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

Sponsor
West China Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03961074
Collaborator
West China Second University Hospital (Other)
6,000
7
19.7
857.1
43.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: 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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
6000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Iron Deficiency Anemia Among Chinese Pregnant Women (IRON WOMEN): a Multi-center Prospective Cohort Study
Actual Study Start Date :
May 10, 2019
Anticipated Primary Completion Date :
Dec 30, 2020
Anticipated Study Completion Date :
Dec 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Exposure group

Chinese women with iron deficiency anemia (IDA) during pregnancy.

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

Control group

Chinese women without iron deficiency anemia (IDA) during pregnancy.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking University People's Hospital Beijing Beijing China
2 Chongqing Health center for women and Children Chongqing Chongqing China
3 Xiamen Maternal and Child Care Hospital Xiamen Fujian China
4 Hubei Maternal and Child Care Hospital Wuhan Hubei China
5 Yanan University Affiliated Hospital Yanan Shanxi China
6 The West China Second University Hospital Chengdu Sichuan China 610041
7 Women'S Hospital School of Medicine Zhejiang University Hangzhou Zhejiang China

Sponsors and Collaborators

  • West China Hospital
  • West China Second University Hospital

Investigators

  • Study Chair: Xin Sun, Doctor, West China Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Sun Xin, Director, West China Hospital
ClinicalTrials.gov Identifier:
NCT03961074
Other Study ID Numbers:
  • IDA_2019
First Posted:
May 23, 2019
Last Update Posted:
Oct 1, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sun Xin, Director, West China Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 1, 2019