A Comparison Between Intravenous Iron Sucrose to Its Combination With Oral Iron Supplements for the Treatment of Postpartum Anemia

HaEmek Medical Center, Israel

Status: Completed

Conditions: Postpartum Anemia

Treatments: Dietary Supplement: Iron bisglycinate 60 mg; Dietary Supplement: Iron sucrose 500 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT02458625

0133-14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 158 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 exclusion criteria

Exclusion criteria

• Women who suffer from known allergy for iron supplements
• Women who suffer from anemia not due to iron deficiency
• Women who suffer from acute infection
• Women who suffer from liver failure or viral hepatitis
• Women who suffer from thalassemia or hemoglobinopathies
• Women who suffer from renal failure
• Women who suffer from unbalanced thyroid disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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158 participants in 2 patient groups

Iron sucrose 500 mg

Active Comparator group

Description:

One treatment arm will receive a single dose of I.V iron sucrose 500 mg.

Treatment:

Dietary Supplement: Iron sucrose 500 mg

Iron sucrose 500 mg+60 mg Iron bisglycinate

Active Comparator group

Description:

Second treatment arm will receive a single dose of I.V iron sucrose 500 mg and oral treatment with 60 mg Iron bisglycinate for 6 weeks after giving birth.

Treatment:

Dietary Supplement: Iron bisglycinate 60 mg

Dietary Supplement: Iron sucrose 500 mg