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临床试验/NCT02887963
NCT02887963已完成不适用

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

West China Hospital1 个研究点 分布在 1 个国家目标入组 12,000 人开始时间: 2016年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12,000
试验地点
1
主要终点
Iron Deficiency Anemia (IDA)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Iron Deficiency Anemia (IDA)

时间窗: two months

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

Iron Deficiency (ID)

时间窗: two months

serum ferritin concentration less than 20 μg/L

次要结局

  • Use of iron supplements(two months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jing Tan

Chinese Evidence-based Medicine Centre

West China Hospital

研究点 (1)

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