NCT03382145

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17,956

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 22, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2025

Completed
Last Updated

November 28, 2025

Status Verified

November 1, 2025

Enrollment Period

7.5 years

First QC Date

December 1, 2017

Last Update Submit

November 25, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • To assess any correlation between histolopathology and transvaginal ultrasonography in postmenopausal women at Tertiary centre

    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.

    Baseline

Study Arms (1)

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

Interventions

No intervention

postmenopausal bleeding women

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Menopausal
  • postmenopausal bleeding

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

Study Officials

  • Chun Wai Cheung

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical Honorary Associate Professor

Study Record Dates

First Submitted

December 1, 2017

First Posted

December 22, 2017

Study Start

February 1, 2018

Primary Completion

July 30, 2025

Study Completion

July 30, 2025

Last Updated

November 28, 2025

Record last verified: 2025-11

Locations