Once Versus Twice Daily Iron Supplementation in Pregnant Women

Anemia in Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02839096
• Other study ID #: 2004638
• Status: Recruiting
• Phase: N/A
• Start date: June 2016
• Est. completion date: December 2019

Study information

• Verified date: April 2019
• Source: University of Missouri-Columbia
• Contact: Daniel Jackson
• Phone: 5734996041
• Email: jacksondl[@]health.missouri.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Anemia in Pregnancy

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	University of Missouri	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Incidence of blood transfusion at delivery	The number of units of blood product transfused during the admission for delivery will be recorded	At delivery