Intravenous Iron Versus Oral Iron for Severe Postpartum Anemia

Anemia Clinical Trial

Official title:

Intravenous Iron Versus Oral Iron for Severe Postpartum Anemia Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00660933
• Other study ID #: POSTPARTFEEV
• Status: Completed
• Phase: Phase 4
• First received: April 14, 2008
• Last updated: March 7, 2016
• Start date: September 2005
• Est. completion date: September 2007

Study information

• Verified date: September 2005
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Puerperal Disorders

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Clínic of Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Perelló 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate if intravenous iron administration is better than oral treatment to improve hemoglobin and hematocrit parameters in women with severe postpartum anemia		6 weeks
Secondary	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		6 weeks