Once Daily Versus Twice Daily Iron Supplementation to Treat Anemia in Pregnancy: A Prospective, Randomized, Placebo Controlled, Double Blinded, Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Hemoglobin
研究概览
简要总结
The investigators will randomize women diagnosed with anemia in the mid-trimester of pregnancy to once or twice daily iron supplementation
详细描述
Women defined as having iron deficiency anemia based on a low hemoglobin as defined by the American College of Obstetrics and Gynecology and a low serum ferritin, in the absence of hemoglobinopathy, will be randomized to ferrous sulfate 325mg PO daily or PO 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singleton gestation
- •Iron deficiency anemia as defined by a Hgb of less than 11mg/dL in the first and 3rd trimester and 10.5mg/dL in the 2nd trimester and a serum ferritin of less than 15ug/mL.
- •In accordance with American College of Obstetricians and Gynecologists (ACOG) guidelines, the Hgb cutoff will be reduced by 0.8mg/dL in African American women.
- •In accordance with the standard of care, African American women and those with a mean corpuscular volume (MCV) on their routine screening complete blood count (CBC) of less than 70 will require a hemoglobin electrophoresis to exclude hemoglobinopathy prior to enrollment.
排除标准
- •Multiple gestation
- •Maternal hemoglobinopathy or hemochromatosis,
- •Irritable bowel disease or irritable bowel syndrome
- •History of bariatric surgery or extensive bowel surgery
- •Individuals already receiving iron supplementation aside from prenatal vitamins.
研究组 & 干预措施
Once Daily Dosing
Randomized to 325mg of ferrous sulfate in the morning and placebo in the evening
干预措施: Placebo (Drug)
Once Daily Dosing
Randomized to 325mg of ferrous sulfate in the morning and placebo in the evening
干预措施: Ferrous Sulfate (Drug)
Twice Daily Dosing
Randomized to 325mg of ferrous sulfate in the morning and 325mg of ferrous sulfate in the evening
干预措施: Ferrous Sulfate (Drug)
结局指标
主要结局
Hemoglobin
时间窗: Change in hemoglobin from baseline to one day postpartum
Maternal Hemoglobin will be measured at baseline, at the time of admission for labor and delivery and on post partum day one. Postpartum day 1 hemoglobin was estimated from hematocrit by dividing by 2.941.
Incidence of Gastrointestinal Side Effects (i.e. Constipation, Upset Stomach) as Measured by a Validated Questionnaire
时间窗: From enrollment to delivery, which will be an average of 10-12 weeks
Record the incidence of gastrointestinal side effects (i.e. constipation, upset stomach) as measured by a validated questionnaire.
次要结局
- Incidence of Blood Transfusion at Delivery(At delivery)
研究者
Daniel Lee Jackson
Assistant Professor
University of Missouri-Columbia