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Trial registered on ANZCTR


Registration number
ACTRN12623001163695
Ethics application status
Approved
Date submitted
3/10/2023
Date registered
9/11/2023
Date last updated
9/11/2023
Date data sharing statement initially provided
9/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Implementation and evaluation of an intravenous iron intervention for pregnant women with anaemia: a demonstration project
Scientific title
Implementation and evaluation of an intravenous iron intervention for pregnant women with moderate and severe anaemia in the primary healthcare system of Bangladesh: a demonstration project
Secondary ID [1] 310647 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaemia 331529 0
Iron deficiency 331883 0
Pregnancy 331884 0
Condition category
Condition code
Blood 328269 328269 0 0
Anaemia
Reproductive Health and Childbirth 328270 328270 0 0
Antenatal care
Reproductive Health and Childbirth 328604 328604 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Using a post design of an intervention implementation in a new setting, the demonstration project aims to assess the feasibility and acceptability of an intravenous iron (IV) intervention for pregnant women with moderate and severe anaemia across several care pathways in the primary care setting of Bangladesh. The care pathways and implementation strategies were co-designed with end-users (i.e., pregnant women), community members and healthcare workers.

The IV iron intervention involves two components: 1) anaemia screening and 2) administration of IV iron.
1) Pregnant women in their second or third trimester of pregnancy (week 13 to week 32) will be screened for anaemia using point-of-care testing (i.e., capillary blood by finger prick with hemocue tool). This will be performed by a government healthcare worker with support from a study field worker. Pregnant women found to be moderately-severely anaemic (haemoglobin <10g/dL) will then be referred to receive the IV iron intervention in a primary care setting within 1 week from referral, before 33 completed weeks of pregnancy.
2) Participating pregnant women will receive ferric carboxymaltose – 20mg/kg up to 1000mg (women 50kg or above) in 250mL normal saline – intravenously over 15 minutes. The study drug will be administered by a physician or nurse working in the government health facility. An intravenous cannula will be inserted following standard aseptic procedure. The skin will be cleaned with ethanol, and a sterile cannula will be inserted into the forearm or hand, and the cannula will be fixed in place with a sterile Tegaderm or clinical tape. The participant will be monitored over the 15 minutes of the infusion for any adverse events, and if they develop, these will be attended to promptly and treated according to standard clinical management guidelines. Following completion, the cannula will be removed and placed in a biohazard container, and a band-aid applied to the arm. The participant will be observed for a further 45 minutes. Administration of iron will be done in a room equipped with a ‘crash’ trolley which will contain adrenaline, hydrocortisone, intravenous fluids and antihistamines. The room will also contain airway equipment (laryngoscope and endotracheal tubes) and oxygen, for emergencies.
Intervention code [1] 327053 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336130 0
% pregnant women with identified moderate or severe anaemia in the second or third trimester that received IV iron in primary care
Timepoint [1] 336130 0
end of study (12 months from the opening of the demonstration project)
Secondary outcome [1] 426936 0
feasibility: % pregnant women in the second or third trimester attending primary healthcare facilities
Timepoint [1] 426936 0
mid (6-months) and end of study (12-months from the opening of the demonstration project)
Secondary outcome [2] 426937 0
feasibility: % pregnant women in the second or third trimester approached to be screened for anaemia
Timepoint [2] 426937 0
mid (6-months) and end of study (12-months from the opening of the demonstration project)
Secondary outcome [3] 426938 0
feasibility: % pregnant women in the second or third trimester screened for anaemia
Timepoint [3] 426938 0
mid (6-months) and end of study (12-months from the opening of the demonstration project)
Secondary outcome [4] 426939 0
feasibility: % pregnant women diagnosed with moderate or severe anaemia
Timepoint [4] 426939 0
mid (6-months) and end of study (12-months from the opening of the demonstration project)
Secondary outcome [5] 426940 0
feasibility: % pregnant women with moderate or severe anaemia referred for IV iron treatment
Timepoint [5] 426940 0
mid (6-months) and end of study (12-months from the opening of the demonstration project)
Secondary outcome [6] 426941 0
feasibility: anaemia screening and IV iron intervention implementation feasibility amongst government healthcare workers
Timepoint [6] 426941 0
all government healthcare workers participating in the demonstration project will be invited to complete the questionnaire at mid (6-months) and end of study (12-months from the opening of the demonstration project)
Secondary outcome [7] 426942 0
feasibility: self-reported factors (individual readiness, contextual and processes) affecting implementation ease or difficulty amongst government healthcare workers
Timepoint [7] 426942 0
a sample of government healthcare workers participating in the demonstration project will be invited to participate in the interview at mid (6-months) and end of study (12-months from the opening of the demonstration project)
Secondary outcome [8] 426943 0
acceptability: % pregnant women with moderate or severe anaemia who dropout (i.e. screened for anaemia and referred for IV iron but did not received IV iron) across each care pathway
Timepoint [8] 426943 0
mid (6-months) and end of study (12-months from the opening of the demonstration project)
Secondary outcome [9] 426944 0
acceptability: % pregnant women with moderate or severe anaemia who opted for oral iron instead of IV iron across each care pathway
Timepoint [9] 426944 0
mid (6-months) and end of study (12-months from the opening of the demonstration project)
Secondary outcome [10] 426945 0
acceptability: % adverse events and serious adverse events during IV iron administration
Timepoint [10] 426945 0
mid (6-months) and end of study (12-months from the opening of the demonstration project)
Secondary outcome [11] 426946 0
acceptability: acceptability of anaemia screening and IV iron intervention amongst government healthcare workers
Timepoint [11] 426946 0
all government healthcare workers participating in the demonstration project will be invited to complete the questionnaires at mid (6-months) and end of study (12-months from the opening of the demonstration project)
Secondary outcome [12] 426947 0
acceptability: acceptability of anaemia screening and IV iron amongst pregnant women
Timepoint [12] 426947 0
all pregnant women will be invited to complete the questionnaire directly following anaemia screening and administration of IV iron
Secondary outcome [13] 426948 0
acceptability: pregnant women with moderate or severe anaemia perception of the IV iron intervention (cultural barriers, side effects), implementation strategies and unintended consequences
Timepoint [13] 426948 0
a sample of pregnant women participating in the demonstration project (screened for anaemia and received IV iron) for the first 6 months will be invited to participate in the interview at mid (6-months), and a separate sample of pregnant women participating in the last 6 months of the demonstration project will be invited to participate in the interview at the end of study (12-months from the opening of the demonstration project)
Secondary outcome [14] 426949 0
acceptability: government healthcare workers perception of the IV iron intervention, implementation process, implementation strategies and unintended consequences
Timepoint [14] 426949 0
a sample of government healthcare workers participating in the demonstration project will be invited to participate in the interview at mid (6-months) and end of study (12-months from the opening of the demonstration project)
Secondary outcome [15] 426950 0
fidelity: % adherence to the screening protocol
Timepoint [15] 426950 0
All government healthcare workers participating in the demonstration project will be invited to complete the checklist at mid (6-months) and end of study (12-months from the opening of the demonstration project) for several weeks. Direct observation will be conducted on a subset of government healthcare workers at mid (6-months) and end of study (12 months) for several weeks.
Secondary outcome [16] 426951 0
fidelity: % adherence to the delivery of IV iron protocol
Timepoint [16] 426951 0
All government healthcare workers participating in the demonstration project will be invited to complete the checklist at mid (6-months) and end of study (12-months from the opening of the demonstration project) for several weeks. Direct observation will be conducted on a subset of government healthcare workers at mid (6-months) and end of study (12 months) for several weeks.
Secondary outcome [17] 426952 0
fidelity: time intervals between anaemia screening and receiving IV iron treatment
Timepoint [17] 426952 0
mid (6-months) and end of study (12-months from the opening of the demonstration project)
Secondary outcome [18] 426953 0
fidelity: N government healthcare workers who screened for anaemia
Timepoint [18] 426953 0
mid (6-months) and end of study (12-months from the opening of the demonstration project)
Secondary outcome [19] 426954 0
fidelity: N government healthcare workers who delivered the IV iron
Timepoint [19] 426954 0
mid (6-months) and end of study (12-months from the opening of the demonstration project)
Secondary outcome [20] 426955 0
fidelity: average time for anaemia screening
Timepoint [20] 426955 0
All government healthcare workers participating in the demonstration project will be invited to complete the checklist at mid (6-months) and end of study (12-months from the opening of the demonstration project) for several weeks. Direct observation will be conducted on a subset of government healthcare workers at mid (6-months) and end of study (12 months) for several weeks.
Secondary outcome [21] 426956 0
fidelity: average time for delivery of IV iron
Timepoint [21] 426956 0
All government healthcare workers participating in the demonstration project will be invited to complete the checklist at mid (6-months) and end of study (12-months from the opening of the demonstration project) for several weeks. Direct observation will be conducted on a subset of government healthcare workers at mid (6-months) and end of study (12 months) for several weeks.
Secondary outcome [22] 426957 0
fidelity: average time for monitoring following delivery of IV iron
Timepoint [22] 426957 0
All government healthcare workers participating in the demonstration project will be invited to complete the checklist at mid (6-months) and end of study (12-months from the opening of the demonstration project) for several weeks. Direct observation will be conducted on a subset of government healthcare workers at mid (6-months) and end of study (12 months) for several weeks.
Secondary outcome [23] 426958 0
fidelity: adaptations made to the intervention components
Timepoint [23] 426958 0
All government healthcare workers participating in the demonstration project will be invited to complete the checklist at mid (6-months) and end of study (12-months from the opening of the demonstration project) for several weeks. Direct observation will be conducted on a subset of government healthcare workers at mid (6-months) and end of study (12 months) for several weeks. A sample of government healthcare workers will also be invited to participate in the interview at mid (6-months) and end of study (12-months).
Secondary outcome [24] 426959 0
fidelity: quality of program delivery
Timepoint [24] 426959 0
All government healthcare workers participating in the demonstration project will be invited to complete the checklist at mid (6-months) and end of study (12-months from the opening of the demonstration project) for several weeks. Direct observation will be conducted on a subset of government healthcare workers at mid (6-months) and end of study (12 months) for several weeks. A sample of government healthcare workers and pregnant women (screened for anaemia and received IV iron) will also be invited to participate in the interview at mid (6-months) and end of study (12-months).

Eligibility
Key inclusion criteria
• Pregnant women in the second or third trimester (13-32 weeks of gestation, dated by last menstrual period).
• Moderate to severe anaemia not requiring an immediate blood transfusion (Hb <10g/dL).
• Not known to have a diagnosis of thalassemia or other inherited red cell condition.
• Not known to have a prior allergy to intravenous iron.
• Clinically afebrile with no evidence of systemic infection.
• Resident in the study catchment area.
Minimum age
12 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• Previous enrolment in EDIVA efficacy trial.
• Actively participating in another intervention trial.
• Known hypersensitivity to any of the study drugs.
• Any condition requiring hospitalisation in the next seven days or serious concomitant illness.
• Known history of thalassemia or other inherited red cell condition.
• Clinically low haemoglobin level requiring a blood transfusion (Hb <5g/dL).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Statistical methods / analysis
The sample size calculation for feasibility outcomes is based on a minimum of two care pathways that will be implemented in the demonstration project over a one-year period with a process evaluation halfway. We assumed in a five-month implementation period (excluding first month for transition period) that 470 and 356 pregnant women will be identified in the pregnancy register book for pathway 1 and pathway 2 respectively, and that 90% of these pregnant women will be screened for anaemia. Of these, 13% of screened pregnant women will have moderate or severe anaemia (hb <10g/dl) at one of these screenings. We expect approximately 55 and 42 women to be referred for IV iron infusion in each pathway. This sample will be sufficient to obtain a 95% confidence interval (CI) with total widths of 14% and 16% around an estimate of 95% of all referrals leading to an IV iron infusion (i.e., 95% CI 85%-99%: and 95% CI: 84%-99%).

Binomial exact (Clopper-Pearson) 95% CIs for a single proportion will be used to obtain CIs for the primary feasibility outcome (percentage of referrals that culminate in IV iron infusions) and each binary quantitative outcome; means and 95% CIs will be reported for secondary continuous quantitative outcomes (such as time for delivery of IV iron). Descriptive statistics (means and standard deviations; proportions) will be used to summarise study participants. Quantitative analysis will be performed using Stata 17.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2023
Actual
Date of last participant enrolment
Anticipated
1/12/2024
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
2000
Accrual to date
Final
Recruitment outside Australia
Country [1] 25777 0
Bangladesh
State/province [1] 25777 0

Funding & Sponsors
Funding source category [1] 314861 0
Charities/Societies/Foundations
Name [1] 314861 0
Bill and Melinda Gates Foundation
Country [1] 314861 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] 316855 0
Other Collaborative groups
Name [1] 316855 0
Walter and Eliza Hall Institute
Address [1] 316855 0
1G Royal Parade Parkville VIC 3052
Country [1] 316855 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313861 0
International Centre for Diarrhoeal Disease Research, Bangladesh Ethical Review Committee
Ethics committee address [1] 313861 0
Ethics committee country [1] 313861 0
Bangladesh
Date submitted for ethics approval [1] 313861 0
21/03/2021
Approval date [1] 313861 0
29/03/2021
Ethics approval number [1] 313861 0
PR-20125
Ethics committee name [2] 313863 0
Walter and Eliza Hall Institute Human Research Ethics Committee
Ethics committee address [2] 313863 0
Ethics committee country [2] 313863 0
Australia
Date submitted for ethics approval [2] 313863 0
04/03/2021
Approval date [2] 313863 0
02/06/2021
Ethics approval number [2] 313863 0
21/5

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129590 0
Prof Sant-Rayn Pasricha
Address 129590 0
Population Health and Immunity/ Infection and Immunity Divisions, The Walter and Eliza Hall Institute of Medical Research, 1G Royal Parade Parkville VIC 3052
Country 129590 0
Australia
Phone 129590 0
+61 393452618
Fax 129590 0
Email 129590 0
[email protected]
Contact person for public queries
Name 129591 0
Sant-Rayn Pasricha
Address 129591 0
Population Health and Immunity/ Infection and Immunity Divisions, The Walter and Eliza Hall Institute of Medical Research, 1G Royal Parade Parkville VIC 3052
Country 129591 0
Australia
Phone 129591 0
+61 393452618
Fax 129591 0
Email 129591 0
[email protected]
Contact person for scientific queries
Name 129592 0
Sant-Rayn Pasricha
Address 129592 0
Population Health and Immunity/ Infection and Immunity Divisions, The Walter and Eliza Hall Institute of Medical Research, 1G Royal Parade Parkville VIC 3052
Country 129592 0
Australia
Phone 129592 0
+61 393452618
Fax 129592 0
Email 129592 0
[email protected]

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 surveys data. Transcripts of interviews will not be shared due to risks of re-identification of participants.
When will data be available (start and end dates)?
At least one year following publication of the demonstration project. There is no end date for when data will be available.
Available to whom?
Researchers who provide a methodologically sound proposal and complete 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 ([email protected])


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.