Once Versus Twice Daily Iron Supplementation in Pregnant Women
Status: | Recruiting |
---|---|
Conditions: | Anemia |
Therapuetic Areas: | Hematology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 9/7/2017 |
Start Date: | June 2016 |
End Date: | August 2018 |
Contact: | Daniel Jackson |
Email: | jacksondl@health.missouri.edu |
Phone: | 5734996041 |
Once Daily Versus Twice Daily Iron Supplementation to Treat Anemia in Pregnancy: A Prospective, Randomized, Placebo Controlled, Double Blinded, Clinical Trial
The investigators will randomize women diagnosed with anemia in the mid-trimester of
pregnancy to once or twice daily iron supplementation
pregnancy to once or twice daily iron supplementation
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.
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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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