Once Versus Twice Daily Iron Supplementation in Pregnant Women
This trial is active, not recruiting.
|Condition||anemia in pregnancy|
|Treatments||placebo, ferrous sulfate|
|Sponsor||University of Missouri-Columbia|
|Start date||June 2016|
|End date||June 2017|
|Trial size||50 participants|
|Trial identifier||NCT02839096, 2004638|
The investigators will randomize women diagnosed with anemia in the mid-trimester of pregnancy to once or twice daily iron supplementation
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
time frame: Change in hemoglobin from baseline to one day postpartum
Incidence of gastrointestinal side effects (i.e. constipation, upset stomach) as measured by a validated questionaire
time frame: From enrollment to delivery, which will be an average of 10-12 weeks
Incidence of blood transfusion at delivery
time frame: At delivery
Female participants at least 18 years old.
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 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 an MCV on their routine screening 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.
|Official title||Once Daily Versus Twice Daily Iron Supplementation to Treat Anemia in Pregnancy: A Prospective, Randomized, Placebo Controlled, Double Blinded, Clinical Trial|
|Description||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.|
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