Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001137381
Ethics application status
Approved
Date submitted
10/11/2016
Date registered
3/08/2017
Date last updated
11/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Asymptomatic Increased endometrial thickness in postmenopausal women .risk factors
Scientific title
Asymptomatic increased endometrial thickness in postmenopausal women: risk factors
Secondary ID [1] 290510 0
None
Universal Trial Number (UTN)
U1111-1189-6844
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
risk factors causing increased endometrial thickness in post menopause 300911 0
Condition category
Condition code
Reproductive Health and Childbirth 300912 300912 0 0
Menstruation and menopause

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study is evaluating the hypothesis that, there are some factors causing increased the endometrium thickness in some asymptomatic postmenopausal women that carried increased risk of cellular changes. Histopathology will be done for cases with increased thickness.40 minutes consultation at baseline visit .
Intervention code [1] 296364 0
Early Detection / Screening
Comparator / control treatment
73 women in each group of asymptomatic post-menopause women will be recruited ,Women will be divided according to endometrial thickness into:
Group (A): those having 5 mm endometrial thickness or more .
Group (B): those having less than 5 mm endometrial thickness .
Control group
Active

Outcomes
Primary outcome [1] 300135 0
The variation in ET measured by trans-vaginal ultrasound
Timepoint [1] 300135 0
they will be checked at once at baseline visit.
Secondary outcome [1] 334634 0
The variation in ET with respect to presence of myoma by using trans-vaginal ultrasound .
Timepoint [1] 334634 0
once at baseline
Secondary outcome [2] 336416 0
The variation in ET with respect to uterine volume by using trans-vaginal ultrasound .
Timepoint [2] 336416 0
once at baseline

Eligibility
Key inclusion criteria
Postmenopausal women.
No vaginal bleeding.
Intact uterus.
Minimum age
45 Years
Maximum age
60 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women with gynecological symptoms e.g. vaginal bleeding, bloody discharge
Women underwent gynecological operation e.g. hysterectomy or recent D&C.
Women with ovarian or endometrium or cervical cancer.
Patients under hormonal therapy

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
(73 in each arm, asymptomatic post-menopause women will be recruited according to G.Power 3.0.10 software sample size calculator assuming that Effect size d =0.5, a err prob= 0.05, Power (1-Beta err prob) =0.85, Allocation ratio N2/N1 =1

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/10/2017
Actual
14/12/2017
Date of last participant enrolment
Anticipated
Actual
10/04/2018
Date of last data collection
Anticipated
31/10/2018
Actual
14/04/2018
Sample size
Target
146
Accrual to date
Final
146
Recruitment outside Australia
Country [1] 8382 0
Egypt
State/province [1] 8382 0
Cairo

Funding & Sponsors
Funding source category [1] 294924 0
Hospital
Name [1] 294924 0
alzahraa university hospital
Country [1] 294924 0
Egypt
Primary sponsor type
Individual
Name
nahed allam
Address
AlAzhar unversity hospital for girls
4 Dawood Barakat street ,Nasr city
Cairo
Egypt
Country
Egypt
Secondary sponsor category [1] 295354 0
Individual
Name [1] 295354 0
Taaiseer Maarouf
Address [1] 295354 0
Alzhraa university hospital
Elmostashfa elyuonany street,Abassia,cairo
postcode 11651
Country [1] 295354 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296300 0
Ethical committee of the Department of gynecology and obstetrics, Faculty of Medicine, AL-Azhar University
Ethics committee address [1] 296300 0
Ethics committee country [1] 296300 0
Egypt
Date submitted for ethics approval [1] 296300 0
08/05/2016
Approval date [1] 296300 0
03/07/2016
Ethics approval number [1] 296300 0
7833014

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70362 0
Dr Nahed Ezzat Allam
Address 70362 0
AlAzhar university hospital for girls
4 Dawood Barakat sreet,nasr city,cairo
Country 70362 0
Egypt
Phone 70362 0
+201229121089
Fax 70362 0
Email 70362 0
[email protected]
Contact person for public queries
Name 70363 0
Nahed Ezzat Allam
Address 70363 0
Alzahraa university hospital
5 Alyonani hospital street
Abasia ,Cairo
Egypt
Country 70363 0
Egypt
Phone 70363 0
+201229121089
Fax 70363 0
Email 70363 0
[email protected]
Contact person for scientific queries
Name 70364 0
Taiseer Maarouf
Address 70364 0
Alzahraa university hospital
5 Alyonani hospital street
Abasia ,Cairo
Egypt
Country 70364 0
Egypt
Phone 70364 0
+201229121089
Fax 70364 0
Email 70364 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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