Comparison of Oral Ferrous Sulfate to Intravenous Ferumoxytol in Antepartum Iron Deficiency Anemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 2
- 主要终点
- Median Change in Hemoglobin Value Before and After Intervention
研究概览
简要总结
Evaluate the extent to which treatment of iron deficiency anemia beyond 24-34 weeks' gestation of pregnancy with intravenous iron increases hemoglobin compared to oral iron. The investigators will test the hypothesis that pregnant women who are anemic in the second and third trimester are more likely to significantly increase their hemoglobin with intravenous iron as opposed to the usual standard of care, oral iron.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women 18 years old and above
- •Hemoglobin < 11 g/dL, serum ferritin < 30 ug/dL and or transferrin saturation (TSAT) < 20%
- •Between 24-34 weeks' pregnancy
- •Singleton pregnancy
- •Receiving prenatal care at Stanford/LPCH OB clinic and planning to deliver at LPCH
- •Hemodynamically stable
排除标准
- •Patients unable to give informed consent
- •Known allergy/hypersensitivity to IV iron
- •Inflammatory Bowel Disease or history of gastric bypass surgery
- •Dialysis-dependent Chronic Kidney Disease/ ESRD
- •Known Hemoglobinopathies such as sickle cell disease, beta-thalassemia, alpha thalassemia
- •Folate/Vitamin B12 deficiency
- •Known malignancy
- •Medication allergy to Tylenol (acetaminophen)
- •Hemoglobin above 12 or less than 7 g/dL
- •Patients with complex past medical histories which may include history of multiple medication allergies (greater than 2 allergies), connective tissue disorder, etc.
- •Diagnosis of placenta previa
研究组 & 干预措施
Intravenous iron
Participants will receive 510mg intravenous iron ferumoxytol, with a maximum of 2 doses based on the baseline hemoglobin level. The ferumoxytol is administered as an infusion for approximately 15 - 30 minutes.
干预措施: Ferumoxytol Injection [Feraheme] (Drug)
Oral iron
Participants will be prescribed 1-2 ferrous sulfate 325mg tablets by mouth (based on severity of anemia) until delivery. For standardization, the dosage is as follows based on severity: one ferrous sulfate tablet for women with baseline hemoglobin 9-11, and two ferrous sulfate tablets for hemoglobin < 9.
干预措施: Ferrous Sulfate (Drug)
结局指标
主要结局
Median Change in Hemoglobin Value Before and After Intervention
时间窗: From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment)
Hemoglobin is measured as g/dL at enrollment and after the study intervention
次要结局
- Number of Participants Who Discontinued Treatment(From enrollment to delivery or birth admission (average approximately 8 to 12 weeks))
- Number of Participants With Serious Adverse Events Associated With Treatment(From enrollment to delivery or birth admission (average approximately 8 to 12 weeks))
- Number of Participants Who Need Blood Transfusion Postpartum(From enrollment to delivery or birth admission (average approximately 8 to 12 weeks))
- Change in Short Form (SF-)36 General Health Symptom Score(From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment))
- Change in Short Form (SF-)36 Physical Functioning Score(From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment))
- Change in Short Form (SF-)36 Role Limitations Due to Physical Health Score(From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment))
- Change in Short Form (SF-)36 Energy/Fatigue Score(From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment))
研究者
Deirdre Lyell
Professor, Obstetrics & Gynecology
Stanford University