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

This study has been completed.
Sponsor:
Collaborator:
Vifor Inc.
Information provided by (Responsible Party):
Pharuhas Chanprapaph, Mahidol University
ClinicalTrials.gov Identifier:
NCT00746551
First received: September 2, 2008
Last updated: November 30, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Anemia
Pregnancy Complications
Drug: Ferli-6® (Continental Pharm co., ltd.)
Drug: Venofer® (Vifor AG, St. Gallen, Switzerland)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Low Dose Intravenous Versus Oral Iron for Iron Deficiency Anemia Starting Late in Pregnancy: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • serum ferritin level [ Time Frame: 3 weeks after intervention ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • hemoglobin level [ Time Frame: 3 weeks after intervention ] [ Designated as safety issue: Yes ]

Enrollment: 80
Study Start Date: September 2008
Study Completion Date: April 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ferrous fumarate, Ferri-6®, Oral tablet
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.
Drug: Ferli-6® (Continental Pharm co., ltd.)
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.
Other Name: Ferli-6® (Continental Pharm co., ltd.)
Experimental: iron sucrose, Venofer®, intravenous drug
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.
Drug: Venofer® (Vifor AG, St. Gallen, Switzerland)
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.
Other Name: Venofer® (Vifor AG, St. Gallen, Switzerland)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00746551

Locations
Thailand
Siriraj Hospital, Mahidol University
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Vifor Inc.
Investigators
Principal Investigator: Pornpimol Ruangvutilert, MD, PhD. Obstetrics and Gynecology Department, Faculty of Medicine Siriraj Hosptial, Mahidol University
  More Information

No publications provided

Responsible Party: Pharuhas Chanprapaph, Associate Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT00746551     History of Changes
Other Study ID Numbers: 296/2551(EC3)
Study First Received: September 2, 2008
Last Updated: November 30, 2012
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
iron deficiency anemia
pregnancy
third trimester
intravenous iron
efficacy
a randomized trial
Female
Ferric Compounds/therapeutic use*
Infusions, Intravenous
Hematologic/therapy*

Additional relevant MeSH terms:
Anemia
Pregnancy Complications
Anemia, Iron-Deficiency
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Ferric oxide, saccharated
Ferrous fumarate
Iron
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 18, 2014