NCT02887963

Brief Summary

The purpose of this study is to know the prevalence of iron deficiency (ID) and iron deficiency anemia (IDA) among pregnant women in Chinese urban district at present, and to analyze the epidemiological characteristics of ID/IDA and influencing factors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

March 27, 2017

Status Verified

March 1, 2017

Enrollment Period

2 months

First QC Date

August 29, 2016

Last Update Submit

March 24, 2017

Conditions

Anemia, Iron-Deficiency

Keywords

Iron DeficiencyIron Deficiency AnemiaPregnant WomenGestationChinaEpidemiology

Outcome Measures

Primary Outcomes (2)

  • Iron Deficiency (ID)

    serum ferritin concentration less than 20 μg/L

    two months

  • Iron Deficiency Anemia (IDA)

    serum ferritin concentration less than 20 μg/L and hemoglobin less than 110 g/L

    two months

Secondary Outcomes (1)

  • Use of iron supplements

    two months

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chinese pregnant women receiving outpatient service at selected hospitals

You may qualify if:

  • Receive outpatient service at selected hospitals for the first time during the survey period;
  • Sign an informed consent form;
  • At selected hospitals, establish registry of personal file for obstetric examination, or ensure regular follow-up.

You may not qualify if:

  • Participate in any clinical trial of medicine or nutrition from 3 months before pregnancy till survey time.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese Evidence-based Medicine Centre, West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Anemia, Iron-DeficiencyIron Deficiencies

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chinese Evidence-based Medicine Centre

Study Record Dates

First Submitted

August 29, 2016

First Posted

September 2, 2016

Study Start

September 1, 2016

Primary Completion

November 1, 2016

Study Completion

January 1, 2017

Last Updated

March 27, 2017

Record last verified: 2017-03

Locations

CN(1)