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

November 4, 2020 updated by: Zohar Nachum, HaEmek Medical Center, Israel
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

158

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Afula, Israel
        • Emek Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Iron sucrose 500 mg
One treatment arm will receive a single dose of I.V iron sucrose 500 mg.
Dietary supplement: Iron sucrose 500 mg
Active Comparator: Iron sucrose 500 mg+60 mg Iron bisglycinate
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.
Dietary supplement: Iron sucrose 500 mg
Dietary supplement: Iron bisglycinate 60 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The change between the hemoglobin level at randomization and the hemoglobin level after 6 weeks postpartum
Time Frame: After 6 weeks post partum
After 6 weeks post partum

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
six weeks post partum
Type and rate of adverse events
Time Frame: Up to 6 weeks post partum
Up to 6 weeks post partum
The rate of patients who discontinued treatment
Time Frame: Up to 6 weeks post partum
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
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
Six weeks post partum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HaEmek Medical Center, Israel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

June 7, 2020

Study Completion (Actual)

November 4, 2020

Study Registration Dates

First Submitted

May 28, 2015

First Submitted That Met QC Criteria

May 29, 2015

First Posted (Estimate)

June 1, 2015

Study Record Updates

Last Update Posted (Actual)

November 6, 2020

Last Update Submitted That Met QC Criteria

November 4, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0133-14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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