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

Anemia, Iron-Deficiency Clinical Trial

— EIDACPW  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02887963
• Other study ID #: IDA-China-2016
• Status: Completed
• Phase: N/A
• First received: August 29, 2016
• Last updated: March 24, 2017
• Start date: September 2016
• Est. completion date: January 2017

Study information

• Verified date: March 2017
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12000
• Est. completion date: January 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Deficiency Diseases

Locations

Country	Name	City	State
China	Chinese Evidence-based Medicine Centre, West China Hospital, Sichuan University	Chengdu	Sichuan

Sponsors (25)

Lead Sponsor

Collaborator

West China Hospital

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Iron Deficiency (ID)	serum ferritin concentration less than 20 µg/L	two months
Primary	Iron Deficiency Anemia (IDA)	serum ferritin concentration less than 20 µg/L and hemoglobin less than 110 g/L	two months
Secondary	Use of iron supplements	Iron agent type, dose and duration for preventing or treating ID/IDA	two months