The fatigue after infusion or transfusion pilot trial and feasibility study: A three-armed randomized pilot trial of intravenous iron and blood transfusion for the treatment of postpartum anemia.
Transfusion
; 64(2): 301-314, 2024 02.
Article
em En
| MEDLINE
| ID: mdl-38149691
ABSTRACT
BACKGROUND:
Evidence for the management of moderate-to-severe postpartum anemia is limited. A randomized trial is needed; recruitment may be challenging. STUDY DESIGN ANDMETHODS:
Randomized pilot trial with feasibility surveys. INCLUSION hemoglobin 65-79 g/L, ≤7 days of birth, hemodynamically stable. EXCLUSION ongoing heavy bleeding; already received, or contraindication to intravenous (IV)-iron or red blood cell transfusion (RBC-T). Intervention/control IV-iron; RBC-T; or IV-iron and RBC-T. PRIMARYOUTCOME:
number of recruits; proportion of those approached; proportion considered potentially eligible. SECONDARYOUTCOMES:
fatigue, depression, baby-feeding, and hemoglobin at 1, 6 and 12 weeks; ferritin at 6 and 12 weeks. Surveys explored attitudes to trial participation.RESULTS:
Over 16 weeks and three sites, 26/34 (76%) women approached consented to trial participation, including eight (31%) Maori women. Of those potentially eligible, 26/167 (15.6%) consented to participate. Key participation enablers were altruism and study relevance. For clinicians and stakeholders the availability of research assistance was the key barrier/enabler. Between-group rates of fatigue and depression were similar. Although underpowered to address secondary outcomes, IV-iron and RBC-T compared with RBC-T were associated with higher hemoglobin concentrations at 6 (mean difference [MD] 11.7 g/L, 95% confidence interval [CI] 2.7-20.7) and 12 (MD 12.8 g/L, 95% CI 1.5-24.2) weeks, and higher ferritin concentrations at 6 weeks (MD 136.8 mcg/L, 95% CI 76.6-196.9).DISCUSSION:
Willingness to participate supports feasibility for a future trial assessing the effectiveness of IV-iron and RBC-T for postpartum anemia. Dedicated research assistance will be critical to the success of an appropriately powered trial including women-centered outcomes.Palavras-chave
Texto completo:
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Base de dados:
MEDLINE
Assunto principal:
Transfusão de Eritrócitos
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Período Pós-Parto
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Hematínicos
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Anemia
Limite:
Female
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Humans
Idioma:
En
Ano de publicação:
2024
Tipo de documento:
Article