A Randomized Trial of Intermittent Oral Iron Supplementation vs. Daily Oral Iron Supplementation for the Treatment of Anemia in Pregnancy
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Difference in Hemoglobin Levels From Enrollment to End of Study
研究概览
简要总结
The target population for our study is pregnant women in the first or second trimester with a diagnosis of iron deficiency anemia. If a subject is eligible, written consent will be obtained by person to person contact. Eligible participants will be randomized to receive either daily oral iron supplementation or every other day oral iron supplementation.
详细描述
Eligible pregnant women in the first or second trimester who carry a diagnosis of iron deficiency anemia as defined by the American College of Obstetrics and Gynecology will be approached, consented, and randomized to receive either daily oral ferrous sulfate (325mg) supplementation or every other day oral ferrous sulfate (650mg). Participants will undergo a phone survey 2-4 weeks after starting the study to assess for side effects. Participants will continue routine care and surveillance of iron deficiency in pregnancy until the end of pregnancy.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Hemoglobin less than 11 g/dl in the first trimester or less than 10.5 g/dl in the second trimester
- •Microcytic anemia
- •Singleton gestation in the first or second trimester
排除标准
- •Malabsorptive disorder or history of restrictive or malabsorptive gastric surgery
- •Known diagnosis of anemia other than iron deficiency (thalassemia, macrocytic, sickle cell, etc.)
- •History of cardiopulmonary disease
- •Severe anemia requiring parental infusion or transfusion of blood products
研究组 & 干预措施
Daily iron supplementation
Oral ferrous sulfate, 325 mg, take once daily
干预措施: Ferrous sulfate (Drug)
Alternate day iron supplementation
Oral ferrous sulfated, 650mg, taken once daily every other day
干预措施: Ferrous sulfate (Drug)
结局指标
主要结局
Difference in Hemoglobin Levels From Enrollment to End of Study
时间窗: Baseline and again 8-9 months later (third trimester of pregnancy)
Hemoglobin levels will be assessed by blood draw upon enrollment and again in the third trimester of pregnancy
Change in Hematocrit in the Third Trimester After Treatment
时间窗: Baseline and again 8-9 months later (third trimester of pregnancy)
Hematocrit levels will be assessed by blood draw upon enrollment and again in the third trimester of pregnancy
次要结局
- Gastrointestinal Side Effects After 2-4 Weeks of Treatment(2-4 weeks after enrollment)
- Number of Participants Who Receive Intravenous (IV) Iron Supplementation(At completion of study, on average after 9 months)
- Postpartum Hematocrit(At completion of study, on average after 9 months)
- Neonatal Apgar Scores(At completion of study, on average after 9 months)
- Weight Class at Time of Enrollment(Baseline only at time of enrollment)
- Total Iron Binding Capacity at Time of Enrollment(Baseline only at time of enrollment)
- Number of Newborns Who Are Admitted to the Neonatal Intensive Care Unit (NICU).(At completion of study, on average after 9 months)
- Complete Blood Count in the Third Trimester(8-9 months after enrollment (third trimester of pregnancy))
- Serum Ferritin at Time of Enrollment(Baseline only at time of enrollment)
- Transferrin at Time of Enrollment(Baseline only at time of enrollment)
- Number of Participants Who Receive a Blood Transfusion(At completion of study, on average after 9 months)
- Level of Neonatal Bilirubin at Birth(At completion of study, on average after 9 months)
- Postpartum Hemoglobin(At completion of study, on average after 9 months)
- Neonatal Weight at Delivery(At completion of study, on average after 9 months)