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Completed

NCT Number: NCT02304510

Prevalence of Heavy Menstrual Bleeding in Female Population Living in Beijing

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.

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Key information

Conditions

Menorrhagia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Menstruation Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Peking University Health Science Center

Beijing, 100191, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Prevalence of HMB

    Time frame: from date of inclusion until the end of the study currently planned (about 7 months)

Secondary outcomes

  1. 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.

  2. 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).

Sponsors and collaborators

Lead sponsor

Peking University

Other

Collaborators

  • Bayer

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Dec 2, 2014
Registry last updated
Dec 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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