Clinical trial NCT02887963: Epidemiological Study of Iron Deficiency and Iron Deficiency Anemia in Chinese Pregnant Women
Official title: Epidemiological Study of Iron Deficiency and Iron Deficiency Anemia Among Pregnant Women: A National Multicenter Survey in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia, Iron-Deficiency
Keywords: Iron Deficiency
Iron Deficiency Anemia
Pregnant Women
Gestation
China
Epidemiology
Lead sponsor: West China Hospital
Sponsor class: OTHER
Collaborators: name: West China Second University Hospital
name: Sichuan Provincial Hospital for Women and Children
name: Panzhihua Central Hospital
name: Chongqing Medical Center for Women and Children
name: Obstetrics and Gynecology Hospital of Zhejiang University
name: Xiamen Medical Center for Women and Children
name: Wenzhou People's Hospital
name: Suzhou Municipal Hospital
name: Wuhan Union Hospital, China
name: Maternal and Child Health Hospital of Hubei Province
name: The First Affiliated Hospital of Zhengzhou University
name: First Affiliated Hospital of Guangxi Medical University
name: Shanxi Provincial Maternity and Children's Hospital
name: The Second Affiliated Hospital of Shanxi University of Traditional Chinese Medicine
name: Yan'an University Affiliated Hospital
name: Xinjiang Provincial Hospital for Women and Children
name: Shengjing Hospital
name: Dalian Maternity and Child Care Hospital
name: Changchun Obstetrics and Gynecology Hospital
name: The Fourth Affiliated Hospital of Harbin Medical University
name: Beijing Obstetrics and Gynecology Hospital
name: Tianjin Central Hospital of Gynecology Obstetrics
name: Fourth Hospital of Shijiazhuang City
name: Beijing Friendship Hospital
First posted: 2016-09-02
Enrollment: 12000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese pregnant women receiving outpatient service at selected hospitals

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Iron Deficiency (ID)
timeFrame: two months
measure: Iron Deficiency Anemia (IDA)
timeFrame: two months
Secondary outcomes:
measure: Use of iron supplements
timeFrame: two months
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Chinese Evidence-based Medicine Centre, West China Hospital, Sichuan University
state: Sichuan
Study officials:
References: