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

Mahidol University

Status and phase: Completed; Phase 4

Conditions: Anemia; Pregnancy Complications

Treatments: Drug: Venofer® (Vifor AG, St. Gallen, Switzerland); Drug: Ferli-6® (Continental Pharm co., ltd.)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00746551

296/2551(EC3)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Ferrous fumarate, Ferri-6®, Oral tablet

Active Comparator group

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.

Treatment:

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

iron sucrose, Venofer®, intravenous drug

Experimental group

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.

Treatment:

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