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Completed

NCT Number: NCT00660933

Intravenous Iron Versus Oral Iron for Severe Postpartum Anemia

The aim of the study is to compare the effect of intravenous versus oral iron in women with severe postpartum anemia.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Clínic of Barcelona

Barcelona, 08036, Spain

About this study

Postpartum anemia is commonly defined as hemoglobin levels less than 8.5 g/dl and it is usually treated with oral iron supplements. Blood transfusion is reserved to women with hemoglobin levels < 6 g/dl and/or clinical symptoms of anemia. Without treatment, the restoration of blood parameters in postpartum anemia can take approximately one month (hemoglobin levels increase to 2.8 g/dl in 30 days). Several reports have demonstrated the efficacy of intravenous iron in severe anemia in non-obstetric pathologies. However, the clinical effect of intravenous iron in patients with postpartum hemoglobin levels ranging from 6.0 to 8.0 g/dl has been not reported. There has not been evaluated its capacity to restore hemoglobin levels and to minimize clinical side-effects of anemia (sickness, weariness, depression, anxiety).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years and older,
  • Diagnosis of postpartum anemia within the first 48 h postpartum with an haemoglobin level equal or higher than 6 g/dL and lower than 8.0 g/dL,
  • Ability to read and understand the relevant purpose of the trial and consent obtained in accordance with specifications of the local research ethics committee.

Exclusion criteria

  • Clinical symptoms or suspicion of acute or chronic infection.
  • Allergic history or iron intolerance.
  • Indication of blood transfusion.
  • Non iron deficit anemia.
  • Hepatopathy.
  • Parenteral iron hypersensitivity.

Treatment and study plan

Iron sucrose

Drug

Iron sucrose 200 mg/day iv, (20 mg/ml) + 200 cc de NaCl 0,9%/day in 60 minutes per 2 days.

Other names: Venofer

NaCl

Drug

NaCl 0,9% 200 ml /day iv in 60 minutes per 2 days

Primary outcomes

  1. To evaluate if intravenous iron administration is better than oral treatment to improve hemoglobin and hematocrit parameters in women with severe postpartum anemia

    Time frame: 6 weeks

Secondary outcomes

  1. To compare if the administration of intravenous iron supplementation is better than the oral dosage to reestablish clinical symptoms of severe anemia minimizing its side-effects (weariness, depression, anxiety) or to avoid the need for blood transfusion

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Official study title

Intravenous Iron Versus Oral Iron for Severe Postpartum Anemia Randomized Trial

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Apr 17, 2008
Registry last updated
Mar 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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