Intravenous Versus Oral Iron in Late Pregnancy: Results of Treatment

NCT00746551 | Completed Phase 4 Results DMC

• 1 other identifier: 296/2551(EC3)
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia; Pregnancy Complications

Keywords

iron deficiency anemia; pregnancy; third trimester; intravenous iron; efficacy; a randomized trial; Female; Ferric Compounds/therapeutic use*; Infusions, Intravenous; Hematologic/therapy*

Outcome Measures

Primary Outcomes (1)

• Serum Ferritin Level

  3 weeks after intervention

Secondary Outcomes (1)

• Haemoglobin Level

  3 weeks after intervention

Study Arms (2)

Ferrous fumarate, Ferri-6®, Oral tablet

ACTIVE COMPARATOR

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.)

iron sucrose, Venofer®, intravenous drug

EXPERIMENTAL

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)

Interventions

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.

Ferrous fumarate, Ferri-6®, Oral tablet

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.

iron sucrose, Venofer®, intravenous drug

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Stool exam revealed parasitic infestation
• C-reactive protein \> 3 mg/L
• Serum ferritin \> 15 mcg/L

Sponsors & Collaborators

• Mahidol University: lead
• Vifor Pharma: collaborator

Study Sites (1)

Siriraj Hospital, Mahidol University

Bangkok, Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Anemia; Pregnancy Complications; Anemia, Iron-Deficiency

Interventions

Long-Term Synaptic Depression; Ferric Oxide, Saccharated

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Neuronal Plasticity; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Results Point of Contact

• Title: Pharuhas Chanprapaph
• Organization: Mahidol University, Department of Obstetrics and Gynaecology, Division of Maternal Fetal Medicine, Faculty of Medicine, Siriraj Hospital

pharuhasc@gmail.com

+66819920053

Study Officials

• Pornpimol Ruangvutilert, MD, PhD.

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 2, 2008
• First Posted: September 4, 2008
• Study Start: September 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: April 1, 2010
• Last Updated: February 16, 2015
• Results First Posted: February 16, 2015

Record last verified: 2015-02

Locations

TH (1)