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

Not Applicable

Completed

• Conditions: Postpartum Anemia
• Interventions: Dietary Supplement: Iron sucrose 500 mg; Dietary Supplement: Iron bisglycinate 60 mg

• Registration Number: NCT02458625
• Lead Sponsor: HaEmek Medical Center, Israel

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.

Study Timeline

• Study First Submitted: 2015-05-28
• Study First Submitted QC: 2015-05-29
• Study First Posted: 2015-06-01
• Study Start: 2016-04
• Primary Completion: 2020-06-07
• Status Verified: 2020-11
• Study Completion: 2020-11-04
• Last Update Submitted: 2020-11-04
• Last Update Posted: 2020-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 158

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Iron sucrose 500 mg+60 mg Iron bisglycinate	Iron sucrose 500 mg	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.
Iron sucrose 500 mg	Iron sucrose 500 mg	One treatment arm will receive a single dose of I.V iron sucrose 500 mg.
Iron sucrose 500 mg+60 mg Iron bisglycinate	Iron bisglycinate 60 mg	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.

Primary Outcome Measures

Name	Time	Method
The change between the hemoglobin level at randomization and the hemoglobin level after 6 weeks postpartum	After 6 weeks post partum

Secondary Outcome Measures

Name	Time	Method
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 rate of patients who discontinued treatment	Up to 6 weeks post partum
Type and rate of adverse events	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 composite symptoms of anemia and functional capacity after 6 weeks postpartum as assessed by a questionnaire	six weeks post partum

Trial Locations

Locations (1)

Emek Medical Center; 🇮🇱 Afula, Israel