- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03121027
Burden of Anemia Among Ever-married Women in Bangladesh: Does Household Economic Inequality Matter?
Burden of Anemia Among Ever-married Women in Bangladesh
Study Overview
Status
Conditions
Detailed Description
This study was carried out with the approval of ICF International ( Address: 11785 Beltsville Drive Suite 300 Calverton, MD 20705 USA). The data from the 2011 Bangladesh Demographic and Health Survey (BDHS), conducted under the authority of the National Institute of Population Research and Training (NIPORT) of the Ministry of Health and Family Welfare of Bangladesh will be used for this study. Mitra and Associates, a Bangladeshi research firm located in Dhaka implemented the survey and ICF International of Calverton, Maryland, USA, arranged the technical support to the mission as the part of its international Demographic and Health Surveys database (MEASURE DHS). Procedures and questionnaires for standard DHS surveys have been reviewed and approved by the ICF International Institutional Review Board (IRB). (See more at: http://www.dhsprogram.com/What-We-Do/Protecting-the-Privacy-of-DHS-Survey-Respondents.cfm#sthash.qc30dbXO.dpuf) The data collection processes for the BDHS was executed as per the approval of the ORC Macro-institutional review board. The survey protocol was reviewed and approved by the National Ethics Review Committee of the Bangladesh Ministry of Health and Family Welfare. As per BDHS guidelines, informed consent was obtained from all respondents before starting the interview along with an oral clarification offered by the interviewers themselves. Respondents were well informed with regards to the intended use of the gathered data (assessment of health needs and planning health services), the voluntary nature of the study, potential risks of participation in the study, the confidentiality of answers/results of the individual interview and biomarker assay, and that the examination was free of cost. Prior to the blood collection and examination, participants were also well informed about the purpose of the study.
A stratified, multistage cluster sampling strategy was followed in order to construct a national representative household-based sample. To generate this, 600 primary sampling units (207 from urban areas and 393 from rural areas) were raised from the sampling frame created for the 2011 Bangladeshi census. From each primary sampling unit, households were nominated randomly and 17,964 households were selected for interview. Face-to-face interviews were effectively completed among 17,141 selected households. Finally, in these households a total of 18,222 ever married women age 12-49 were identified and 17,842 were interviewed successfully. A total of 5920 ever-married women aged between 15-49 years who resided in one-third of the randomly selected households were selected as subjects for the biomarker assay for anemia study.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Sylhet, Bangladesh, 3114
- Data analysis
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion criteria:
- Ever-married women: Those who get married, divorced and the widow is also included.
- Exclusion criteria:
Not married women: Those who never married.
Study Plan
How is the study designed?
Design Details
- Observational Models: Ecologic or Community
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anemia
Time Frame: Baseline
|
Hemoglobin concentration will be used as the parameter for diagnosing anemia.
For the purpose of this study, "anemia" will be defined as per WHO, 2011 guidelines for the diagnosis of anemia.
Briefly, in the case of pregnant women, a hemoglobin concentration of less than 70 g/L will be used to define severe anemia, between 70-99.99 g/L will be used for defining moderate anemia while 100-109.99
g/L will be consider to correspond to mild anemia (n=372).
In non-pregnant women, a hemoglobin concentration of less than 80 g/L will be used to define severe anemia, 80-109.99
g/L for moderate anemia, and 110-119.99 g/L to correspond to mild anemia.
In accordance with the recommendation of the Center for Disease Prevention of United States, and in agreement with the World Health Organization, the blood assay report for anemia will be adjusted for altitude and smoking during the categorization into "severe" "moderate" or "mild" anemia.
|
Baseline
|
Collaborators and Investigators
Investigators
- Principal Investigator: GM R. Islam, PhD, Shahjalal University of Science and Technology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AW-FET
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Study Data/Documents
-
Individual Participant Data Set
Information comments: Detail about sampling and BDHS 2011 report
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anemia
-
SanofiActive, not recruitingWarm Autoimmune Hemolytic Anemia (wAIHA)United States, Austria, China, Denmark, Germany, Hungary, Italy, Spain, United Kingdom
-
SanofiTerminatedWarm Autoimmune Hemolytic Anemia (wAIHA)United Kingdom, Belgium, Netherlands, France, United States, Germany, Hungary, Italy
-
Hospital Universitario Dr. Jose E. GonzalezCompletedPernicious Anemia | Megaloblastic Anemia NosMexico
-
Assistance Publique - Hôpitaux de ParisNot yet recruitingSevere Aplastic Anemia | Idiopathic Aplastic Anemia | Moderate Aplastic Anemia Requiring Transfusions
-
Abdelwahed, Mai Mahmoud Mohamed, M.D.UnknownAnemia During PregnancyEgypt
-
University of California, DavisInstituto Mexicano del Seguro Social; Thrasher Research Fund; Mexican National... and other collaboratorsCompleted
-
Incyte CorporationActive, not recruitingWarm Autoimmune Hemolytic Anemia (wAIHA)Spain, United States, Austria, Belgium, Canada, France, Germany, Israel, Italy, Japan, Netherlands, Poland, United Kingdom
-
Peking Union Medical College HospitalRecruiting
-
Alexion PharmaceuticalsWithdrawnWarm Autoimmune Hemolytic AnemiaUnited States