Clinical Trial: Prevalence of Heavy Menstrual Bleeding in Female Population Living in Beijing

Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational

Official Title: Prevalence of Heavy Menstrual Bleeding in Female Population Living in Beijing

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Peking University

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

Original Primary Outcome: prevalence of heavey menstrual bleeding [ Time Frame: from date of inclusion until the end of the study currently planned (about 7 months) ]

Current Secondary Outcome:

  • 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.
  • 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).


Original Secondary Outcome:

  • risk factors associated with heavey menstrual bleeding [ Time Frame: from date of inclusion until the end of the study currently planned (about 7 months) ]
  • women's awareness of heavey menstrual bleeding [ Time Frame: from date of inclusion until the end of the study currently planned (about 7 months) ]


Information By: Peking University

Dates:
Date Received: November 27, 2014
Date Started: November 2014
Date Completion: July 2015
Last Updated: December 2, 2014
Last Verified: December 2014