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

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

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.

Study Overview

• Status: Completed
• Conditions: Anemia; Pregnancy Complications
• Intervention / Treatment: Drug: Ferli-6® (Continental Pharm co., ltd.); Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10700
    • Siriraj Hospital, Mahidol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Serum Ferritin Level	3 weeks after intervention

Secondary Outcome Measures

Outcome Measure	Time Frame
Haemoglobin Level	3 weeks after intervention

Collaborators and Investigators

• Sponsor: Mahidol University
• Collaborators: Vifor Pharma
• Investigators: Principal Investigator: Pornpimol Ruangvutilert, MD, PhD., Obstetrics and Gynecology Department, Faculty of Medicine Siriraj Hosptial, Mahidol University

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: September 2, 2008
• First Submitted That Met QC Criteria: September 3, 2008
• First Posted (Estimate): September 4, 2008

Study Record Updates

• Last Update Posted (Estimate): February 16, 2015
• Last Update Submitted That Met QC Criteria: February 11, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: pregnancy; efficacy; Female; iron deficiency anemia; Infusions, Intravenous; intravenous iron; third trimester; a randomized trial; Ferric Compounds/therapeutic use*; Hematologic/therapy*
• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia; Pregnancy Complications; Hematinics; Ferric Oxide, Saccharated
• Other Study ID Numbers: 296/2551(EC3)