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

Primary Purpose

Postpartum Anemia

Status

Completed

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Iron sucrose 500 mg

Iron bisglycinate 60 mg

About this trial

This is an interventional treatment trial for Postpartum Anemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

Emek Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Iron sucrose 500 mg

Iron sucrose 500 mg+60 mg Iron bisglycinate

Arm Description

One treatment arm will receive a single dose of I.V 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

Type and rate of adverse events

The rate of patients who discontinued treatment

The change in hemoglobin level, ferritin, serum iron, transferrin, MCV and iron saturation 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

Full Information

NCT ID

NCT02458625

First Posted

May 28, 2015

Last Updated

November 4, 2020

Sponsor

HaEmek Medical Center, Israel

1. Study Identification

Unique Protocol Identification Number

NCT02458625

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

April 2016 (Actual)

Primary Completion Date

June 7, 2020 (Actual)

Study Completion Date

November 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

HaEmek Medical Center, Israel

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postpartum Anemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

158 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Iron sucrose 500 mg

Arm Type

Active Comparator

Arm Description

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

Arm Title

Iron sucrose 500 mg+60 mg Iron bisglycinate

Arm Type

Active Comparator

Arm 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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Iron sucrose 500 mg

Intervention Type

Dietary Supplement

Intervention Name(s)

Iron bisglycinate 60 mg

Primary Outcome Measure Information:

Title

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

Time Frame

After 6 weeks post partum

Secondary Outcome Measure Information:

Title

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

Title

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

Time Frame

six weeks post partum

Title

Type and rate of adverse events

Time Frame

Up to 6 weeks post partum

Title

The rate of patients who discontinued treatment

Time Frame

Up to 6 weeks post partum

Title

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

Title

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Emek Medical Center

City

Afula

Country

Israel

12. IPD Sharing Statement

Citations:

PubMed Identifier

34171389

Citation

Yefet E, Mruat Rabah S, Sela ND, Hosary Mhamed S, Yossef A, Nachum Z. Addition of oral iron bisglycinate to intravenous iron sucrose for the treatment of postpartum anemia-randomized controlled trial. Am J Obstet Gynecol. 2021 Dec;225(6):668.e1-668.e9. doi: 10.1016/j.ajog.2021.06.069. Epub 2021 Jun 23.

Results Reference

derived

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

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