CClinicalTrials.gg
CompletedNCT03404154Updated Oct 2, 2018

Vocal in Assessment of Endometrium in Postmenopause

An observational study in Postmenopausal Bleeding, sponsored by Aljazeera Hospital. Completed at 1 site in Egypt. Open to female participants aged 50 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-02.

Sponsored by Aljazeera Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
50 Years to 80 Years
Sex
Female
01

Study summary

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

Read the detailed description

Recent advances in the screening and diagnosis of endometrial pathologies (eg,endometrial hyperplasia , endometrial carcinoma ,endometrial polyps and myomas ) are directed towards non invasive methods as Transvaginal ultrasound with 3 D application using different softwares .

One of the applications of 3D Transvaginal Ultrasonography is Vocal technique ( Virtual Organ Computer aided Analysis ) that can measure volume especially in tissues with irregular borders And this technology is considered to be superior than the conventional 2 D ultrasound . .

02

Conditions studied

  • Postmenopausal Bleeding
03

Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (actual)
Target follow-up
4 Weeks
Patient registry
Yes
Biospecimen retention
Samples without dna

Interventions

  • Diagnostic test3D ultrasound

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

  • ProcedureDilatation and curretage

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

05

What researchers measure

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

    Time frame: within 4 weeks

06

Study locations

1 site
  • Algazeerah
    Giza, Egypt
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03404154
Lead sponsor
Aljazeera Hospital
Collaborators
Kasr El Aini Hospital, om almasreen hospital ,Egypt, National Research Centre, Egypt
Responsible party
Mahmoud Alalfy (Assistant Researcher , National Research centre and Specialist of Obstetrics and Gynecology in Aljazeerah hospital, Aljazeera Hospital) — Principal investigator
First posted
Jan 19, 2018
Start date
Jan 18, 2018
Primary completion
Aug 1, 2018
Completion
Aug 25, 2018
Last update
Oct 2, 2018

Study contacts

Mahmoud Alalfy
principal investigator · Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion