Previous diagnosis of endometrial pathology.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Algazeerah

Giza, Egypt

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Dilatation and curettage endometrial biopsy

MeSH Terms

Interventions

Dilatation

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Mahmoud Alalfy

    Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
4 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Researcher , National Research centre and Specialist of Obstetrics and Gynecology in Aljazeerah hospital

Study Record Dates

First Submitted

January 12, 2018

First Posted

January 19, 2018

Study Start

January 18, 2018

Primary Completion

August 1, 2018

Study Completion

August 25, 2018

Last Updated

October 2, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)