Once Versus Twice Daily Iron Supplementation in Pregnant Women
- Registration Number
- NCT02839096
- Lead Sponsor
- University of Missouri-Columbia
- Brief Summary
The investigators will randomize women diagnosed with anemia in the mid-trimester of pregnancy to once or twice daily iron supplementation
- Detailed 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 50
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Once Daily Dosing Placebo Randomized to 325mg of ferrous sulfate in the morning and placebo in the evening Once Daily Dosing Ferrous Sulfate Randomized to 325mg of ferrous sulfate in the morning and placebo in the evening Twice Daily Dosing Ferrous Sulfate Randomized to 325mg of ferrous sulfate in the morning and 325mg of ferrous sulfate in the evening
- Primary Outcome Measures
Name Time Method Hemoglobin 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 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.
- Secondary Outcome Measures
Name Time Method Incidence of Blood Transfusion at Delivery At delivery The number of patients who received a blood product transfusion at delivery.
Trial Locations
- Locations (1)
University of Missouri
🇺🇸Columbia, Missouri, United States