Anemia in Pregnancy
Conditions
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.
Interventions
DRUGPlacebo
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
DRUGFerrous 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.
Sponsors
University of Missouri-Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The Clinical Research Unit provides randomization order to the Investigational Pharmacy, which provides treatment or placebo tablets sets to the care provider.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Blood Transfusion at Delivery | At delivery | The number of patients who received a blood product transfusion at delivery. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Once Daily Dosing 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. | 11 |
| Twice Daily Dosing 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. | 9 |
| Total | 20 |
Baseline characteristics
| Characteristic | Once Daily Dosing | Twice Daily Dosing | Total |
|---|---|---|---|
| Age, Continuous | 25.545 years STANDARD_DEVIATION 3.959 | 29.333 years STANDARD_DEVIATION 3.905 | 27.250 years STANDARD_DEVIATION 4.29 |
| Baseline Hematocrit | 30.790 percent STANDARD_DEVIATION 1.608 | 32.480 percent STANDARD_DEVIATION 2.688 | 31.590 percent STANDARD_DEVIATION 2.292 |
| Baseline Hemoglobin | 10.300 g/dL STANDARD_DEVIATION 0.645 | 11.000 g/dL STANDARD_DEVIATION 1.079 | 10.632 g/dL STANDARD_DEVIATION 0.924 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 10 Participants | 7 Participants | 17 Participants |
| Sex: Female, Male Female | 11 Participants | 9 Participants | 20 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 9 |
| other Total, other adverse events | 6 / 11 | 5 / 9 |
| serious Total, serious adverse events | 0 / 11 | 0 / 9 |
Outcome results
Primary
Hemoglobin
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.
Time frame: Change in hemoglobin from baseline to one day postpartum
Population: One participant delivered at another hospital and so baseline, but not delivery or postpartum hemoglobin measurements were obtained.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Once Daily Dosing | Hemoglobin | baseline hemoglobin | 10.264 g/dL |
| Once Daily Dosing | Hemoglobin | estimated postpartum hemoglobin | 10.105 g/dL |
| Once Daily Dosing | Hemoglobin | hemoglobin at delivery | 10.810 g/dL |
| Once Daily Dosing | Hemoglobin | change in hemoglobin from baseline to postpartum day 1 | -0.195 g/dL |
| Once Daily Dosing | Hemoglobin | change in hemoglobin from baseline to delivery | 0.51 g/dL |
| Twice Daily Dosing | Hemoglobin | change in hemoglobin from baseline to postpartum day 1 | -0.569 g/dL |
| Twice Daily Dosing | Hemoglobin | change in hemoglobin from baseline to delivery | 0.656 g/dL |
| Twice Daily Dosing | Hemoglobin | baseline hemoglobin | 11.000 g/dL |
| Twice Daily Dosing | Hemoglobin | hemoglobin at delivery | 11.656 g/dL |
| Twice Daily Dosing | Hemoglobin | estimated postpartum hemoglobin | 10.431 g/dL |
Primary
Incidence of Gastrointestinal Side Effects (i.e. Constipation, Upset Stomach) as Measured by a Validated Questionnaire
Record the incidence of gastrointestinal side effects (i.e. constipation, upset stomach) as measured by a validated questionnaire.
Time frame: From enrollment to delivery, which will be an average of 10-12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Once Daily Dosing | Incidence of Gastrointestinal Side Effects (i.e. Constipation, Upset Stomach) as Measured by a Validated Questionnaire | 1.900 symptoms |
| Twice Daily Dosing | Incidence of Gastrointestinal Side Effects (i.e. Constipation, Upset Stomach) as Measured by a Validated Questionnaire | 1.222 symptoms |
Secondary
Incidence of Blood Transfusion at Delivery
The number of patients who received a blood product transfusion at delivery.
Time frame: At delivery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Once Daily Dosing | Incidence of Blood Transfusion at Delivery | 1 participants |
| Twice Daily Dosing | Incidence of Blood Transfusion at Delivery | 0 participants |