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

Completed

• Conditions: Iron Deficiency Anemia of Pregnancy
• Interventions: Other: Iron deficiency anemia in Chinese pregnant women

• Registration Number: NCT03961074
• Lead Sponsor: West China Hospital

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.

Study Timeline

• Study Start: 2019-05-10
• Study First Submitted: 2019-05-21
• Study First Submitted QC: 2019-05-21
• Study First Posted: 2019-05-23
• Primary Completion: 2021-09-30
• Study Completion: 2021-11-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 5551

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Exposure group	Iron deficiency anemia in Chinese pregnant women	Chinese women with iron deficiency anemia (IDA) during pregnancy.

Primary Outcome Measures

Name	Time	Method
adverse maternal outcomes	40 weeks	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.
adverse neonatal outcomes	40 weeks	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.

Trial Locations

Locations (7)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China

Chongqing Health center for women and Children; 🇨🇳 Chongqing, Chongqing, China

Xiamen Maternal and Child Care Hospital; 🇨🇳 Xiamen, Fujian, China

Yanan University Affiliated Hospital; 🇨🇳 Yanan, Shanxi, China

Women'S Hospital School of Medicine Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China

Hubei Maternal and Child Care Hospital; 🇨🇳 Wuhan, Hubei, China

The West China Second University Hospital; 🇨🇳 Chengdu, Sichuan, China