Once Versus Twice Daily Iron Supplementation in Pregnant Women

Study Overview
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Brief Summary
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The investigators will randomize women diagnosed with anemia in the mid-trimester of pregnancy to once or twice daily iron supplementation

Detailed Description
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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.

Official Title
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Once Daily Versus Twice Daily Iron Supplementation to Treat Anemia in Pregnancy: A Prospective, Randomized, Placebo Controlled, Double Blinded, Clinical Trial

Conditions
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Anemia in Pregnancy

Intervention / Treatment
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* Drug: Placebo
* Drug: Ferrous Sulfate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Once Daily Dosing<br>Randomized to 325mg of ferrous sulfate in the morning and placebo in the evening | Drug: Placebo<br>* Cellulose placebo that will be used in place of a second dose of ferrous sulfate in the subjects randomized to once daily dosing of ferrous sulfate<br>Drug: Ferrous Sulfate<br>* Subjects will receive once or twice daily dosing of ferrous sulfate. This will be provided by our hospital pharmacy and be identical in appearance to the placebo.<br>|
| Other: Twice Daily Dosing<br>Randomized to 325mg of ferrous sulfate in the morning and 325mg of ferrous sulfate in the evening | Drug: Ferrous Sulfate<br>* Subjects will receive once or twice daily dosing of ferrous sulfate. This will be provided by our hospital pharmacy and be identical in appearance to the placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin | Maternal Hemoglobin will be measured at baseline, at the time of admission for labor and delivery and on post partum day one | 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 | Gastrointestinal side effects (i.e. constipation, upset stomach) as measured by a validated questionaire | From enrollment to delivery, which will be an average of 10-12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of blood transfusion at delivery | The number of units of blood product transfused during the admission for delivery will be recorded | At delivery |