Anemia, Iron-DeficiencyEIDACPWNCT02887963
Epidemiological Study of Iron Deficiency and Iron Deficiency Anemia in Chinese Pregnant Women
An observational study of Anemia, Iron-Deficiency, run by West China Hospital at 1 site in China.
Trial summary
The purpose of this study is to know the prevalence of iron deficiency (ID) and iron deficiency anemia (IDA) among pregnant women in Chinese urban district at present, and to analyze the epidemiological characteristics of ID/IDA and influencing factors. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Anemia, Iron-Deficiency
- How many people
- 12,000 participants
- Where
- 1 siteChina
- Study dates
- Sep 2016to Jan 2017
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Chinese pregnant women receiving outpatient service at selected hospitals
Who may be able to join
- Receive outpatient service at selected hospitals for the first time during the survey period;
- Sign an informed consent form;
- At selected hospitals, establish registry of personal file for obstetric examination, or ensure regular follow-up.
Who cannot join
- Participate in any clinical trial of medicine or nutrition from 3 months before pregnancy till survey time.
Trial locations and contacts
1 site in 1 country.
China1 site
Chinese Evidence-based Medicine Centre, West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
About this study
Official title: Epidemiological Study of Iron Deficiency and Iron Deficiency Anemia Among Pregnant Women: A National Multicenter Survey in China
The purpose of this study is to know the prevalence of iron deficiency (ID) and iron deficiency anemia (IDA) among pregnant women in Chinese urban district at present, and to analyze the epidemiological characteristics of ID/IDA and influencing factors.
Read the detailed description
This is a national large-scale multi-center cross-sectional survey aimed at investigating the epidemiology of iron deficiency (ID) and iron deficiency anemia (IDA) among Chinese pregnant women in the real world at present, which is anticipated to complete enrollment in two months. A total of 24 hospitals are selected from 6 regions (north, northeast, east, south, southwest, and northwest) of China by the method of multi-stage stratified sampling, each region with one tertiary teaching hospital and three general hospital or health care hospital for women and children. According to the sample size calculation formula combined with the feasibility and flexibility of study, 12000 eligible outpatient pregnant women are expected to be enrolled. Structured questionnaires, which are needed filled in both by patients and doctors, are used to collect participants' data, including basic demographic characteristics (age, occupation, educational level, family income, etc.), reproductive factors (menstrual history, times of pregnancy or parity, history of cesarean section, etc.), pre-pregnancy weight, pregnancy comorbidities and complications, laboratory test of blood routine and serum iron protein, use of iron supplements, diet and living habits during pregnancy, and others. The outcomes are defined by the recommendations on the guidelines for the diagnosis and treatment of Chinese iron deficiency and iron deficiency anemia during gestation period in 2014. All these data are requested to input the electronic data collecting (EDC) system in time and managed level-to-level, with Chinese Evidence-based Medicine Centre finally monitoring the quality of data. During the whole course, no intervention is given to the participants and thus will not have a negative effect on the health and rights of the participants.
- Conditions
- Anemia, Iron-Deficiency
- Keywords
- Iron Deficiency, Iron Deficiency Anemia, Pregnant Women, Gestation, China, Epidemiology
- Medical subject headings
- Anemia, Iron-Deficiency, Iron Deficiencies
What is being measured
The primary outcome is the main question the study is designed to answer.
Iron Deficiency (ID)
serum ferritin concentration less than 20 μg/L
Measured: two months
Iron Deficiency Anemia (IDA)
serum ferritin concentration less than 20 μg/L and hemoglobin less than 110 g/L
Measured: two months
Secondary outcomes (1)
Use of iron supplements
Iron agent type, dose and duration for preventing or treating ID/IDA
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionNov 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia, Iron-DeficiencyStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 12,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- West China Second University Hospital, Sichuan Provincial Hospital for Women and Children, Panzhihua Central Hospital, Chongqing Medical Center for Women and Children, Women's Hospital School Of Medicine Zhejiang University, Xiamen Medical Center for Women and Children, Wenzhou People's Hospital, Suzhou Municipal Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Maternal and Child Health Hospital of Hubei Province, The First Affiliated Hospital of Zhengzhou University, First Affiliated Hospital of Guangxi Medical University, Shanxi Provincial Maternity and Children's Hospital, The Second Affiliated Hospital of Shaanxi University of Chinese Medicine, Yan'an University Affiliated Hospital, Xinjiang Provincial Hospital for Women and Children, Shengjing Hospital, Dalian Maternity and Child Care Hospital, Changchun Obstetrics and Gynecology Hospital, The Fourth Affiliated Hospital of Harbin Medical University, Beijing Obstetrics and Gynecology Hospital, Tianjin Central Hospital of Gynecology Obstetrics, The Fourth Hospital of Shijiazhuang, Beijing Friendship Hospital
- Responsible party
- Principal investigator, Jing Tan, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02887963
- Sponsor's protocol ID
- IDA-China-2016
- Acronym
- EIDACPW
- Status last verified
- Mar 2017
- First submitted
- 29 Aug 2016
- Last updated
- 27 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Study of Iron Deficiency and Iron Deficiency Anemia Among Pregnant Women: A National Multicenter Survey in China
- ClinicalTrials.gov ID
- NCT02887963
- Acronym / sponsor ID
- EIDACPW / IDA-China-2016
- Conditions
- Anemia, Iron-Deficiency
- Keywords
- Iron Deficiency, Iron Deficiency Anemia, Pregnant Women, Gestation, China, Epidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,000 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Collaborators
- West China Second University Hospital, Sichuan Provincial Hospital for Women and Children, Panzhihua Central Hospital, Chongqing Medical Center for Women and Children, Women's Hospital School Of Medicine Zhejiang University, Xiamen Medical Center for Women and Children, Wenzhou People's Hospital, Suzhou Municipal Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Maternal and Child Health Hospital of Hubei Province, The First Affiliated Hospital of Zhengzhou University, First Affiliated Hospital of Guangxi Medical University, Shanxi Provincial Maternity and Children's Hospital, The Second Affiliated Hospital of Shaanxi University of Chinese Medicine, Yan'an University Affiliated Hospital, Xinjiang Provincial Hospital for Women and Children, Shengjing Hospital, Dalian Maternity and Child Care Hospital, Changchun Obstetrics and Gynecology Hospital, The Fourth Affiliated Hospital of Harbin Medical University, Beijing Obstetrics and Gynecology Hospital, Tianjin Central Hospital of Gynecology Obstetrics, The Fourth Hospital of Shijiazhuang, Beijing Friendship Hospital
- Study start
- Sep 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 2 Sep 2016 (estimated)
- 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.
The purpose of this study is to know the prevalence of iron deficiency (ID) and iron deficiency anemia (IDA) among pregnant women in Chinese urban district at present, and to analyze the epidemiological characteristics of ID/IDA and influencing factors.
Detailed description
This is a national large-scale multi-center cross-sectional survey aimed at investigating the epidemiology of iron deficiency (ID) and iron deficiency anemia (IDA) among Chinese pregnant women in the real world at present, which is anticipated to complete enrollment in two months. A total of 24 hospitals are selected from 6 regions (north, northeast, east, south, southwest, and northwest) of China by the method of multi-stage stratified sampling, each region with one tertiary teaching hospital and three general hospital or health care hospital for women and children. According to the sample size calculation formula combined with the feasibility and flexibility of study, 12000 eligible outpatient pregnant women are expected to be enrolled. Structured questionnaires, which are needed filled in both by patients and doctors, are used to collect participants' data, including basic demographic characteristics (age, occupation, educational level, family income, etc.), reproductive factors (menstrual history, times of pregnancy or parity, history of cesarean section, etc.), pre-pregnancy weight, pregnancy comorbidities and complications, laboratory test of blood routine and serum iron protein, use of iron supplements, diet and living habits during pregnancy, and others. The outcomes are defined by the recommendations on the guidelines for the diagnosis and treatment of Chinese iron deficiency and iron deficiency anemia during gestation period in 2014. All these data are requested to input the electronic data collecting (EDC) system in time and managed level-to-level, with Chinese Evidence-based Medicine Centre finally monitoring the quality of data. During the whole course, no intervention is given to the participants and thus will not have a negative effect on the health and rights of the participants.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Chinese pregnant women receiving outpatient service at selected hospitals
Key inclusion criteria (3 listed)
- Receive outpatient service at selected hospitals for the first time during the survey period;
- Sign an informed consent form;
- At selected hospitals, establish registry of personal file for obstetric examination, or ensure regular follow-up.
Key exclusion criteria (1 listed)
- Participate in any clinical trial of medicine or nutrition from 3 months before pregnancy till survey time.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Iron Deficiency (ID)
Time frame: two months
serum ferritin concentration less than 20 μg/L
Iron Deficiency Anemia (IDA)
Time frame: two months
serum ferritin concentration less than 20 μg/L and hemoglobin less than 110 g/L
1 secondary outcome
Use of iron supplements
Time frame: two months
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 27 Mar 2017.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia, Iron-Deficiency, run by West China Hospital at 1 site 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 3 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 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Iron Deficiency (ID) (time frame: two months). 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?
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 27 Mar 2017.