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

Abstract

AbstractBackgroundEvidence for the management of moderate‐to‐severe postpartum anemia is limited. A randomized trial is needed; recruitment may be challenging.Study Design and MethodsRandomized 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. Primary outcome: number of recruits; proportion of those approached; proportion considered potentially eligible. Secondary outcomes: fatigue, depression, baby‐feeding, and hemoglobin at 1, 6 and 12 weeks; ferritin at 6 and 12 weeks. Surveys explored attitudes to trial participation.ResultsOver 16 weeks and three sites, 26/34 (76%) women approached consented to trial participation, including eight (31%) Māori 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).DiscussionWillingness 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.