Intravenous Versus Oral Iron in Late Pregnancy: Results of Treatment

NCT ID: NCT00746551

Last Updated: 2015-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2010-04-30

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.

Conditions

Anemia; Pregnancy Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Vifor Pharma

INDUSTRY

Sponsor Role: collaborator

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Pharuhas Chanprapaph

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pornpimol Ruangvutilert, MD, PhD.

Role: PRINCIPAL_INVESTIGATOR

Obstetrics and Gynecology Department, Faculty of Medicine Siriraj Hosptial, Mahidol University

Locations

Siriraj Hospital, Mahidol University

Bangkok, Bangkok, Thailand

Countries

Thailand

Other Identifiers

296/2551(EC3)

Identifier Type: -

Identifier Source: org_study_id