Postpartum Anemia
Conditions
Brief summary
This study is aimed to compare the efficacy of two mode of iron administration to treat post partum anemia - a single dose of intravenous iron sucrose versus a single dose of iron sucrose and 6 weeks of treatment with oral iron supplement.
Detailed description
Anemia is common following delivery. It is associated with disturbing symptoms such as fatigue, cognitive impairment and syncope in severe cases. International guidelines recommend to use intravenous iron sucrose to treat intermediate and severe anemia until the target hemoglobin is achieved. However, patient's compliance after delivery is low, making the administration of several doses difficult. In those cases oral iron supplements might be used. In the present study the investigators will compare the efficacy of two iron administration protocols to treat post partum anemia - a single dose of intravenous iron sucrose versus a single dose of iron sucrose and 6 weeks of treatment with oral iron supplement.
Interventions
DIETARY_SUPPLEMENTIron sucrose 500 mg
DIETARY_SUPPLEMENTIron bisglycinate 60 mg
Sponsors
HaEmek Medical Center, Israel
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
* Women above 18 years old after giving birth * Women who suffer from iron deficiency anemia, defined as hemoglobin\< 9.5 g/dl without one of the conditions that are described in the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change between the hemoglobin level at randomization and the hemoglobin level after 6 weeks postpartum | After 6 weeks post partum |
Secondary
| Measure | Time frame |
|---|---|
| The composite symptoms of anemia and functional capacity after 6 weeks postpartum as assessed by a questionnaire | six weeks post partum |
| Type and rate of adverse events | Up to 6 weeks post partum |
| Women's satisfaction from the protocol treatment according to the VAS (visual analog scale) after 6 weeks post partum | Up to 6 weeks post partum |
| The change in hemoglobin level, ferritin, serum iron, transferrin, MCV and iron saturation from randomization to 6 weeks post partum | From randomization to 6 weeks post partum |
| The rate of women who will reach a target hemoglobin of at least 12 g/dl after 6 weeks of treatment | Six weeks post partum |
| The rate of patients who discontinued treatment | Up to 6 weeks post partum |
Countries
Israel
Outcome results
None listed