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Intravenous Versus Oral Iron in Late Pregnancy: Results of Treatment

NCT00746551 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2015-02-16

Study results available
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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

Interventions

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.

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.

Sponsors & Collaborators

  • Vifor Pharma

    collaborator INDUSTRY

  • Mahidol University

    lead OTHER

Principal Investigators

  • Pornpimol Ruangvutilert, MD, PhD. · Obstetrics and Gynecology Department, Faculty of Medicine Siriraj Hosptial, Mahidol University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2010-03-31
Completion
2010-04-30

Countries

  • Thailand

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00746551 on ClinicalTrials.gov