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Trial record 15 of 825 for:    Recruiting, Not yet recruiting, Available Studies | Bleeding

A Review on the Outcome of Patient Managed in Postmenopausal Bleeding Clinic

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ClinicalTrials.gov Identifier: NCT03382145
Recruitment Status : Recruiting
First Posted : December 22, 2017
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
CHEUNG CHUN WAI, Chinese University of Hong Kong

Brief Summary:

Postmenopausal bleeding (PMB) is a common gynaecological complaint, accounting for up to 5 to 10 % of postmenopausal women being referred to gynaecological outpatient clinic. It also comprised of up to 10% of our outpatient gynaecological referral. In general, 60 % of women with postmenopausal bleeding have no organic causes identified, whilst benign causes of PMB includes atrophic vaginitis, endometrial polyp, submucosal fibroid and functional endometrium. However, between 5.7 to 11.5% of women with postmenopausal bleeding have endometrial carcinoma, which is the fourth most common cancer among women, therefore, it is important to investigate carefully to exclude genital tract cancer.

A One-stop postmenopausal bleeding clinic has been established since February, 2002 by the Department of Obstetrics and Gynaecology, New Territories East cluster (NTEC) aiming at providing immediate assessment of women with postmenopausal bleeding in one single outpatient clinic assessment. During the visit, a detailed history was taken in regarding the PMB and usage of hormonal replacement therapy or herbal medicine. A physical examination was performed and a cervical smear was taken if not been taken within a year. Transvaginal ultrasound (TVS) was then performed to measure the endometrial thickness (ET), examining ovaries then followed by an endometrial sampling. An outpatient hysteroscopy was performed only if TVS showed an ET >= 5mm, or an abnormal endometrial appearance or unsatisfactory ET. Benign looking endometrial polyp would be removed during the outpatient hysteroscopy if possible.

At the moment, there was very limited local data and lack of the long term result. Investigators aim to retrospectively evaluate the clinical outcome of postmenopausal bleeding patients who has attended One Stop Postmenopausal Clinic in order to formulate better care and counseling in future.

Objectives:

  1. To analyze histopathology in relative to history and ultrasound findings in PMB women presented to One Stop Postmenopausal Bleeding Clinic at NTEC
  2. To correlate the clinical findings of transvaginal ultrasonography (TVS) with outpatient hysteroscopy and endometrial assessment in The One Stop Postmenopausal Bleeding Clinic
  3. To identify predictive and prognostic factors in women with PMB for possible use in triaging high risk patients

Condition or disease Intervention/treatment
Postmenopausal Bleeding Other: No intervention

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 12000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Review on the Outcome of Patient Managed in One Stop Postmenopausal Bleeding Clinic in New Territories East Cluster, NTEC
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Group/Cohort Intervention/treatment
postmenopausal bleeding women
Retrospective review on outcome of One stop Postmenopausal bleeding clinic in New Territorial Eastern Cluster, Hong Kong. Single group study, no intervention.
Other: No intervention
No intervention




Primary Outcome Measures :
  1. To assess any correlation between histolopathology and transvaginal ultrasonography in postmenopausal women at Tertiary centre [ Time Frame: Baseline ]
    To review all Medical records of all patients who presented to our One- Stop clinic at New Territories East Cluster will be reviewed. Patient's demographic data, presenting symptoms, clinical assessments, investigations and treatments will be collected. If they had operations performed, surgical pathology, if any, will also be reviewed.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All women with postmenopausal bleeding presented to One-Stop PMB clinic were enrolled for analysis. Menopause was defined as the cessation of menses for more than 1 year.
Criteria

Inclusion Criteria:

  • Menopausal
  • postmenopausal bleeding

Exclusion Criteria:

  • had less than one year of amenorrhoea
  • amenorrhoea due to medication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03382145


Contacts
Contact: Chun Wai Cheung 852-35052813 evacwcheung@cuhk.edu.hk

Locations
Hong Kong
The Chinese University of Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: Chun Wai Cheung    852-35052813    evacwcheung@cuhk.edu.hk   
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Chun Wai Cheung Chinese University of Hong Kong
  Study Documents (Full-Text)

Documents provided by CHEUNG CHUN WAI, Chinese University of Hong Kong:
Study Protocol  [PDF] October 20, 2017


Responsible Party: CHEUNG CHUN WAI, clinical Honorary Associate Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03382145     History of Changes
Other Study ID Numbers: CRE 2017.475
First Posted: December 22, 2017    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hemorrhage
Uterine Hemorrhage
Pathologic Processes
Uterine Diseases
Genital Diseases, Female