Single Dose Intravenous Iron Isomaltoside in Combination With Oral Iron vs Oral Iron Monotherapy in Patients With Anemia After Postpartum Haemorrhage: A Single-blinded, Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Hemoglobin concentration (g/dL)
研究概览
简要总结
The investigator's study is going to compare effectiveness of single dose intravenous iron in combination with oral iron versus oral iron monotherapy in correcting haemoglobin deficit, replenishing iron stores and improving clinical symptoms in women with post-partum anaemia after postpartum hemorrhage without increasing the rate of adverse outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women who underwent spontaneous vaginal delivery with Post partum hemorrhage (PPH) ≥ 500ml OR women who underwent lower segment caesarean section with PPH ≥ 1000 ml
- •post PPH haemoglobin level ≤ 10.0 g/dl measured within 48hrs after delivery and stabilisation & resuscitation.
- •≥ 18 years of age
- •Proficient in Malaysian language or English language
- •Willingness to consent for blood taking and attending follow-up at 2 weeks and 6 weeks
排除标准
- •refused consent to participate in trial
- •history of hemolytic anemia, Thalassemia , and sickle cell anemia
- •women with signs of sepsis (clinical or laboratory evidence-intrapartum fever >38.5 degrees with abnormal vital signs, positive blood culture)
- •clinical or laboratory evidence of hepatic or renal, cardiovascular and hemolytic abnormalities
- •history of active severe acid peptic disorder, esophagitis or hiatus hernia and malabsorption syndrome.
- •Severe symptoms of anemia including dyspnoea at rest, angina pectoris, syncope or transient ischemic attacks.
- •history of severe asthma, eczema or other atopic allergy
- •known allergy to iron
- •patients with known immune or inflammatory conditions (e.g. systemic lupus erythematosus, rheumatoid arthritis).
研究组 & 干预措施
Intravenous Iron Group
干预措施: Iron Isomaltoside 1000 (Drug)
Intravenous Iron Group
干预措施: Iberet-Folic-500 (Drug)
Oral Iron Group
干预措施: Placebo (Drug)
Oral Iron Group
干预措施: Iberet-Folic-500 (Drug)
结局指标
主要结局
Hemoglobin concentration (g/dL)
时间窗: Six weeks after intervention
To evaluate the increase in hemoglobin level
Serum ferritin concentration
时间窗: six weeks after intervention
serum ferritin levels (µg/L)
Serum iron concentration
时间窗: Six weeks after intervention
To evaluate the increase in serum iron concentration (µmol/L)
次要结局
- Number of participants that had adverse effects to intravenous iron(Up to six weeks after intervention)
- Blood transfusion requirement(Up to six weeks after intervention)
- General fatigue score(Six weeks after intervention)
研究者
Dr Carolyn Yim Chue Wai
Consultant Anaesthesiologist
University of Malaya