The Fatigue after Infusion or Transfusion (FIT) Pilot Trial and Feasibility Study
The FIT Pilot Trial and Feasibility Study: a three-armed randomised pilot trial of intravenous iron versus blood transfusion for the treatment of moderate-to-severe postpartum anaemia and feasibility surveys.
Liggins Institute, University of Auckland
20 participants
Sep 1, 2022
Interventional
Conditions
Summary
Currently, the treatment options for clinically stable women with moderate-to-severe postpartum anaemia (PPA, haemoglobin (Hb) <90 g/L) are largely between intravenous iron (IV-iron), red blood cell transfusion (RBC-T), or a combination of both. Our recent observational study found regional variation in the management of moderate-to-severe PPA, including by ethnicity. Overall, Maori and Pacific women had more anaemia before and after birth, and received more IV-iron and less RBC-T than European women. A lack of high-quality evidence on the comparative effectiveness and risks of treatment approaches for women with moderate-to-severe PPA is likely to be a significant contributor to the inconsistency in clinical management. This lack of high-quality evidence includes women-centred outcomes linked to PPA, such as fatigue, postnatal depression and breastfeeding, as well as haematological outcomes. These outcomes are important because the impact of fatigue, postnatal depression and impaired breastfeeding may have long-term consequences for mothers and babies. To create gold-standard evidence to direct future practice, an appropriately powered randomised trial is needed and should explore outcomes of importance to women, as well as to healthcare practitioners and service providers. However, there are indications that recruitment to a randomised trial may be challenging. We are therefore planning the FIT Pilot Trial and Feasibility Study to further understand the enablers and barriers to participation and to optimise the success of a larger, future FIT Trial. We have applied a health equity lens in the planning of the FIT Pilot Trial, to maximise participation for all women with PPA especially those who currently have less advantage in this area. The research aim is to assess the feasibility of the FIT Trial and to optimise future study design by undertaking the FIT Pilot Trial and Feasibility Study. The research question is: Can we recruit women and health care professionals to participate in a three-armed trial of IV iron alone, IV-iron and RBC-T in combination, or RBC-T alone, for clinically stable women with moderate-to-severe PPA? The primary objective is to determine the number of women willing to be recruited, and the recruitment rate, to a three-armed randomised trial of IV-iron, IV-iron and RBC-T or RBC-T.
Eligibility
Inclusion Criteria6
- Postpartum women with liveborn babies less than or equal to 20 weeks gestation, regardless of mode of birth, at participating sites.
- Within one week (less than or equal to 7 days) of birth
- Any Hb 65-79 g/L
- Clinically stable as determined by the treating clinician
- Suitable to receive either IV-iron and/or RBC-T as determined by treating clinician
- Able to provide informed consent
Exclusion Criteria10
- Ongoing heavy bleeding
- Already received IV-iron and/or RBC-T as a treatment for peripartum and/or PPA
- Aged <16 years
- Religious, cultural or other objections to RBC-T or IV-iron
- IV-iron in preceding month
- History of anaemia other than iron-deficiency anaemia i.e. thalassemia or other haemoglobinopathies
- Haemochromatosis
- Known contraindications and precautions to IV-iron: history of hypersensitivity to IV-iron; iron overload (or disturbance in utilisation of iron), bacteremia, hypophosphataemia or hepatic or renal impairment
- Renal impairment, history of cardiac or respiratory failure, heart surgery, organ transplant.
- RBC-T contraindicated i.e. history of previous serious reaction to RBC-T
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Interventions
Women will be randomised to one of three groups. Arm B and Arm C are the intervention arms: Arm B. Red blood cell transfusion (RBC-T). The number of units of RBCs to be determined by the responsible clinician and given within 24 hours of randomisation. Arm C. Intravenous iron (IV-iron) and RBC-T. Single dose of 1000mg dose of ferric carboxymaltose (FCM) and RBC-T with the number of units of RBCs to be determined by the responsible clinician. IV-iron and RBC-T to be administered within 24 hours of of randomisation. Interventions will be administered by registered midwives and nurses, as per the normal standard of care. FCM will be administered intravenously as an infusion according to local hospital protocol. Manufacturer instructions recommend it should be diluted in 250mL of sterile 0.9% sodium chloride solution and infused over 15 minutes. Vital signs of women should be closely monitored and documented before, during, and after FCM administration according to local hospital policy. The total iron requirements for FCM have been shown to be less than or equal to 1600mg for approximately 90% of postpartum women, therefore a fixed single 1000mg dose of FCM has been chosen (1). This dose selection is supported by Medsafe advice of a single FCM not exceeding 1000mg, or up to a maximum of 20mg/kg body weight (2). RBC-T should be administered with appropriate monitoring as per each hospital protocol. Relevant concomitant care permitted or prohibited: Oral iron supplementation may be prescribed according to local hospital guidelines, as determined by the responsible clinician. Where local guidance is not available, it is recommended that oral iron should not given in addition to the study interventions. When oral iron is given, data regarding the prescription and use of oral iron will be collected. A study-specific log will be kept for each participant to monitor adherence to the intervention. Where a clinician prescribes an additional intervention (IV-iron or RBC-T) contrary to randomisation allocation this will be considered a protocol violation (by the Lead Investigator or Senior Supervising Investigator). Data regarding the use of additional IV-iron and RBC-T will be collected along with the reasons why, to inform future trial planning or the likelihood of protocol violation/crossover of treatment. (1) Seid MH, Butcher AD, Chatwani A. Ferric Carboxymaltose as Treatment in Women with Iron-Deficiency Anemia. Anemia. 2017;2017. (2) Medsafe M. Ferinject New Zealand Data Sheet. 2021; Available from: https://www.medsafe.govt.nz/profs/Datasheet/f/ferinjectinj.pdf
Locations(1)
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ACTRN12622001105730