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Intravenous Versus Oral Iron in Late Pregnancy: Results of Treatment (EIVF)

Primary Purpose

Anemia, Pregnancy Complications

Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Ferli-6® (Continental Pharm co., ltd.)
Venofer® (Vifor AG, St. Gallen, Switzerland)
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia focused on measuring iron deficiency anemia, pregnancy, third trimester, intravenous iron, efficacy, a randomized trial, Female, Ferric Compounds/therapeutic use*, Infusions, Intravenous, Hematologic/therapy*

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Age 18-45 years old
  2. Singleton pregnancy at 32 weeks gestation
  3. Having anemia in the third trimester according to World Health Organization, namely, with a hemoglobin level of < 11 g/dL or hematocrit of < 33%
  4. Having no underlying disease such as hypertension, gestational diabetes mellitus, heart disease, peptic ulcer, etc.
  5. Having no history of allergy to iron containing medication
  6. Having no history or other allergic conditions or asthma
  7. Having no thalassemia disease, for examples: B thalassemia major, hemoglobin E/ B thalassemia, homozygous hemoglobin E, Hemoglobin H, AE Bart disease, and EF Bart disease. Pregnant women who have iron deficiency anemia and are thalassemia carriers such as A-thalassemia 1, B-thalassemia, or less severe Hb E/ B thalassemia are able to enter the study.
  8. Having no history of bleeding tendency
  9. Having no history of blood transfusion within the prior 120 days
  10. Having no history of delivery before 36 weeks gestation
  11. Giving consent and having signed the consent form for this study

Exclusion Criteria:

  1. Stool exam revealed parasitic infestation
  2. C-reactive protein > 3 mg/L
  3. Serum ferritin > 15 mcg/L

Sites / Locations

  • Siriraj Hospital, Mahidol University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Ferrous fumarate, Ferri-6®, Oral tablet

iron sucrose, Venofer®, intravenous drug

Arm Description

In the O-group, women had to take 3 ferrous fumarate tablets (Ferli-6®) everyday with a total of 200 mg of elemental iron per day from 33 weeks gestation until delivery. Emphasizing and monitoring for compliance to the treatment protocol were carried out.

Women in the IV-group received 500 mg iron sucrose (Venofer®, Vifor International AG, St. Gallen, Switzerland) divided into three weekly administrations. Two doses of 200 mg iron sucrose were given at 33 and 34 weeks gestation while the remaining (100 mg) was infused at gestation of 35 weeks. Thereafter, women in this group received no further iron therapy until delivery. In preparation, 200 mg of iron sucrose was diluted into 100 ml of 0.9% saline solution.

Outcomes

Primary Outcome Measures

Serum Ferritin Level

Secondary Outcome Measures

Haemoglobin Level

Full Information

First Posted
September 2, 2008
Last Updated
February 11, 2015
Sponsor
Mahidol University
Collaborators
Vifor Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00746551
Brief Title
Intravenous Versus Oral Iron in Late Pregnancy: Results of Treatment
Acronym
EIVF
Official Title
Low Dose Intravenous Versus Oral Iron for Iron Deficiency Anemia Starting Late in Pregnancy: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University
Collaborators
Vifor Pharma

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to compare the efficacy of body iron storage replenishment between low dose intravenous iron and oral iron in late pregnancy.
Detailed Description
Despite routine antenatal oral iron supplementation, the prevalence of iron deficiency anemia (IDA) in the 3rd trimester of pregnancy in developing countries remains high. Apparently, intravenous iron sucrose appears to be safe and efficient in treating within a short period. From literature review, no study of intravenous iron for IDA treatment has been carried out in the third trimester of pregnancy. This research aims to compare the efficacy of body iron storage replenishment at 3 weeks as labor may take place at this point in some women. In this study,500 mg intravenous iron has been given weekly instead of every other day for the sake of patient's convenience in the hope that parenteral iron may become another alternative for treatment of pregnant women with iron deficiency anemia who have difficulties or failures with oral iron.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Pregnancy Complications
Keywords
iron deficiency anemia, pregnancy, third trimester, intravenous iron, efficacy, a randomized trial, Female, Ferric Compounds/therapeutic use*, Infusions, Intravenous, Hematologic/therapy*

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ferrous fumarate, Ferri-6®, Oral tablet
Arm Type
Active Comparator
Arm Description
In the O-group, women had to take 3 ferrous fumarate tablets (Ferli-6®) everyday with a total of 200 mg of elemental iron per day from 33 weeks gestation until delivery. Emphasizing and monitoring for compliance to the treatment protocol were carried out.
Arm Title
iron sucrose, Venofer®, intravenous drug
Arm Type
Experimental
Arm Description
Women in the IV-group received 500 mg iron sucrose (Venofer®, Vifor International AG, St. Gallen, Switzerland) divided into three weekly administrations. Two doses of 200 mg iron sucrose were given at 33 and 34 weeks gestation while the remaining (100 mg) was infused at gestation of 35 weeks. Thereafter, women in this group received no further iron therapy until delivery. In preparation, 200 mg of iron sucrose was diluted into 100 ml of 0.9% saline solution.
Intervention Type
Drug
Intervention Name(s)
Ferli-6® (Continental Pharm co., ltd.)
Intervention Description
In the O-group, women had to take 3 ferrous fumarate tablets (Ferli-6®) everyday with a total of 200 mg of elemental iron per day from 33 weeks gestation until delivery. Emphasizing and monitoring for compliance to the treatment protocol were carried out.
Intervention Type
Drug
Intervention Name(s)
Venofer® (Vifor AG, St. Gallen, Switzerland)
Intervention Description
Women in the IV-group received 500 mg iron sucrose (Venofer®, Vifor International AG, St. Gallen, Switzerland) divided into three weekly administrations. Two doses of 200 mg iron sucrose were given at 33 and 34 weeks gestation while the remaining (100 mg) was infused at gestation of 35 weeks. Thereafter, women in this group received no further iron therapy until delivery. In preparation, 200 mg of iron sucrose was diluted into 100 ml of 0.9% saline solution.
Primary Outcome Measure Information:
Title
Serum Ferritin Level
Time Frame
3 weeks after intervention
Secondary Outcome Measure Information:
Title
Haemoglobin Level
Time Frame
3 weeks after intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18-45 years old Singleton pregnancy at 32 weeks gestation Having anemia in the third trimester according to World Health Organization, namely, with a hemoglobin level of < 11 g/dL or hematocrit of < 33% Having no underlying disease such as hypertension, gestational diabetes mellitus, heart disease, peptic ulcer, etc. Having no history of allergy to iron containing medication Having no history or other allergic conditions or asthma Having no thalassemia disease, for examples: B thalassemia major, hemoglobin E/ B thalassemia, homozygous hemoglobin E, Hemoglobin H, AE Bart disease, and EF Bart disease. Pregnant women who have iron deficiency anemia and are thalassemia carriers such as A-thalassemia 1, B-thalassemia, or less severe Hb E/ B thalassemia are able to enter the study. Having no history of bleeding tendency Having no history of blood transfusion within the prior 120 days Having no history of delivery before 36 weeks gestation Giving consent and having signed the consent form for this study Exclusion Criteria: Stool exam revealed parasitic infestation C-reactive protein > 3 mg/L Serum ferritin > 15 mcg/L
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pornpimol Ruangvutilert, MD, PhD.
Organizational Affiliation
Obstetrics and Gynecology Department, Faculty of Medicine Siriraj Hosptial, Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Siriraj Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

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Intravenous Versus Oral Iron in Late Pregnancy: Results of Treatment

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