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Completed

NCT Number: NCT01895218

Treatment of Women After Postpartum Haemorrhage

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.

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Key information

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Iron Isomaltoside 1000

Drug

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®

Standard Medical Care

Other

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 outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Pharmacosmos A/S

Industry

Collaborators

  • BioStata

Registry information

Official study 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

Acronym: PP-01

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 10, 2013
Registry last updated
Apr 29, 2015

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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