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NCT Number: NCT03961074

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

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.

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Key information

Conditions

Iron Deficiency Anemia of Pregnancy Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Peking University People's Hospital, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Iron deficiency anemia in Chinese pregnant women

Other

Iron deficiency anemia exists in Chinese pregnant women during pregnancy

Primary outcomes

  1. adverse maternal outcomes

    Time frame: 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.

  2. adverse neonatal outcomes

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Collaborators

  • West China Second University Hospital

Registry information

Official study title

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

Acronym: IRONWOMEN

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 23, 2019
Registry last updated
May 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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