Iron Deficiency Anemia Among Chinese Pregnant Women: a Multi-center Prospective Cohort Study

Iron Deficiency Anemia of Pregnancy Clinical Trial

— IRONWOMEN  

Official title:

Iron Deficiency Anemia Among Chinese Pregnant Women (IRON WOMEN): a Multi-center Prospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03961074
• Other study ID #: IDA_2019
• Status: Completed
• Start date: May 10, 2019
• Est. completion date: November 30, 2021

Study information

• Verified date: May 2024
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5551
• Est. completion date: November 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Deficiency Diseases
• Iron Deficiency Anemia of Pregnancy

Intervention

Other:
• Iron deficiency anemia in Chinese pregnant women
Iron deficiency anemia exists in Chinese pregnant women during pregnancy

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing
China	The West China Second University Hospital	Chengdu	Sichuan
China	Chongqing Health center for women and Children	Chongqing	Chongqing
China	Women'S Hospital School of Medicine Zhejiang University	Hangzhou	Zhejiang
China	Hubei Maternal and Child Care Hospital	Wuhan	Hubei
China	Xiamen Maternal and Child Care Hospital	Xiamen	Fujian
China	Yanan University Affiliated Hospital	Yanan	Shanxi

Sponsors (2)

Lead Sponsor	Collaborator
West China Hospital	West China Second University Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adverse maternal outcomes	Including iron deficiency anemia rate, pregnancy hypertension syndrome rate, gestational diabetes mellitus rate, cesarean section rate, and other adverse maternal outcomes rate. The definition of adverse maternal outcome was according to International Glossary on Infertility and Fertility Care (2017), and the rate of adverse maternal outcome was calculated by the number of adverse maternal outcome divided by the total number of pregnant women.	40 weeks
Primary	adverse neonatal outcomes	Including miscarriage rate, premature birth rate, birth defect rate, low birth weight rate, and other adverse neonatal outcomes. The definitions of adverse neonatal outcomes were according to International Glossary on Infertility and Fertility Care (2017), and the rate of adverse neonatal outcomes were calculated by the number of advers neonatal outcomes divided by the total number of pregnancy or birth.	40 weeks