Copenhagen, Denmark
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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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
Female
Study type
Interventional
Phase
Phase 3
Primary location
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
DrugA 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
OtherStandard 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
-
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
-
Change in Hb concentration
Time frame: From exposure to week 1, 3, 8 and 12 post-exposure
-
Change in concentrations of p-ferritin
Time frame: From exposure to day 3, week 1, 3, 8 and 12 post-exposure
-
Change in Fatigue symptoms
Time frame: From exposure to day 3, week 1, 3, 8 and 12 post-exposure
-
Change in postpartum depression symptoms
Time frame: From exposure to 12 weeks post-exposure
-
Breastfeeding
Time frame: From exposure to 12 weeks post-exposure
-
RCB transfusions
Time frame: From exposure to 12 weeks post-exposure
-
Adverse drug reactions (ADRs)
Time frame: From exposure to day 3, week 1, 3, 8 and 12 post-exposure
-
Change in concentrations of p-iron
Time frame: From exposure to day 3, week 1, 3, 8 and 12 post-exposure
-
Change in concentrations of p-transferrin
Time frame: From exposure to day 3, week 1, 3, 8 and 12 post-exposure
-
Change in concentrations of transferrin saturation (TSAT)
Time frame: From exposure to day 3, week 1, 3, 8 and 12 post-exposure
-
Change in concentrations of reticulocyte count
Time frame: From exposure to day 3, week 1, 3, 8 and 12 post-exposure
-
Change in concentrations of mean reticulocyte haemoglobin content (CHr)
Time frame: From exposure to day 3, week 1, 3, 8 and 12 post-exposure
-
Change in haematology parameters
Time frame: From exposure to day 3, week 1, 3, 8 and 12 post-exposure
Other outcomes
-
Change in anaemia symptoms
Time frame: From exposure to day 3, week 1, 3, 8 and 12 post-exposure
-
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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