Clinical trial NCT00660933: Intravenous Iron Versus Oral Iron for Severe Postpartum Anemia
Official title: Intravenous Iron Versus Oral Iron for Severe Postpartum Anemia Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anemia
Puerperal Disorders
Keywords: postpartum anemia
intravenous iron
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2008-04-17
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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).

Eligibility criteria: Inclusion Criteria:

1. 18 years and older,
2. 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,
3. 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:

1. Clinical symptoms or suspicion of acute or chronic infection.
2. Allergic history or iron intolerance.
3. Indication of blood transfusion.
4. Non iron deficit anemia.
5. Hepatopathy.
6. Parenteral iron hypersensitivity.

Primary outcomes:
measure: To evaluate if intravenous iron administration is better than oral treatment to improve hemoglobin and hematocrit parameters in women with severe postpartum anemia
timeFrame: 6 weeks
Secondary outcomes:
measure: 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
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic of Barcelona
Study officials:
affiliation: Servei de Medicina Maternofetal. Institut de Ginecologia, Obstetrícia i Neonatología. Hospital Clínic. Universitat de Barcelona
name: Montse Palacio, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Perello MF, Coloma JL, Masoller N, Esteve J, Palacio M. Intravenous ferrous sucrose versus placebo in addition to oral iron therapy for the treatment of severe postpartum anaemia: a randomised controlled trial. BJOG. 2014 May;121(6):706-13. doi: 10.1111/1471-0528.12480. Epub 2014 Jan 15.