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Completed

NCT Number: NCT01628770

Use of Iron Isomaltoside 1000 (Monofer) in Postpartum Anemia

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

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Key information

Conditions

Postpartum Anemia

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dow University of Health Sciences

Karachi, Sindh, 74200, Pakistan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Iron Isomaltoside 1000

Drug

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.

Other names: Monofer

Ferrous sulphate

Drug

200mg twice daily

Primary outcomes

  1. To see the rise in hemoglobin concentration of 2gm/dl or more.

    Time frame: 3 months

    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 outcomes

  1. secondary - time required for rise in hemoglobin concentration

    Time frame: 3 months

    time required for rise in hemoglobin concentration. Both groups will be compared in terms of time interval, to see the rise in hemoglobin concentration.

Sponsors and collaborators

Lead sponsor

Dow University of Health Sciences

Other

Registry information

Official study title

Iron Isomaltoside 1000 (Monofer)

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 27, 2012
Registry last updated
Aug 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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