Postmenopausal BleedingNCT03841916
Relation Between Body Mass Index and Endometrial Thickness
An observational study of Postmenopausal Bleeding, run by Aljazeera Hospital at 1 site in Egypt.
Trial summary
Postmenopausal Bleeding (PMB) is defined as recurrent attacks of bleeding occurring in women after menopause one year at least after stoppage of cycles [ Read more about this study
- Who is it for?
- Ages 45 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Bleeding
- What is being tested?
- transvaginal ultrasound
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Dec 2018to 20 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: women with postmenopausal bleeding
Who may be able to join
- 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),
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Algazeerah and Kasralainy hospital
Giza
Mahmoud Alalfy, master, +201002611058, mahmoudalalfy@ymail.com
Ahmed Elgazzar, M.D, +201014005959
About this study
Official title: 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 [
Read the 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
- Conditions
- Postmenopausal Bleeding
- Being tested
- transvaginal ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transvaginal ultrasoundDiagnostic test
transvaginal ultrasound to measure endometrial thickness
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of women who will have a relation between endometrial thickness and BMI
if there is a relation between increased BMI and endometrial thickness
Measured: within 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start2 Dec 2018
- Primary completion6 Mar 2019
- Study completion20 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aljazeera Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kasr El Aini Hospital
- Responsible party
- Sponsor
- Investigators
- Mahmoud Alalfy, PhD, Principal investigator, Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03841916
- Sponsor's protocol ID
- Body mass index
- Status last verified
- Mar 2019
- First submitted
- 12 Feb 2019
- Last updated
- 11 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Transvaginal Ultrasound Endometrial Thickness and Body Mass Index and Pathology in Postmenopausal Bleeding
- ClinicalTrials.gov ID
- NCT03841916
- Acronym / sponsor ID
- Body mass index
- Conditions
- Postmenopausal Bleeding
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Aljazeera HospitalUniversity, hospital or other
- Collaborators
- Kasr El Aini Hospital
- Study start
- 2 Dec 2018 (actual)
- Primary completion
- 6 Mar 2019 (actual)
- Study completion
- 20 Mar 2019 (estimated)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postmenopausal Bleeding (PMB) is defined as recurrent attacks of bleeding occurring in women after menopause one year at least after stoppage of cycles [
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- women with postmenopausal bleeding
Key inclusion criteria (1 listed)
- 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),
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transvaginal ultrasoundtransvaginal ultrasound to measure endometrial thickness | Diagnostic test | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2019.
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Non-Invasive Identification of Endometrial Cancer/Endometrial Atypical Hyperplasia With an AI-Based Classifier Applied to Transvaginal Ultrasound in Patients With Post-Menopausal Bleeding
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud Alalfy, PhD principal investigator
Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postmenopausal Bleeding, run by Aljazeera Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Alalfy, PhD (01002611058, mahmoudalalfy@ymail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of women who will have a relation between endometrial thickness and BMI (time frame: within 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2019.