Prevalence of Heavy Menstrual Bleeding in Female Population Living in Beijing

Sponsor

Peking University (Other)

Overall Status

Completed

CT.gov ID

NCT02304510

Collaborator

Bayer (Industry)

2,455

Enrollment

Location

Actual Duration (Months)

98.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Menorrhagia

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 Design

Study Type:

Observational

Actual Enrollment :

2455 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Prevalence of Heavy Menstrual Bleeding in Female Population Living in Beijing

Actual Study Start Date :

Nov 1, 2014

Actual Primary Completion Date :

Sep 1, 2015

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
females females aged between 18 and 50 years old living in Beijing

Outcome Measures

Primary Outcome Measures

Prevalence of HMB [from date of inclusion until the end of the study currently planned (about 7 months)]

Secondary Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University Health Science Center	Beijing		China	100191

Sponsors and Collaborators

Peking University
Bayer

Investigators

Principal Investigator: Siyan Zhan, MD,PhD, Peking University Health Science Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Siyan Zhan, Professor, Peking University

ClinicalTrials.gov Identifier:

NCT02304510

Other Study ID Numbers:

PEKU-BJ-2014

First Posted:

Dec 2, 2014

Last Update Posted:

Dec 31, 2018

Last Verified:

Dec 1, 2018

Keywords provided by Siyan Zhan, Professor, Peking University

Prevalence

Menorrhagia

Additional relevant MeSH terms:

Menorrhagia

Study Results

No Results Posted as of Dec 31, 2018