Epidemiological Study of Iron Deficiency and Iron Deficiency Anemia in Chinese Pregnant Women

NCT ID: NCT02887963

Last Updated: 2017-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-01-31

Brief Summary

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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.

Detailed Description

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This is a national large-scale multi-center cross-sectional survey aimed at investigating the epidemiology of iron deficiency (ID) and iron deficiency anemia (IDA) among Chinese pregnant women in the real world at present, which is anticipated to complete enrollment in two months. A total of 24 hospitals are selected from 6 regions (north, northeast, east, south, southwest, and northwest) of China by the method of multi-stage stratified sampling, each region with one tertiary teaching hospital and three general hospital or health care hospital for women and children. According to the sample size calculation formula combined with the feasibility and flexibility of study, 12000 eligible outpatient pregnant women are expected to be enrolled. Structured questionnaires, which are needed filled in both by patients and doctors, are used to collect participants' data, including basic demographic characteristics (age, occupation, educational level, family income, etc.), reproductive factors (menstrual history, times of pregnancy or parity, history of cesarean section, etc.), pre-pregnancy weight, pregnancy comorbidities and complications, laboratory test of blood routine and serum iron protein, use of iron supplements, diet and living habits during pregnancy, and others. The outcomes are defined by the recommendations on the guidelines for the diagnosis and treatment of Chinese iron deficiency and iron deficiency anemia during gestation period in 2014. All these data are requested to input the electronic data collecting (EDC) system in time and managed level-to-level, with Chinese Evidence-based Medicine Centre finally monitoring the quality of data. During the whole course, no intervention is given to the participants and thus will not have a negative effect on the health and rights of the participants.

Conditions

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Anemia, Iron-Deficiency

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

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

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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West China Second University Hospital

OTHER

Sponsor Role collaborator

Sichuan Provincial Hospital for Women and Children

OTHER

Sponsor Role collaborator

Panzhihua Central Hospital

OTHER

Sponsor Role collaborator

Chongqing Medical Center for Women and Children

OTHER

Sponsor Role collaborator

Obstetrics and Gynecology Hospital of Zhejiang University

UNKNOWN

Sponsor Role collaborator

Xiamen Medical Center for Women and Children

UNKNOWN

Sponsor Role collaborator

Wenzhou People's Hospital

OTHER

Sponsor Role collaborator

Suzhou Municipal Hospital

OTHER

Sponsor Role collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role collaborator

Maternal and Child Health Hospital of Hubei Province

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Guangxi Medical University

OTHER

Sponsor Role collaborator

Shanxi Provincial Maternity and Children's Hospital

OTHER

Sponsor Role collaborator

The Second Affiliated Hospital of Shanxi University of Traditional Chinese Medicine

UNKNOWN

Sponsor Role collaborator

Yan'an University Affiliated Hospital

OTHER

Sponsor Role collaborator

Xinjiang Provincial Hospital for Women and Children

UNKNOWN

Sponsor Role collaborator

Shengjing Hospital

OTHER

Sponsor Role collaborator

Dalian Maternity and Child Care Hospital

OTHER

Sponsor Role collaborator

Changchun Obstetrics and Gynecology Hospital

UNKNOWN

Sponsor Role collaborator

The Fourth Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role collaborator

Beijing Obstetrics and Gynecology Hospital

OTHER

Sponsor Role collaborator

Tianjin Central Hospital of Gynecology Obstetrics

OTHER

Sponsor Role collaborator

The Fourth Hospital of Shijiazhuang

OTHER

Sponsor Role collaborator

Beijing Friendship Hospital

OTHER

Sponsor Role collaborator

West China Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jing Tan

Chinese Evidence-based Medicine Centre

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Chengdu, Sichuan, China

Site Status

Countries

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China

Other Identifiers

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IDA-China-2016

Identifier Type: -

Identifier Source: org_study_id

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