NCT03961074

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,551

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Typical duration for all trials

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 10, 2019

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

May 7, 2024

Status Verified

May 1, 2024

Enrollment Period

2.4 years

First QC Date

May 21, 2019

Last Update Submit

May 6, 2024

Conditions

Keywords

Iron Deficiency Anemiairon supplementsChinese pregnant womenadverse maternal outcomesadverse neonatal outcome

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Exposure group

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

Other: Iron deficiency anemia in Chinese pregnant women

Control group

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

Interventions

Iron deficiency anemia exists in Chinese pregnant women during pregnancy

Exposure group

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Chinese pregnant women who established a health record at one of the survey hospital in seven cities of China.

You may qualify if:

  • Pregnant women who registered an antenatal care file at the survey hospital ;
  • Signed informed consent.

You may not qualify if:

  • Participated in any drug or nutritional clinical trial from 3 months before pregnancy to recruitment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Peking University People's Hospital

Beijing, Beijing Municipality, China

Location

Chongqing Health center for women and Children

Chongqing, Chongqing Municipality, China

Location

Xiamen Maternal and Child Care Hospital

Xiamen, Fujian, China

Location

Hubei Maternal and Child Care Hospital

Wuhan, Hubei, China

Location

Yanan University Affiliated Hospital

Yanan, Shanxi, China

Location

The West China Second University Hospital

Chengdu, Sichuan, 610041, China

Location

Women'S Hospital School of Medicine Zhejiang University

Hangzhou, Zhejiang, China

Location

Related 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.

    PMID: 23794316BACKGROUND

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Xin Sun, Doctor

    West China Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
40 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

May 21, 2019

First Posted

May 23, 2019

Study Start

May 10, 2019

Primary Completion

September 30, 2021

Study Completion

November 30, 2021

Last Updated

May 7, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Data can be shared with other researchers with the agreement of the Coordinating Committee and the Ethics Committee.

Locations