Not Yet RecruitingPhase 3Phase 4ACTRN12623001163695

Implementation and evaluation of an intravenous iron intervention for pregnant women with anaemia: a demonstration project

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

Sponsor

International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)

Enrollment

2,000 participants

Start Date

Dec 1, 2023

Study Type

Interventional

Conditions

Pregnancy Anaemia

Summary

Maternal anaemia is a significant global health problem, affecting 49% of pregnant women in Asia. The standard of care in Bangladesh is oral iron supplementation. However, access and adherence to oral iron supplementation are subpar. An alternative treatment available to address maternal anaemia is intravenous (IV) iron. Modern IV iron products are routinely used in high-income clinical settings including primary care to deliver a high dose of iron in a single short infusion. A demonstration project will be conducted to test the real-world feasibility and acceptability of implementing an IV iron intervention to treat pregnant women with moderate and severe anaemia in the primary health care setting of Bangladesh. We will use implementation science frameworks to guide the development, implementation and evaluation of the demonstration project. Using a co-design approach with end-users, community members and healthcare workers, we will develop and implement care pathways and strategies to support the uptake and delivery of the IV iron intervention. We will conduct a process evaluation of the IV iron intervention care pathways and strategies involving qualitative and quantitative assessment of the processes and contextual factors affecting its implementation. Understanding how the IV iron intervention will be implemented will inform the scalability of the IV iron intervention, if successful, in the primary healthcare system of Bangladesh and provide implementation guidance in other low and middle income countries.

Eligibility

Sex: FemalesMin Age: 12 Yearss

Inclusion Criteria6

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.

Exclusion Criteria6

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).

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Interventions

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.