Prevalence of Heavy Menstrual Bleeding in Female Population Living in Beijing

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02304510

Enrollment

2455

Registered

2014-12-02

Start date

2014-11-30

Completion date

2016-12-31

Last updated

2018-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menorrhagia

Keywords

Prevalence, Menorrhagia

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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).

Countries

China

Outcome results