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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03961074
Other study ID # IDA_2019
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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