Treatment of Women After Postpartum Haemorrhage

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Postpartum Haemorrhage

Intervention / Treatment
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* Drug: Iron isomaltoside 1000
* Other: Standard medical Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iron isomaltoside 1000 (Monofer®)<br> | Drug: Iron isomaltoside 1000<br>* 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.<br>* Other names: Monofer®;|
| Active Comparator: Standard medical Care<br> | Other: Standard medical Care<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical fatigue | 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. | From exposure to 12 weeks post-exposure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hb concentration |  | From exposure to week 1, 3, 8 and 12 post-exposure | 
| Change in concentrations of p-ferritin |  | From exposure to day 3, week 1, 3, 8 and 12 post-exposure | 
| Change in Fatigue symptoms |  | From exposure to day 3, week 1, 3, 8 and 12 post-exposure | 
| Change in postpartum depression symptoms |  | From exposure to 12 weeks post-exposure | 
| Breastfeeding |  | From exposure to 12 weeks post-exposure | 
| RCB transfusions |  | From exposure to 12 weeks post-exposure | 
| Adverse drug reactions (ADRs) |  | From exposure to day 3, week 1, 3, 8 and 12 post-exposure | 
| Change in concentrations of p-iron |  | From exposure to day 3, week 1, 3, 8 and 12 post-exposure | 
| Change in concentrations of p-transferrin |  | From exposure to day 3, week 1, 3, 8 and 12 post-exposure | 
| Change in concentrations of transferrin saturation (TSAT) |  | From exposure to day 3, week 1, 3, 8 and 12 post-exposure | 
| Change in concentrations of reticulocyte count |  | From exposure to day 3, week 1, 3, 8 and 12 post-exposure | 
| Change in concentrations of mean reticulocyte haemoglobin content (CHr) |  | From exposure to day 3, week 1, 3, 8 and 12 post-exposure | 
| Change in haematology parameters |  | From exposure to day 3, week 1, 3, 8 and 12 post-exposure |