Use of Iron Isomaltoside 1000 (Monofer) in Postpartum Anemia
Iron Isomaltoside 1000 (Monofer)
1 other identifier
interventional
271
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 21, 2012
CompletedFirst Posted
Study publicly available on registry
June 27, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedAugust 3, 2016
August 1, 2016
7 months
June 21, 2012
August 1, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
secondary - time required for rise in hemoglobin concentration
3 months
Study Arms (2)
parenteral iron
EXPERIMENTALdose will be calculated according to Ganzoni's formula, and will be administered by intravenous infusion
oral iron
ACTIVE COMPARATORoral iron in form of ferrous sulphate 200 mg twice daily
Interventions
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.
Eligibility Criteria
You may qualify if:
- Women within 24-48 hours of delivery with hemoglobin concentration \< 10gm/dl
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dow University of Health Sciences
Karachi, Sindh, 74200, Pakistan
Related Publications (1)
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.
PMID: 29558233DERIVED
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 21, 2012
First Posted
June 27, 2012
Study Start
May 1, 2012
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
August 3, 2016
Record last verified: 2016-08