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

HaEmek Medical Center, Israel158 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

158

Conditions

Postpartum Anemia

Interventions

Iron sucrose 500 mgDIETARY_SUPPLEMENT

Iron bisglycinate 60 mgDIETARY_SUPPLEMENT

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Emek Medical Center

Afula, Israel

Outcomes

Primary Outcomes

The change between the hemoglobin level at randomization and the hemoglobin level after 6 weeks postpartum

Time frame: After 6 weeks post partum

Secondary Outcomes

Women's satisfaction from the protocol treatment according to the VAS (visual analog scale) after 6 weeks post partum

Time frame: Up to 6 weeks post partum

The composite symptoms of anemia and functional capacity after 6 weeks postpartum as assessed by a questionnaire

Time frame: six weeks post partum

Type and rate of adverse events

Time frame: Up to 6 weeks post partum

The rate of patients who discontinued treatment

Time frame: 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

Time frame: 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

Time frame: Six weeks post partum

Data from ClinicalTrials.gov

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