Anemia, Iron Deficiency, Delivery Complication
Conditions
Keywords
Postpartum, iron deficiency anemia, intravenous iron
Brief summary
This trial will be a comparative pragmatic open label feasibility randomized controlled trial of oral daily versus IV iron in anemic postpartum patients. Two randomly assigned groups will be compared during the postpartum period: 1. Oral Iron group: Ferrous sulfate 325 mg (65 mg elemental iron) by mouth for a total of 6 weeks TID. IV placebo in sodium chloride 0.9% 500mL IV infusion will be given before discharge home over 1 hour preceded by placebo test dose IV infusion of 100mL 0.9% sodium chloride. 2. IV Iron group: Low molecular weight iron dextran (infed) 1000mg in sodium chloride 0.9% 500mL IV infusion over 1 hour preceded by test dose 25 mg IV low molecular weight iron dextran infusion in 100mL 0.9% sodium chloride. 2.1 Oral placebo will be given by mouth for a total of 6 weeks TID.
Interventions
DRUGFerrous sulfate
one tablet 325 milligrams three times a day
DRUGIron dextran
1000 mg intravenous infusion
Sponsors
The University of Texas Medical Branch, Galveston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double blinded placebo controlled clinical trial. We will be using intravenous and oral placebos for each interventions
Intervention model description
Randomized control trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Delivery at our institution * Hemoglobin below 9 g/dl in postpartum day 1 * Singleton gestation
Exclusion criteria
* Diagnosis of malabsorptive disorder or history of gastric bypass procedure * Known diagnosis of anemia other than iron deficiency (thalassemia, macrocytic anemia, sickle cell, etc.) * Significant cardiovascular disease, including but not limited to myocardial infarction or unstable angina within 6 months prior to study inclusion or current history of NYHA Class III or IV congestive heart failure * Patient has received blood transfusion or there is a plan to transfuse * Lactose intolerance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin Level | 6 weeks after delivery | hemoglobin in grams per deciliters |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Nausea or Vomiting | up to 6 weeks after delivery | feeling sick to vomit or vomit |
| Myalgia | up to 6 weeks after delivery | Generalized muscle pain |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Oral Iron Group Ferrous sulfate 325 mg (65 mg elemental iron) by mouth for a total of 6 weeks three times daily.
Intravenous placebo in sodium chloride 0.9% 500mL IV infusion will be given before discharge home over 1 hour preceded by placebo test dose IV infusion of 100mL 0.9% sodium chloride.
Ferrous sulfate: one tablet 325 milligrams three times a day | 20 |
| IV Iron Group Low molecular weight iron dextran (infed) 1000mg in sodium chloride 0.9% 500mL IV infusion over 1 hour preceded by test dose 25 mg IV low molecular weight iron dextran infusion in 100mL 0.9% sodium chloride.
Oral placebo will be given by mouth for a total of 6 weeks TID.
Iron dextran: 1000 mg intravenous infusion | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 8 | 5 |
Baseline characteristics
| Characteristic | IV Iron Group | Total | Oral Iron Group |
|---|---|---|---|
| Age, Continuous | 31 years | 27 years | 24 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 20 participants | 40 participants | 20 participants |
| Sex: Female, Male Female | 20 Participants | 40 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 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Hemoglobin Level
hemoglobin in grams per deciliters
Time frame: 6 weeks after delivery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Oral Iron Group | Hemoglobin Level | 12 grams/deciliters |
| IV Iron Group | Hemoglobin Level | 12 grams/deciliters |
Secondary
Myalgia
Generalized muscle pain
Time frame: up to 6 weeks after delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oral Iron Group | Myalgia | 1 Participants |
| IV Iron Group | Myalgia | 0 Participants |
Secondary
Number of Participants With Nausea or Vomiting
feeling sick to vomit or vomit
Time frame: up to 6 weeks after delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oral Iron Group | Number of Participants With Nausea or Vomiting | 0 Participants |
| IV Iron Group | Number of Participants With Nausea or Vomiting | 0 Participants |