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Completed

NCT Number: NCT00746551

Intravenous Versus Oral Iron in Late Pregnancy: Results of Treatment

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.

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Key information

Conditions

Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ferli-6® (Continental Pharm co., ltd.)

Drug

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.

Venofer® (Vifor AG, St. Gallen, Switzerland)

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.

Primary outcomes

  1. Serum Ferritin Level

    Time frame: 3 weeks after intervention

Secondary outcomes

  1. Haemoglobin Level

    Time frame: 3 weeks after intervention

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Collaborators

  • Vifor Pharma

Registry information

Official study title

Low Dose Intravenous Versus Oral Iron for Iron Deficiency Anemia Starting Late in Pregnancy: A Randomized Controlled Trial

Acronym: EIVF

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Sep 4, 2008
Registry last updated
Feb 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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