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Treatment of Women After Postpartum Haemorrhage (PP-01)

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ClinicalTrials.gov Identifier: NCT01895218
Recruitment Status : Completed
First Posted : July 10, 2013
Last Update Posted : April 29, 2015
Sponsor:
Collaborator:
BioStata
Information provided by (Responsible Party):
Pharmacosmos A/S

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.

Condition or disease Intervention/treatment Phase
Postpartum Haemorrhage Drug: Iron isomaltoside 1000 Other: Standard medical Care Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2013
Primary Completion Date : December 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Iron isomaltoside 1000 (Monofer®) 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 Name: Monofer®
Active Comparator: Standard medical Care 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



Primary Outcome Measures :
  1. Physical fatigue [ Time Frame: From exposure to 12 weeks post-exposure ]
    The primary objective of this study is to compare efficacy of IV high single dose infusion of iron isomaltoside 1000 to standard medical care in women with PPH evaluated as physical fatigue.


Secondary Outcome Measures :
  1. Change in Hb concentration [ Time Frame: From exposure to week 1, 3, 8 and 12 post-exposure ]
  2. Change in concentrations of p-ferritin [ Time Frame: From exposure to day 3, week 1, 3, 8 and 12 post-exposure ]
  3. Change in Fatigue symptoms [ Time Frame: From exposure to day 3, week 1, 3, 8 and 12 post-exposure ]
  4. Change in postpartum depression symptoms [ Time Frame: From exposure to 12 weeks post-exposure ]
  5. Breastfeeding [ Time Frame: From exposure to 12 weeks post-exposure ]
  6. RCB transfusions [ Time Frame: From exposure to 12 weeks post-exposure ]
  7. Adverse drug reactions (ADRs) [ Time Frame: From exposure to day 3, week 1, 3, 8 and 12 post-exposure ]
  8. Change in concentrations of p-iron [ Time Frame: From exposure to day 3, week 1, 3, 8 and 12 post-exposure ]
  9. Change in concentrations of p-transferrin [ Time Frame: From exposure to day 3, week 1, 3, 8 and 12 post-exposure ]
  10. Change in concentrations of transferrin saturation (TSAT) [ Time Frame: From exposure to day 3, week 1, 3, 8 and 12 post-exposure ]
  11. Change in concentrations of reticulocyte count [ Time Frame: From exposure to day 3, week 1, 3, 8 and 12 post-exposure ]
  12. Change in concentrations of mean reticulocyte haemoglobin content (CHr) [ Time Frame: From exposure to day 3, week 1, 3, 8 and 12 post-exposure ]
  13. Change in haematology parameters [ Time Frame: From exposure to day 3, week 1, 3, 8 and 12 post-exposure ]

Other Outcome Measures:
  1. Change in anaemia symptoms [ Time Frame: From exposure to day 3, week 1, 3, 8 and 12 post-exposure ]
  2. Change in gastrointestinal symptoms [ Time Frame: From exposure to day 3, week 1, 3, 8 and 12 post-exposure ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. Willingness to participate and signed the informed consent form

Exclusion Criteria:

  1. Women aged < 18 years
  2. Multiple births
  3. Peripartum RBC transfusion
  4. Known iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis)
  5. Known hypersensitivity to parenteral iron or any excipients in the investigational drug products
  6. Women with a history of active asthma within the last 5 years or a history of multiple allergies
  7. Known decompensated liver cirrhosis and active hepatitis
  8. Women with HELLP (Haemolysis Elevated Liver enzymes Low Platelet count) syndrome (defined according to "Dansk Selskab for Obstetrik og Gynækologi guidelines")
  9. Active acute infection assessed by clinical judgement
  10. Rheumatoid arthritis with symptoms or signs of active joint inflammation
  11. History of anaemia caused by e. g. thalassemia, hypersplenism or haemolytic anaemia (known haematologic disorder other than iron deficiency)
  12. Not able to read, speak and understand the Danish language
  13. Participation in any other clinical study where the study drug has not passed 5 half-lives prior to the baseline
  14. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01895218


Locations
Denmark
Copenhagen, Denmark
Sponsors and Collaborators
Pharmacosmos A/S
BioStata

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pharmacosmos A/S
ClinicalTrials.gov Identifier: NCT01895218     History of Changes
Other Study ID Numbers: PP-01
First Posted: July 10, 2013    Key Record Dates
Last Update Posted: April 29, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Hemorrhage
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Iron
Ferric Compounds
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics