Title

Treatment of Women After Postpartum Haemorrhage
A, Randomized Comparative, Open-Label Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by High Single Dose In-fusions or Standard Medical Care in Women After Postpartum Haemorrhage
  • Phase

    Phase 3
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Intervention/Treatment

    iron isomaltoside ...
  • Study Participants

    200
The primary purpose of this study is to compare the efficacy of IV high single dose infusion of iron isomaltoside 1000 to standard medical care in women with PPH evaluated as physical fatigue.
Study Started
Jun 30
2013
Primary Completion
Dec 31
2014
Study Completion
Dec 31
2014
Last Update
Apr 29
2015
Estimate

Drug Iron isomaltoside 1000

A single dose of 1200 mg iron isomaltoside 1000 is given. The dose is diluted in 100 ml 0.9 % sodium chloride and given over approximately 15 min.

  • Other names: Monofer®

Other Standard medical Care

Standard medical Care is most often to recommend women with PPH to continue oral iron supplementation as recommended during pregnancy or to advise the subject to take 100 mg oral iron 1-2 times a day

Iron isomaltoside 1000 (Monofer®) Experimental

Standard medical Care Active Comparator

Criteria

Inclusion Criteria:

Women with PPH ≥ 700 and ≤ 1000 mL or PPH > 1000 mL and Hb > 6.5 g/dL (4.0 mmol/L) measured > 12 hours after delivery
Willingness to participate and signed the informed consent form

Exclusion Criteria:

Women aged < 18 years
Multiple births
Peripartum RBC transfusion
Known iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis)
Known hypersensitivity to parenteral iron or any excipients in the investigational drug products
Women with a history of active asthma within the last 5 years or a history of multiple allergies
Known decompensated liver cirrhosis and active hepatitis
Women with HELLP (Haemolysis Elevated Liver enzymes Low Platelet count) syndrome (defined according to "Dansk Selskab for Obstetrik og Gynækologi guidelines")
Active acute infection assessed by clinical judgement
Rheumatoid arthritis with symptoms or signs of active joint inflammation
History of anaemia caused by e. g. thalassemia, hypersplenism or haemolytic anaemia (known haematologic disorder other than iron deficiency)
Not able to read, speak and understand the Danish language
Participation in any other clinical study where the study drug has not passed 5 half-lives prior to the baseline
Any other medical condition that, in the opinion of the Investigator, may cause the patient to be unsuitable for completion of the study or place the patient at potential risk from being in the study. For example, a malignancy, uncontrolled hypertension, unstable ischaemic heart disease or uncontrolled diabetes mellitus
No Results Posted