Prevalence of Heavy Menstrual Bleeding in Female Population Living in Beijing

December 28, 2018 updated by: Siyan Zhan, Peking University
The purpose of the study is to estimate the prevalence of heavy menstrual bleeding (HMB) in females aged between 18 and 50 years old living in Bejing.

Study Overview

Status

Completed

Conditions

Detailed Description

This study is an observational, cross-sectional study. A representative sample of 2800 eligible women with different occupations such as farmers, service providers, workers, professional specialists, students and civil servants will be recruited. A cluster sampling method with probability proportional to the distribution of occupation in women in Beijing will be used. Demographic data will be collected by questionnaire. Menstrual bleeding will be evaluated by Pictorial Blood loss Assessment Chart (PBAC). According to the international definition of HMB, a PBAC score more than 100 is considered as HMB.

Study Type

Observational

Enrollment (Actual)

2455

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

  • China
      • Beijing, China, 100191
        • Peking University Health Science Center

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

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

residents of Beijing

Description

Inclusion Criteria:

  • Females aged between 18 and 50 years (inclusive)
  • Stay in Beijing for more than 6 months
  • Signed ICF was obtained

Exclusion Criteria:

  • Not achieve the menarche
  • With the last menstruation more than one year ago
  • Experienced amenorrhea, currently take hormone therapy to induce menstruation
  • Had undergone a hysterectomy
  • Currently breastfeeding a baby
  • Being pregnant

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

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
females
females aged between 18 and 50 years old living in Beijing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of HMB
Time Frame: from date of inclusion until the end of the study currently planned (about 7 months)
from date of inclusion until the end of the study currently planned (about 7 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of HMB in different subgroups
Time Frame: from date of inclusion until the end of the study currently planned (about 7 months)
Subgroups include groups with different age, occupations, education levels, fertility status, with/without combined gynecological diseases.
from date of inclusion until the end of the study currently planned (about 7 months)
Identify risk factors associated with HMB
Time Frame: from date of inclusion until the end of the study currently planned (about 7 months)
Identified HMB subjects will be assigned into the case group. Non-HMB subjects will be assigned into the control group. Logistic regression model will be carried out to analyze the associations between possible demographic factors and risk of HMB by calculating odds ratios (OR) with 95% confidence intervals (CIs).
from date of inclusion until the end of the study currently planned (about 7 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University

Collaborators

Bayer

Investigators

  • Principal Investigator: Siyan Zhan, MD,PhD, Peking University Health Science Center

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)

November 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

November 27, 2014

First Submitted That Met QC Criteria

November 27, 2014

First Posted (Estimate)

December 2, 2014

Study Record Updates

Last Update Posted (Actual)

December 31, 2018

Last Update Submitted That Met QC Criteria

December 28, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEKU-BJ-2014

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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