Department of Obstetrics and Gynaecology, Westmead Hospital, Westmead, NSW, 2145, Australia.
Department of Medicine and Public Health, University of Sydney, Camperdown, NSW, 2050, Australia.
BMC Pregnancy Childbirth. 2017 Dec 19;17(1):424. doi: 10.1186/s12884-017-1596-x.
Acute post-partum anaemia can be associated with significant morbidity including a predisposition for postnatal depression. Lack of clear practice guidelines means a number of women are treated with multiple blood transfusions. Intravenous iron has the potential to limit the need for multiple blood transfusions but its role in the post-partum setting is unclear.
METHODS/DESIGN: IIBAPPA is a multi-centre randomised non-inferiority trial. Women with a primary post-partum haemorrhage (PPH) >1000 mL and resultant haemoglobin (Hb) 5.5-8.0 g/dL after resuscitation with ongoing symptomatic anaemia who are otherwise stable (no active bleeding) are eligible to participate. Patients with sepsis or conditions necessitating rapid Hb restoration are excluded. Eligible participants are randomised to receive a blood transfusion or a single dose of intravenous iron polymaltose calculated using the Ganzoni formula. Primary outcome measures include Hb, Ferritin and C-Reactive Protein levels on Day 7. Secondary outcomes evaluate (i) Hb, Ferritin and CRP levels on Day 14, 28, (ii) anaemia symptoms on Day 0, 7, 14 and 28 using structured health related quality of life questionnaires, (iii) treatment safety by assessing adverse reactions and infection endpoints and (iv) the quantitative impact of anaemia on breast feeding quality using a hospital designed questionnaire.
If equivalence in Hb and ferritin levels, symptom scores and safety endpoints is demonstrated, intravenous iron may become the preferred treatment for women with acute post-partum anaemia to minimise transfusion reactions and costs.
Australian and New Zealand Clinical Trials Registry: ACTRN12615001370594 on 16th December, 2015 (prospective approval).
产后急性贫血可能与显著的发病率相关，包括产后抑郁的倾向。缺乏明确的实践指南意味着许多妇女需要接受多次输血治疗。静脉铁剂有可能限制多次输血的需求，但它在产后环境中的作用尚不清楚。
方法/设计：IIBAPPA 是一项多中心随机非劣效性试验。在复苏后血红蛋白（Hb）为 5.5-8.0 g/dL 且仍有持续症状性贫血但无活动性出血的产妇中，发生产后大出血（PPH）>1000 mL 时，符合纳入标准。患有败血症或需要快速恢复 Hb 的情况的患者被排除在外。符合条件的患者随机接受输血或单次剂量的静脉铁多麦芽糖根据 Ganzoni 公式计算。主要观察指标包括第 7 天的 Hb、铁蛋白和 C 反应蛋白水平。次要结局评估包括：（i）第 14、28 天的 Hb、铁蛋白和 CRP 水平，（ii）第 0、7、14 和 28 天的贫血症状使用结构化健康相关生活质量问卷，（iii）通过评估不良反应和感染终点来评估治疗安全性，（iv）使用医院设计的问卷评估贫血对母乳喂养质量的定量影响。
如果在 Hb 和铁蛋白水平、症状评分和安全性终点方面证明等效，静脉铁可能成为治疗产后急性贫血的首选治疗方法，以最大限度地减少输血反应和成本。
澳大利亚和新西兰临床试验注册：ACTRN12615001370594，于 2015 年 12 月 16 日（前瞻性批准）。
