Anemia, Iron Deficiency, Pregnancy Related
Conditions
Brief summary
Evaluate the extent to which treatment of iron deficiency anemia beyond 24-34 weeks' gestation of pregnancy with intravenous iron increases hemoglobin compared to oral iron. The investigators will test the hypothesis that pregnant women who are anemic in the second and third trimester are more likely to significantly increase their hemoglobin with intravenous iron as opposed to the usual standard of care, oral iron.
Interventions
DRUGFerumoxytol Injection [Feraheme]
510mg intravenous ferumoxytol
DRUGFerrous Sulfate
325mg oral ferrous sulfate
Sponsors
Stanford University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Pregnant women 18 years old and above 2. Hemoglobin \< 11 g/dL, serum ferritin \< 30 ug/dL and or transferrin saturation (TSAT) \< 20% 3. Between 24-34 weeks' pregnancy 4. Singleton pregnancy 5. Receiving prenatal care at Stanford/LPCH OB clinic and planning to deliver at LPCH 6. Hemodynamically stable
Exclusion criteria
1. Patients unable to give informed consent 2. Known allergy/hypersensitivity to IV iron 3. Inflammatory Bowel Disease or history of gastric bypass surgery 4. Dialysis-dependent Chronic Kidney Disease/ ESRD 5. Known Hemoglobinopathies such as sickle cell disease, beta-thalassemia, alpha thalassemia 6. Folate/Vitamin B12 deficiency 7. Known malignancy 8. Medication allergy to Tylenol (acetaminophen) 9. Hemoglobin above 12 or less than 7 g/dL 10. Patients with complex past medical histories which may include history of multiple medication allergies (greater than 2 allergies), connective tissue disorder, etc. 11. Diagnosis of placenta previa
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Change in Hemoglobin Value Before and After Intervention | From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment) | Hemoglobin is measured as g/dL at enrollment and after the study intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Discontinued Treatment | From enrollment to delivery or birth admission (average approximately 8 to 12 weeks) | — |
| Number of Participants With Serious Adverse Events Associated With Treatment | From enrollment to delivery or birth admission (average approximately 8 to 12 weeks) | — |
| Number of Participants Who Need Blood Transfusion Postpartum | From enrollment to delivery or birth admission (average approximately 8 to 12 weeks) | — |
| Change in Short Form (SF-)36 General Health Symptom Score | From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment) | Score range: 0 to 100 (lower scores indicate more severe symptoms, higher scores correspond to fewer symptoms) |
| Change in Short Form (SF-)36 Physical Functioning Score | From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment) | Score range: 0 to 100 (lower scores indicate less physical function, higher scores correspond to more physical function). |
| Change in Short Form (SF-)36 Role Limitations Due to Physical Health Score | From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment) | Score range: 0 to 100 (lower scores indicate more limitations, higher scores correspond to fewer limitations). |
| Change in Short Form (SF-)36 Energy/Fatigue Score | From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment) | Score range: 0 to 100 (lower scores indicate more fatigue, higher scores correspond to more energy). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDeirdre Lyell
Stanford University
PRINCIPAL_INVESTIGATORIrogue Igbinosa, MD
Stanford University
Participant flow
Recruitment details
Can describe study design here, up to 500 characters with spaces
Pre-assignment details
83 participants signed informed consent; 80 were allocated to treatment.
Participants by arm
| Arm | Count |
|---|---|
| Oral Iron Participants are prescribed 1-2 ferrous sulfate 325mg tablets by mouth (based on severity of anemia) until delivery. | 40 |
| Intravenous Iron Participants receive 510mg intravenous iron ferumoxytol, with a maximum of 2 doses based on the baseline hemoglobin level. | 40 |
| Total | 80 |
Baseline characteristics
| Characteristic | Oral Iron | Intravenous Iron | Total |
|---|---|---|---|
| Age, Continuous | 34.0 years | 32.0 years | 32.0 years |
| Hemoglobin | 10.30 g/dL | 10.35 g/dL | 10.30 g/dL |
| Race/Ethnicity, Customized Hispanic/Latine | 11 Participants | 11 Participants | 22 Participants |
| Race/Ethnicity, Customized Non Hispanic Asian or Pacific Islander | 11 Participants | 12 Participants | 23 Participants |
| Race/Ethnicity, Customized Non Hispanic Black or African American | 2 Participants | 4 Participants | 6 Participants |
| Race/Ethnicity, Customized Non Hispanic White | 12 Participants | 12 Participants | 24 Participants |
| Race/Ethnicity, Customized Other/Unknown | 4 Participants | 1 Participants | 5 Participants |
| Region of Enrollment United States | 40 Participants | 40 Participants | 80 Participants |
| Sex: Female, Male Female | 40 Participants | 40 Participants | 80 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 17 / 40 | 15 / 40 | 13 / 40 | 9 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 | 0 / 40 | 0 / 40 |
Outcome results
Primary
Median Change in Hemoglobin Value Before and After Intervention
Hemoglobin is measured as g/dL at enrollment and after the study intervention
Time frame: From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment)
Population: Participants analyzable for the primary outcome (had data through week 4)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Oral Iron | Median Change in Hemoglobin Value Before and After Intervention | 10.95 g/dL |
| Intravenous Iron | Median Change in Hemoglobin Value Before and After Intervention | 11.45 g/dL |
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Change in Short Form (SF-)36 Energy/Fatigue Score
Score range: 0 to 100 (lower scores indicate more fatigue, higher scores correspond to more energy).
Time frame: From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment)
Population: Participants with data at the respective time point
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Oral Iron | Change in Short Form (SF-)36 Energy/Fatigue Score | Baseline | 50 score on a scale |
| Oral Iron | Change in Short Form (SF-)36 Energy/Fatigue Score | Change at week 4 | 0 score on a scale |
| Intravenous Iron | Change in Short Form (SF-)36 Energy/Fatigue Score | Baseline | 40 score on a scale |
| Intravenous Iron | Change in Short Form (SF-)36 Energy/Fatigue Score | Change at week 4 | 10 score on a scale |
Comparison: Between-group analysis of change at week 4p-value: 0.009Wilcoxon (Mann-Whitney)
Secondary
Change in Short Form (SF-)36 General Health Symptom Score
Score range: 0 to 100 (lower scores indicate more severe symptoms, higher scores correspond to fewer symptoms)
Time frame: From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment)
Population: Participants with data at the respective time point
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Oral Iron | Change in Short Form (SF-)36 General Health Symptom Score | Baseline | 63 score on a scale |
| Oral Iron | Change in Short Form (SF-)36 General Health Symptom Score | Change at week 4 | 0 score on a scale |
| Intravenous Iron | Change in Short Form (SF-)36 General Health Symptom Score | Baseline | 63 score on a scale |
| Intravenous Iron | Change in Short Form (SF-)36 General Health Symptom Score | Change at week 4 | 0 score on a scale |
Comparison: Between-group analysis of change at week 4p-value: 0.88Wilcoxon (Mann-Whitney)
Secondary
Change in Short Form (SF-)36 Physical Functioning Score
Score range: 0 to 100 (lower scores indicate less physical function, higher scores correspond to more physical function).
Time frame: From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment)
Population: Participants with data at the respective time point
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Oral Iron | Change in Short Form (SF-)36 Physical Functioning Score | Baseline | 70 score on a scale |
| Oral Iron | Change in Short Form (SF-)36 Physical Functioning Score | Change at week 4 | -10 score on a scale |
| Intravenous Iron | Change in Short Form (SF-)36 Physical Functioning Score | Baseline | 70 score on a scale |
| Intravenous Iron | Change in Short Form (SF-)36 Physical Functioning Score | Change at week 4 | 0 score on a scale |
Comparison: Between-group analysis of change at week 4p-value: 0.27Wilcoxon (Mann-Whitney)
Secondary
Change in Short Form (SF-)36 Role Limitations Due to Physical Health Score
Score range: 0 to 100 (lower scores indicate more limitations, higher scores correspond to fewer limitations).
Time frame: From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment)
Population: Participants with data at the respective time point
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Oral Iron | Change in Short Form (SF-)36 Role Limitations Due to Physical Health Score | Baseline | 38 score on a scale |
| Oral Iron | Change in Short Form (SF-)36 Role Limitations Due to Physical Health Score | Change at week 4 | 0 score on a scale |
| Intravenous Iron | Change in Short Form (SF-)36 Role Limitations Due to Physical Health Score | Change at week 4 | 0 score on a scale |
| Intravenous Iron | Change in Short Form (SF-)36 Role Limitations Due to Physical Health Score | Baseline | 50 score on a scale |
Comparison: Between-group analysis of change at week 4p-value: 0.72Wilcoxon (Mann-Whitney)
Secondary
Number of Participants Who Discontinued Treatment
Time frame: From enrollment to delivery or birth admission (average approximately 8 to 12 weeks)
Population: Intention to treat; all participants were analyzed according to the group to which they were randomized, regardless of treatment received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oral Iron | Number of Participants Who Discontinued Treatment | 6 Participants |
| Intravenous Iron | Number of Participants Who Discontinued Treatment | 1 Participants |
Secondary
Number of Participants Who Need Blood Transfusion Postpartum
Time frame: From enrollment to delivery or birth admission (average approximately 8 to 12 weeks)
Population: Intention to treat; all participants were analyzed according to the group to which they were randomized, regardless of treatment received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oral Iron | Number of Participants Who Need Blood Transfusion Postpartum | 3 Participants |
| Intravenous Iron | Number of Participants Who Need Blood Transfusion Postpartum | 0 Participants |
Secondary
Number of Participants With Serious Adverse Events Associated With Treatment
Time frame: From enrollment to delivery or birth admission (average approximately 8 to 12 weeks)
Population: Intention to treat; all participants were analyzed according to the group to which they were randomized, regardless of treatment received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oral Iron | Number of Participants With Serious Adverse Events Associated With Treatment | 0 Participants |
| Intravenous Iron | Number of Participants With Serious Adverse Events Associated With Treatment | 0 Participants |