Pregnancy
Conditions
Brief summary
This study is aimed to compare the efficacy of 2 doses of iron sucrose given intravenously - 200 mg versus 500 mg.
Detailed description
Anemia is common during pregnancy. It is associated with maternal and neonatal complications. It is acceptable to prescribe oral iron supplements. However, gastrointestinal side effects are very common and those lead to patient's intolerance as well as low patient's compliance. In those cases, as well as in severe anemia it is recommended to give iron sucrose. This drug is administered intravenously is effective to treat iron deficiency anemia with a minimal adverse effect profile. The two methods of giving iron sucrose is (1) to give I.V 200 mg iron sucrose 2-3 times/week or (2) to give I.V 500 mg iron sucrose once a week In the present study we aim to compare between the efficacy of those 2 protocols.
Interventions
DIETARY_SUPPLEMENTIron sucrose 200 mg
I.V Iron sucrose 200 mg 2-3 times per week. Each time for 20-30 minutes
DIETARY_SUPPLEMENTIron sucrose 500 mg
I.V Iron sucrose 500 mg once per week. Each time for 3.5 hours
Sponsors
HaEmek Medical Center, Israel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Singleton pregnancy * Iron deficiency anemia * Intolerance or low compliance for oral iron
Exclusion criteria
* Known allergy for iron supplements * Anemia not due to iron deficiency * Acute infection * Liver failure or viral hepatitis * Thalassemia or hemoglobinopathies * Asthma * Multiple pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change between the hemoglobin level at randomization and the hemoglobin level at the time of delivery | from randomization to delivery | Hemoglobin levels will be obtained at the beginning of the study and around delivery |
| Women's satisfaction from the protocol treatment according to the VAS (visual analog scale) | The day after delivery | — |
Secondary
| Measure | Time frame |
|---|---|
| The weekly change in hemoglobin level, ferritin, serum iron, transferrin, MCV, iron saturation and reticolocyte count from randomization | Up to 4 weeks |
| The change in hemoglobin level, ferritin, serum iron, transferrin, MCV, iron saturation and reticolocyte count from the last dose of iron sucrose to delivery in 3 weeks intervals | Up to 30 weeks |
| The need for blood transfusion post partum | up to 4 days post partum |
| Type and rate of adverse events | Up to 30 weeks |
| The rate of anemia associated symptoms | From randomization and up to 30 weeks |
| The levels of neonatal hemoglobin, ferritin and bilirubin | up to 4 days post partum |
| The rate of neonatal polycythemia and need for phototherapy | up to 4 days post partum |
| The need for iron sucrose administration post partum | up to 4 days post partum |
| The rate of patients who discontinued treatment | Up to 30 weeks |
Outcome results
None listed