Skip to main content
OpenTrials
Completed

NCT Number: NCT02887963

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

Female

Study type

Observational

Primary location

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

Chengdu, Sichuan, 610041, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Iron Deficiency (ID)

    Time frame: two months

    serum ferritin concentration less than 20 μg/L

  2. Iron Deficiency Anemia (IDA)

    Time frame: two months

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

Secondary outcomes

  1. Use of iron supplements

    Time frame: two months

    Iron agent type, dose and duration for preventing or treating ID/IDA

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Collaborators

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

Registry information

Official study title

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

Acronym: EIDACPW

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Sep 2, 2016
Registry last updated
Mar 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.