Use of Iron Isomaltoside 1000 (Monofer) in Postpartum Anemia

Postpartum Anemia Clinical Trial

Official title:

Iron Isomaltoside 1000 (Monofer)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01628770
• Other study ID #: 7865
• Status: Completed
• Phase: N/A
• First received: June 21, 2012
• Last updated: August 1, 2016
• Start date: May 2012
• Est. completion date: December 2012

Study information

• Verified date: August 2016
• Source: Dow University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The investigators hypothesized that both isomaltoside 1000 (Monofer), and oral iron preparation will be equally effective in correction of postpartum iron deficiency anemia.

Description:

Iron molecule iron isomaltoside 1000 (Monofer) have been introduced in the market, which can be given in intravenous infusion forms, in a relatively short period of time, in a single setting, after calculation of the required dose. This preparation has been used for treatment of anemia in patients with chronic renal disease, gastrointestinal disorders, anemia of malignancy and in gynecological disorders. It does not require a test dose to be given before total dose, nor does it require any premedication. It can be given in a dose of 20mg/kg. The drug has been licensed for use in Europe in 2009. It has been used for treatment of anemia in patients with chronic renal disease, inflammatory bowel disease and in anemia due to malignancies

Recruitment information / eligibility

• Status: Completed
• Enrollment: 271
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Women within 24-48 hours of delivery with hemoglobin concentration < 10gm/dl

Exclusion Criteria:

• History of PPH, or significant blood loss in last 24 hours

• History of allergy to iron preparation

• Hemoglobin < 7gm/dl.

• Sign & symptoms of cardiac failure

• H/o blood transfusion in last 3 months

• H/O Chronic liver diseases.

• ? Creatinine > 2mg/dl.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anemia
• Postpartum Anemia

Intervention

Drug:
• Iron isomaltoside 1000
Iron molecule iron isomaltoside 1000 (Monofer) have been introduced in the market, which can be given in intravenous infusion forms, in a relatively short period of time, in a single setting, after calculation of the required dose. It can be given in a dose of 20mg/kg body weight.
• Ferrous sulphate
200mg twice daily

Locations

Country	Name	City	State
Pakistan	Dow University of Health Sciences	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Dow University of Health Sciences

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To see the rise in hemoglobin concentration of 2gm/dl or more.	To see the rise in hemoglobin concentration of 2gm/dl or more.This rise in hemoglobin concentration will be measured at day 14 and at 3 months, in both groups.	3 months	No
Secondary	secondary - time required for rise in hemoglobin concentration	time required for rise in hemoglobin concentration. Both groups will be compared in terms of time interval, to see the rise in hemoglobin concentration.	3 months	No