- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03841916
Relation Between Body Mass Index and Endometrial Thickness
March 8, 2019 updated by: Aljazeera Hospital
The Relationship Between Transvaginal Ultrasound Endometrial Thickness and Body Mass Index and Pathology in Postmenopausal Bleeding
Postmenopausal Bleeding (PMB) is defined as recurrent attacks of bleeding occurring in women after menopause one year at least after stoppage of cycles [
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Premalignant lesions and malignant lesions most commonly complex hyperplasia with atypia and carcinoma of the endometrium are present in 1/3 of patients evaluated for postmenopausal bleed-ing, and so investigations for cases of postmeno-pausal bleeding are mandatory
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Giza, Egypt
- Recruiting
- Algazeerah and Kasralainy hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
women with postmenopausal bleeding
Description
Inclusion Criteria:
- menopausal women (defined as minimum of 1 year of amenorrhea after the age of 45 years if only the amenorrhea is not related to pregnancy, medication or disease),
Exclusion Criteria:
- Women with chronic diseases as diabetes mellitus, hypertension or hematological disorders, those received hormone replacement therapy, Tamoxifen or anticoagulant therapy and women with adnexal massed detected by TVUS or apparent causes of bleeding from cervix or vagina e.g. ulcer were excluded.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the number of women who will have a relation between endometrial thickness and BMI
Time Frame: within 2 weeks
|
if there is a relation between increased BMI and endometrial thickness
|
within 2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Mahmoud Alalfy, PhD, Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 2, 2018
Primary Completion (Actual)
March 6, 2019
Study Completion (Anticipated)
March 20, 2019
Study Registration Dates
First Submitted
February 12, 2019
First Submitted That Met QC Criteria
February 12, 2019
First Posted (Actual)
February 15, 2019
Study Record Updates
Last Update Posted (Actual)
March 11, 2019
Last Update Submitted That Met QC Criteria
March 8, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Body mass index
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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