Intravenous Iron Versus Oral Iron for Severe Postpartum Anemia

H

Hospital Clinic of Barcelona

Status and phase

Completed
Phase 4

Conditions

Anemia
Puerperal Disorders

Treatments

Drug: Iron sucrose
Drug: NaCl

Study type

Interventional

Funder types

Other

Identifiers

NCT00660933
POSTPARTFEEV

Details and patient eligibility

About

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

Full description

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).

Enrollment

70 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

70 participants in 2 patient groups, including a placebo group

Group A
Active Comparator group
Description:
Group A: Administration of intravenous iron sucrose.
Treatment:
Drug: Iron sucrose
Group B
Placebo Comparator group
Description:
Group B: Administration of intravenous NaCl 0,9%.
Treatment:
Drug: NaCl

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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