Lack of funds, PI left University

The investigators will randomize women diagnosed with anemia in the mid-trimester of 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.

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.

The final dataset will include (1) demographics, (2) baseline/postpartum hematocrit and levels of hemoglobin, ferritin and hepcidin, and (3) clinical data related to the pregnancy and outcomes. Protected personal information will be removed by trained staff at the Ob/Gyn Clinical Research Unit according to HIPAA guidelines. The final dataset will identify participants by a study number and dates will be replaced by time intervals. Data release is restricted to users under a data-transfer agreement (DTA) that provides for (1) a commitment to using the data only for research purposes and not to seek to identify any individual participant; (2) restrictions on redistribution of data to third parties, (3) a commitment to securing data using appropriate computer technology; and (4) a commitment to destroying or returning the data after analyses are completed. Upon DTA completion, access will be granted to a secured, cloud-based dataset monitored by the Information Technology Department.

Data will be available May 01, 2021 and will be available for 10 years from that date.

1. a commitment to using the data only for research purposes and not seek to identify any individual participant
2. restrictions on redistribution of the data to third parties
3. a commitment to securing the data using appropriate computer technology
4. a commitment to destroying or returning the data after analyses are completed
5. completion of a data-sharing agreement between the researcher requesting data and the University of Missouri

Data were collected between enrollment and delivery, approximately 12 weeks.

A questionnaire was administered to assess gastrointestinal symptoms. The incidence of one or more of nausea, hearburn, or abdominal pain is reported as a non-serious adverse event.

A sample size calculation predicted that 17 participants would be needed in each treatment arm. However, accrual was halted prematurely due to the move of the principal investigator to another institution. In total, 20 subjects were randomized in the study. The gastrointestinal symptom questionnaire was not completed by one subject and delivery data were not available for a separate subject, who did not deliver at the University of Missouri.

The Clinical Research Unit provides randomization order to the Investigational Pharmacy, which provides treatment or placebo tablets sets to the care provider.