Status:
COMPLETED
Treatment of Women After Postpartum Haemorrhage
Lead Sponsor:
Pharmacosmos A/S
Collaborating Sponsors:
BioStata
Conditions:
Postpartum Haemorrhage
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01895218
Start Date
June 1 2013
End Date
December 1 2014
Last Update
April 29 2015
Active Locations (1)
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1
Copenhagen, Denmark