Epidemiological Study of Iron Deficiency and Iron Deficiency Anemia in Chinese Pregnant Women (EIDACPW)

Epidemiological Study of Iron Deficiency and Iron Deficiency Anemia Among Pregnant Women: A National Multicenter Survey in China

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.

Study Overview

• Status: Completed
• Conditions: Anemia, Iron-Deficiency

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 12000

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Chinese Evidence-based Medicine Centre, West China Hospital, Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Chinese pregnant women receiving outpatient service at selected hospitals

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Use of iron supplements	Iron agent type, dose and duration for preventing or treating ID/IDA	two months

Collaborators and Investigators

• Sponsor: West China Hospital
• Collaborators: Beijing Friendship Hospital; Obstetrics and Gynecology Hospital of Zhejiang University; Shengjing Hospital; The First Affiliated Hospital of Zhengzhou University; Wuhan Union Hospital, China; West China Second University Hospital; Fourth Hospital of Shijiazhuang City; Maternal and Child Health Hospital of Hubei Province; Suzhou Municipal Hospital; Tianjin Central Hospital of Gynecology Obstetrics; Beijing Obstetrics and Gynecology Hospital; First Affiliated Hospital of Guangxi Medical University; Shanxi Provincial Maternity and Children's Hospital; Yan'an University Affiliated Hospital; Sichuan Provincial Hospital for Women and Children; Panzhihua Central Hospital; Chongqing Medical Center for Women and Children; Xiamen Medical Center for Women and Children; Wenzhou People's Hospital; The Second Affiliated Hospital of Shanxi University of Traditional Chinese Medicine; Xinjiang Provincial Hospital for Women and Children; Dalian Maternity and Child Care Hospital; Changchun Obstetrics and Gynecology Hospital; The Fourth Affiliated Hospital of Harbin Medical University

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: August 29, 2016
• First Submitted That Met QC Criteria: August 29, 2016
• First Posted (Estimate): September 2, 2016

Study Record Updates

• Last Update Posted (Actual): March 27, 2017
• Last Update Submitted That Met QC Criteria: March 24, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: China; Epidemiology; Iron Deficiency Anemia; Iron Deficiency; Pregnant Women; Gestation
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Iron Metabolism Disorders; Anemia, Iron-Deficiency; Anemia
• Other Study ID Numbers: IDA-China-2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided