Prevalence of Heavy Menstrual Bleeding in Female Population Living in Beijing

Completed

• Conditions: Menorrhagia

• Registration Number: NCT02304510
• Lead Sponsor: Peking University

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 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 Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-27
• Study First Submitted QC: 2014-11-27
• Study First Posted: 2014-12-02
• Primary Completion: 2015-09
• Study Completion: 2016-12
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-28
• Last Update Posted: 2018-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2455

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of HMB	from date of inclusion until the end of the study currently planned (about 7 months)

Secondary Outcome Measures

Name	Time	Method
Prevalence of HMB in different subgroups	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	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).

Trial Locations

Locations (1)

Peking University Health Science Center; 🇨🇳 Beijing, China