Back to resultsOnce Versus Twice Daily Iron Supplementation in Pregnant Women
Primary Purpose
Anemia in Pregnancy
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Placebo
Ferrous Sulfate
Sponsored by
About this trial
This is an interventional treatment trial for Anemia in Pregnancy
Eligibility Criteria
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.
Sites / Locations
- University of MissouriRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Once Daily Dosing
Twice Daily Dosing
Arm Description
Randomized to 325mg of ferrous sulfate in the morning and placebo in the evening
Randomized to 325mg of ferrous sulfate in the morning and 325mg of ferrous sulfate in the evening
Outcomes
Primary Outcome Measures
Hemoglobin
Maternal Hemoglobin will be measured at baseline, at the time of admission for labor and delivery and on post partum day one
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
Secondary Outcome Measures
Incidence of blood transfusion at delivery
The number of units of blood product transfused during the admission for delivery will be recorded
Full Information
NCT ID
NCT02839096
First Posted
June 9, 2016
Last Updated
April 17, 2019
Sponsor
University of Missouri-Columbia
1. Study Identification
Unique Protocol Identification Number
NCT02839096
Brief Title
Once Versus Twice Daily Iron Supplementation in Pregnant Women
Official Title
Once Daily Versus Twice Daily Iron Supplementation to Treat Anemia in Pregnancy: A Prospective, Randomized, Placebo Controlled, Double Blinded, Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia in Pregnancy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Once Daily Dosing
Arm Type
Other
Arm Description
Randomized to 325mg of ferrous sulfate in the morning and placebo in the evening
Arm Title
Twice Daily Dosing
Arm Type
Other
Arm Description
Randomized to 325mg of ferrous sulfate in the morning and 325mg of ferrous sulfate in the evening
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Ferrous Sulfate
Intervention Description
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 Outcome Measure Information:
Title
Hemoglobin
Description
Maternal Hemoglobin will be measured at baseline, at the time of admission for labor and delivery and on post partum day one
Time Frame
Change in hemoglobin from baseline to one day postpartum
Title
Incidence of gastrointestinal side effects (i.e. constipation, upset stomach) as measured by a validated questionaire
Description
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 Outcome Measure Information:
Title
Incidence of blood transfusion at delivery
Description
The number of units of blood product transfused during the admission for delivery will be recorded
Time Frame
At delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Jackson
Phone
5734996041
Email
jacksondl@health.missouri.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth J Mosby, MS
Phone
573-817-3275
Email
mosbyej@health.missouri.edu
Facility Information:
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
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Once Versus Twice Daily Iron Supplementation in Pregnant Women
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