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Trial registered on ANZCTR


Registration number
ACTRN12621000982819
Ethics application status
Approved
Date submitted
18/06/2021
Date registered
26/07/2021
Date last updated
26/07/2021
Date data sharing statement initially provided
26/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The prevalence of anaemia during the second or third trimester of pregnancy in Bangladesh: a cross-sectional study
Scientific title
The prevalence of anaemia during the second or third trimester of pregnancy in Bangladesh: a cross-sectional study
Secondary ID [1] 304484 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anaemia 322328 0
Iron deficiency 322329 0
Condition category
Condition code
Blood 320001 320001 0 0
Anaemia
Diet and Nutrition 320002 320002 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This will be a an observational study to determine the prevalence of anaemia (haemoglobin <11g/dL) and iron deficiency (ferritin <15mg/L) in pregnant women during the second and third trimester in Bangladesh.

A study physician or technician will collect a 5ml venous blood sample from study participants. Study physicians will also conduct a physical examination checking for pallor, blood pressure, oedema and anthropometric measurements (height, weight, mid-upper arm circumference). Study staff will ask participants to complete surveys on their demographic details, socioeconomic status, current and previous pregnancy information, household food security, knowledge, attitudes and practices for anaemia management, and COVID-19 history. Water, sanitation and hygiene (WASH) and Edinburgh Postnatal Depression Scale questionnaires will also be conducted by study staff.

This will be a cross-sectional survey and so all the activities outlined above will take place once, during a single assessment per participant. We anticipate this study will be conducted over 3 months.
Intervention code [1] 320847 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327870 0
Prevalence of anaemia (haemoglobin <11g/dL) during the second or third trimester (13-32 weeks) of pregnancy, measured using a HemoCue301 portable hemoglobin analyzer.

The prevalence of anaemia for both trimester cohorts will be assessed as a composite primary outcome.
Timepoint [1] 327870 0
Samples and data will be collected at a single timepoint per participant, during the second or third trimester (13-32 weeks) of pregnancy.
Secondary outcome [1] 396822 0
Prevalence of iron deficiency (ferritin <15mg/L) during the second or third trimester (13-32 weeks) of pregnancy, measured by enzyme-linked immunosorbent assays (ELISAs) for serum ferritin.

The prevalence of iron deficiency for both trimester cohorts will be assessed as a composite primary outcome.
Timepoint [1] 396822 0
Samples and data will be collected at a single timepoint per participant, during the second or third trimester (13-32 weeks) of pregnancy.

Eligibility
Key inclusion criteria
Pregnant women in their second or third trimester (13-32 weeks of gestation, dated by Last Menstrual Period).
Resident in the study catchment area.
Minimum age
14 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants unwilling or unable to provide informed consent.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
We will screen up to 1500 pregnant women (500 in each Upazila (sub-district)). 40% will be recruited from each of the second and third trimesters respectively. The remaining 20% will be recruited from either trimester. With a minimum sample size of 600 women across all Upazilas (sub-districts) per trimester, the precision of the two-sided 95% confidence interval of the true underlying prevalence is at most ±4% (assuming prevalence of 50%) using the Wald method to measure the two-sided 95% confidence interval. The expected precision is ±3.8% assuming the prevalence of anaemia in pregnancy is (210/600) 35% (i.e. 95% CI 31.2% to 38.8%), ±2.4% assuming the prevalence of moderate/severe anaemia in pregnancy is (60/600) 10% (i.e. 95% CI 7.6% to 12.4%), and ±3.9% assuming the prevalence of iron deficiency in pregnancy is (240/600) 40% (i.e. 95% CI 36.1% to 43.9%).

A detailed statistical analysis plan for the final analysis will be drawn up during the course of the study and finalised before the locking of the data base. Data will be analysed using STATA (StataCorp, Statistical Software: College Station, TX). The proportion of women with anaemia, and iron deficiency will be obtained per trimester, along with two-sided 95% confidence intervals.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 23783 0
Bangladesh
State/province [1] 23783 0
Narayangonj district

Funding & Sponsors
Funding source category [1] 308845 0
Charities/Societies/Foundations
Name [1] 308845 0
Bill and Melinda Gates Foundation
Address [1] 308845 0
500 5th Ave N, Seattle, WA 98109, United States
Country [1] 308845 0
United States of America
Primary sponsor type
Other Collaborative groups
Name
International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)
Address
68, Shaheed Tajuddin Ahmed Sarani Mohakhali, Dhaka 1212, Bangladesh
Country
Bangladesh
Secondary sponsor category [1] 309799 0
None
Name [1] 309799 0
Address [1] 309799 0
Country [1] 309799 0
Other collaborator category [1] 281862 0
Other Collaborative groups
Name [1] 281862 0
Walter and Eliza Hall Institute
Address [1] 281862 0
1G Royal Parade
Parkville VIC 3052
Country [1] 281862 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308752 0
International Centre for Diarrhoeal Disease Research, Bangladesh Ethical Review Committee
Ethics committee address [1] 308752 0
68, Shaheed Tajuddin Ahmed Sarani Mohakhali, Dhaka 1212, Bangladesh
Ethics committee country [1] 308752 0
Bangladesh
Date submitted for ethics approval [1] 308752 0
25/03/2021
Approval date [1] 308752 0
29/03/2021
Ethics approval number [1] 308752 0
PR-20125
Ethics committee name [2] 308761 0
Walter and Eliza Hall Institute Human Research Ethics Committee
Ethics committee address [2] 308761 0
1G Royal Parade, Parkville VIC 3052
Ethics committee country [2] 308761 0
Australia
Date submitted for ethics approval [2] 308761 0
04/03/2021
Approval date [2] 308761 0
02/06/2021
Ethics approval number [2] 308761 0
21/5

Summary
Brief summary
Background: Anaemia in pregnancy is a major public health problem globally that has adverse effects on maternal and neonatal health outcomes. The primary cause of anaemia in pregnancy is iron deficiency. Currently, there is a paucity of data on the prevalence of anaemia and iron deficiency in pregnant women in Bangladesh.

Objective: To determine the prevalence of anaemia (haemoglobin <11g/dL) and iron deficiency (ferritin <15mg/L) during the second and third trimester (13-32 weeks) of pregnancy in women from three Upazilas (sub-districts) in the Narayanganj district of Bangladesh.

Methods: This will be a cross-sectional survey. Pregnant women in their second or third trimester will be identified from the Family Welfare Centre register, which routinely screens women for pregnancy in this setting, and approached to participate in this study. After obtaining informed consent, study staff will collect participant’s demographic information and a blood sample. Up to 1500 pregnant women across 3 Upazilas (sub-districts) of the Narayanganj district of Bangladesh will be screened for anaemia and iron deficiency.

The role of this cross-sectional survey in informing future randomised controlled trial in this study setting: This anaemia prevalence survey will also ensure that we have selected an appropriate site for a future randomised clinical trial to determine the effectiveness of treating moderate and severe anaemia during second and third trimester of pregnancy with an intravenous iron formulation, compared to the standard of care of oral iron supplementation. This randomised controlled trial will be registered separately with the ANZCTR.

This is a collaborative effort between the International Centre for Diarrhoeal Disease Research, Bangladesh, and the Walter and Eliza Hall Institute (Melbourne, Australia).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111770 0
Dr Sant-Rayn Pasricha
Address 111770 0
Population Health and Immunity/ Infection and Immunity Divisions
The Walter and Eliza Hall Institute of Medical Research
1G Royal Parade
Parkville VIC 3052
Australia
Country 111770 0
Australia
Phone 111770 0
+61393452618
Fax 111770 0
Email 111770 0
pasricha.s@wehi.edu.au
Contact person for public queries
Name 111771 0
Dr Sant-Rayn Pasricha
Address 111771 0
Population Health and Immunity/ Infection and Immunity Divisions
The Walter and Eliza Hall Institute of Medical Research
1G Royal Parade
Parkville VIC 3052
Australia
Country 111771 0
Australia
Phone 111771 0
+61393452618
Fax 111771 0
Email 111771 0
pasricha.s@wehi.edu.au
Contact person for scientific queries
Name 111772 0
Dr Sant-Rayn Pasricha
Address 111772 0
Population Health and Immunity/ Infection and Immunity Divisions
The Walter and Eliza Hall Institute of Medical Research
1G Royal Parade
Parkville VIC 3052
Australia
Country 111772 0
Australia
Phone 111772 0
+61393452618
Fax 111772 0
Email 111772 0
pasricha.s@wehi.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data underlying published results
When will data be available (start and end dates)?
After one year following publication of the primary analysis.
There is no end date for when data will be available.
Available to whom?
Researchers who provide a methodologically sound proposal and completed a data request form
Available for what types of analyses?
To achieve aims in the approved proposal
How or where can data be obtained?
Access subject to approval by the Principal Investigator:
Dr Sant-Rayn Pasricha (pasricha.s@wehi.edu.au)
What supporting documents are/will be available?
No other documents available
Summary results
No Results