Early Antenatal Support for Iron Deficiency Anemia: A Randomized Controlled Trial of Early Initiation of Intravenous Versus Oral Iron Therapy for Treatment of Iron Deficiency Anemia in Pregnancy
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Hemoglobin
研究概览
简要总结
This is a randomized, controlled multi-site trial of iron therapy in pregnancy. The purpose of this research is to see if second trimester initiation of intravenous (IV) iron therapy is better than oral iron therapy for treatment of anemia in pregnancy by improving blood count, quality of life and reducing side effects.
详细描述
Pregnant singletons diagnosed with iron deficiency anemia will be enrolled between 14-24 weeks and will be randomized 1:1 to either a course of ferumoxytol (510mg x 2 doses 3-8 days apart) or oral iron (325mg) twice daily.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Singleton gestation
- •Gestational age <24 weeks
- •Baseline Hb ≥9.0 and <11.0 with evidence of iron deficiency anemia
- •Iron deficiency anemia diagnosed (at any point in patient history) by:
- •Ferritin<30 and/or total iron saturation <20
排除标准
- •Sickle cell Disease (NOT sickle cell trait)
- •Evidence of acute anemia requiring transfusion or IV iron therapy
- •Major congenital or chromosomal anomaly
- •Previous use of IV iron in this pregnancy
- •Severe cardiac, renal, or liver disease
- •Autoimmune disease (ie Systemic Lupus Erythematosus (SLE)
- •Allergy or contraindication to either study drug
- •History of medication allergy, reaction to IV infusion, or reaction to Feraheme or other IV iron products
研究组 & 干预措施
Oral Iron
325mg oral iron (ferrous sulfate) twice daily
干预措施: Ferrous Sulfate (Drug)
Intravenous Iron
510mg ferumoxytol intravenous infusion for two doses total; second dose 3-8 days after first dose.
干预措施: Ferumoxytol (Drug)
结局指标
主要结局
Change in Hemoglobin
时间窗: 90 days
Change in hemoglboin at day 90 following treatment initiation
次要结局
- Anemia resolution(90 days)
- Quality of life scale(30, 60, 90 days)
- Adherence(90 days)
- Anemia at Delivery(9 months)
- Need for post partum transfusion(9 months)
- Neonatal outcomes: cord blood iron indices(9 months)
- Need for additional therapy(9 months)
- Neonatal outcomes: birth weight(9 months)
- Neonatal outcomes gestational age of delivery (weeks)(9 months)