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Use of Iron Isomaltoside 1000 (Monofer) in Postpartum Anemia

Primary Purpose

Postpartum Anemia

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Iron isomaltoside 1000
Ferrous sulphate
Sponsored by
Dow University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Anemia focused on measuring iron, monofer, Pakistan

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Dow University of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

parenteral iron

oral iron

Arm Description

dose will be calculated according to Ganzoni's formula, and will be administered by intravenous infusion

oral iron in form of ferrous sulphate 200 mg twice daily

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 21, 2012
Last Updated
August 1, 2016
Sponsor
Dow University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01628770
Brief Title
Use of Iron Isomaltoside 1000 (Monofer) in Postpartum Anemia
Official Title
Iron Isomaltoside 1000 (Monofer)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dow University of Health Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Anemia
Keywords
iron, monofer, Pakistan

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
271 (Actual)

8. Arms, Groups, and Interventions

Arm Title
parenteral iron
Arm Type
Experimental
Arm Description
dose will be calculated according to Ganzoni's formula, and will be administered by intravenous infusion
Arm Title
oral iron
Arm Type
Active Comparator
Arm Description
oral iron in form of ferrous sulphate 200 mg twice daily
Intervention Type
Drug
Intervention Name(s)
Iron isomaltoside 1000
Other Intervention Name(s)
Monofer
Intervention 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. It can be given in a dose of 20mg/kg body weight.
Intervention Type
Drug
Intervention Name(s)
Ferrous sulphate
Intervention Description
200mg twice daily
Primary Outcome Measure Information:
Title
To see the rise in hemoglobin concentration of 2gm/dl or more.
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
secondary - time required for rise in hemoglobin concentration
Description
time required for rise in hemoglobin concentration. Both groups will be compared in terms of time interval, to see the rise in hemoglobin concentration.
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Dow University of Health Sciences
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74200
Country
Pakistan

12. IPD Sharing Statement

Citations:
PubMed Identifier
29558233
Citation
Holm C, Thomsen LL, Langhoff-Roos J. Intravenous iron isomaltoside treatment of women suffering from severe fatigue after postpartum hemorrhage. J Matern Fetal Neonatal Med. 2019 Sep;32(17):2797-2804. doi: 10.1080/14767058.2018.1449205. Epub 2018 Mar 20.
Results Reference
derived

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Use of Iron Isomaltoside 1000 (Monofer) in Postpartum Anemia

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