Iron Deficiency Anemia of PregnancyIRONWOMENNCT03961074
Iron Deficiency Anemia Among Chinese Pregnant Women: a Multi-center Prospective Cohort Study
An observational study of Iron Deficiency Anemia of Pregnancy, run by West China Hospital at 7 sites in China.
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency Anemia of Pregnancy
- What is being tested?
- Iron deficiency anemia in Chinese pregnant women
- How many people
- 5,551 participants
- Where
- 7 sitesChina
- Study dates
- 10 May 2019to 30 Nov 2021
- How long will I take part?
- 40 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Chinese pregnant women who established a health record at one of the survey hospital in seven cities of China.
Who may be able to join
- Pregnant women who registered an antenatal care file at the survey hospital ;
- Signed informed consent.
Who cannot join
- Participated in any drug or nutritional clinical trial from 3 months before pregnancy to recruitment.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Peking University People's Hospital
Beijing, Beijing Municipality
The West China Second University Hospital
Chengdu, Sichuan, 610041
Chongqing Health center for women and Children
Chongqing, Chongqing Municipality
Women'S Hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang
Hubei Maternal and Child Care Hospital
Wuhan, Hubei
Xiamen Maternal and Child Care Hospital
Xiamen, Fujian
Yanan University Affiliated Hospital
Yanan, Shanxi
About this study
Official title: Iron Deficiency Anemia Among Chinese Pregnant Women (IRON 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.
Read the 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.
- Conditions
- Iron Deficiency Anemia of Pregnancy
- Being tested
- Iron deficiency anemia in Chinese pregnant women
- Keywords
- Iron Deficiency Anemia, iron supplements, Chinese pregnant women, adverse maternal outcomes, adverse neonatal outcome
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron deficiency anemia in Chinese pregnant womenOther
Iron deficiency anemia exists in Chinese pregnant women during pregnancy
| Study group | Role | What they receive |
|---|---|---|
| Exposure group | Chinese women with iron deficiency anemia (IDA) during pregnancy. Receives: Other: Iron deficiency anemia in Chinese pregnant women | |
| Control group | Chinese women without iron deficiency anemia (IDA) during pregnancy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start10 May 2019
- Primary completion30 Sep 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iron Deficiency Anemia of PregnancyStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,551 participants (actual)
- Target duration
- 40 Weeks
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- West China Second University Hospital
- Responsible party
- Principal investigator, Sun Xin, West China Hospital
- Investigators
- Xin Sun, Doctor, Study chair, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03961074
- Sponsor's protocol ID
- IDA_2019
- Acronym
- IRONWOMEN
- Status last verified
- May 2024
- First submitted
- 21 May 2019
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be shared with other researchers with the agreement of the Coordinating Committee and the Ethics Committee.
Publications
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.
PubMed 23794316
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Deficiency Anemia Among Chinese Pregnant Women (IRON WOMEN): a Multi-center Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03961074
- Acronym / sponsor ID
- IRONWOMEN / IDA_2019
- Conditions
- Iron Deficiency Anemia of Pregnancy
- Keywords
- Iron Deficiency Anemia, iron supplements, Chinese pregnant women, adverse maternal outcomes, adverse neonatal outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,551 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Collaborators
- West China Second University Hospital
- Study start
- 10 May 2019 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 23 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 40 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposure group | – | Other: Iron deficiency anemia in Chinese pregnant womenChinese women with iron deficiency anemia (IDA) during pregnancy. |
| Control group | – | –Chinese women without iron deficiency anemia (IDA) during pregnancy. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Chinese pregnant women who established a health record at one of the survey hospital in seven cities of China.
Key inclusion criteria (2 listed)
- Pregnant women who registered an antenatal care file at the survey hospital ;
- Signed informed consent.
Key exclusion criteria (1 listed)
- Participated in any drug or nutritional clinical trial from 3 months before pregnancy to recruitment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iron deficiency anemia in Chinese pregnant womenIron deficiency anemia exists in Chinese pregnant women during pregnancy | Other | Exposure group |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Background: PubMed 23794316Haider 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.
- Individual participant dataSharing planned: No. Data can be shared with other researchers with the agreement of the Coordinating Committee and the Ethics Committee.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xin Sun, Doctor study chair
West China Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iron Deficiency Anemia of Pregnancy, run by West China Hospital at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adverse maternal outcomes (time frame: 40 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03961074, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024.