Overview

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

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Other)
Randomized to 325mg of ferrous sulfate in the morning and placebo in the evening
placebo
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
ferrous sulfate
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.
(Other)
Randomized to 325mg of ferrous sulfate in the morning and 325mg of ferrous sulfate in the evening
ferrous sulfate
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.

Primary Outcomes

Measure
Hemoglobin
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

Secondary Outcomes

Measure
Incidence of blood transfusion at delivery
time frame: At delivery

Eligibility Criteria

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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by University of Missouri-Columbia.