Prevalence of Heavy Menstrual Bleeding in Female Population Living in Beijing

Menorrhagia Clinical Trial

Official title:

Prevalence of Heavy Menstrual Bleeding in Female Population Living in Beijing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02304510
• Other study ID #: PEKU-BJ-2014
• Status: Completed
• Start date: November 2014
• Est. completion date: December 2016

Study information

• Verified date: December 2018
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2455
• Est. completion date: December 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Menorrhagia

Locations

Country	Name	City	State
China	Peking University Health Science Center	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University	Bayer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of HMB		from date of inclusion until the end of the study currently planned (about 7 months)
Secondary	Prevalence of HMB in different subgroups	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)
Secondary	Identify risk factors associated with HMB	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)