Prevalence of Heavy Menstrual Bleeding in Female Populati... | NCT02304510

Studies
Prevalence of Heavy Menstrual Bleeding in Female Population Living in Beijing

NCT02304510

Sponsor

Peking University

Status

Completed

Last Update Posted

Dec 31, 2018Actual

Enrollment

2,455Actual

Phase

Not provided

Conditions

Menorrhagia

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2014Actual

Primary Completion Date

Sep 2015Actual

Completion Date

Dec 2016Actual

First Submitted Date

Nov 27, 2014

First Submission Date that Met QC Criteria

Nov 27, 2014

First Posted Date

Dec 2, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 28, 2018

Last Update Posted Date

Dec 31, 2018Actual

Name	Class
Bayer	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,455Actual

Label	Type	Description	Intervention Names
females		females aged between 18 and 50 years old living in Beijing

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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)
Identify risk factors associated with HMB

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

residents of Beijing

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Siyan Zhan, MD,PhD	Peking University Health Science Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University Health Science Center		Beijing		100191	China

Condition Browse Module

MeSH Terms

ID	Term
D008595	Menorrhagia

Ancestor Terms

ID	Term
D014592	Uterine Hemorrhage
D014591	Uterine Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided