Clinical trial NCT03961074: Iron Deficiency Anemia Among Chinese Pregnant Women: a Multi-center Prospective Cohort Study
Official title: Iron Deficiency Anemia Among Chinese Pregnant Women (IRON WOMEN): a Multi-center Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Iron Deficiency Anemia of Pregnancy
Keywords: Iron Deficiency Anemia
iron supplements
Chinese pregnant women
adverse maternal outcomes
adverse neonatal outcome
Lead sponsor: West China Hospital
Sponsor class: OTHER
Collaborators: name: West China Second University Hospital
First posted: 2019-05-23
Enrollment: 5551
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chinese pregnant women who established a health record at one of the survey hospital in seven cities of China.

Brief summary: Iron deficiency anemia during pregnancy, which may lead to adverse pregnancy outcomes, was a serious health problem in China. Various iron supplements used in different regions of China, however, the effects have not been well investigated. The objective of this study is to investigate the diagnosis, treatment and prognosis of iron deficiency and iron deficiency anemia in Chinese pregnant women.

Detailed description: This is a nationwide multicenter prospective cohort study conducted in seven hospitals in China to investigate the diagnosis, treatment and prognosis of iron deficiency and iron deficiency anemia in Chinese pregnant women. This study will enroll about 6000-7000 pregnant women, who established a health record in the seven hospitals. Demographic characteristics, laboratory tests, behavior habits during pregnancy, mental status, and pregnancy outcomes will been collected. All information will collect by a pregnant women self-reported questionnaire and the electronic medical record system in hospitals at three timing points: 6-15 gestational weeks, 30-34 gestational weeks and one week after delivery.

Eligibility criteria: Inclusion Criteria:

* Pregnant women who registered an antenatal care file at the survey hospital ;
* Signed informed consent.

Exclusion Criteria:

* Participated in any drug or nutritional clinical trial from 3 months before pregnancy to recruitment.

Primary outcomes:
measure: adverse maternal outcomes
timeFrame: 40 weeks
measure: adverse neonatal outcomes
timeFrame: 40 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Chongqing
country: China
facility: Chongqing Health center for women and Children
state: Chongqing
city: Xiamen
country: China
facility: Xiamen Maternal and Child Care Hospital
state: Fujian
city: Wuhan
country: China
facility: Hubei Maternal and Child Care Hospital
state: Hubei
city: Yanan
country: China
facility: Yanan University Affiliated Hospital
state: Shanxi
city: Chengdu
country: China
facility: The West China Second University Hospital
state: Sichuan
city: Hangzhou
country: China
facility: Women'S Hospital School of Medicine Zhejiang University
state: Zhejiang
Study officials:
affiliation: West China Hospital
name: Xin Sun, Doctor
role: STUDY_CHAIR
References:
citation: Haider BA, Olofin I, Wang M, Spiegelman D, Ezzati M, Fawzi WW; Nutrition Impact Model Study Group (anaemia). Anaemia, prenatal iron use, and risk of adverse pregnancy outcomes: systematic review and meta-analysis. BMJ. 2013 Jun 21;346:f3443. doi: 10.1136/bmj.f3443.