Treatment of Women After Postpartum Haemorrhage
Phase 3
Completed
- Conditions
- Postpartum Haemorrhage
- Interventions
- Other: Standard medical Care
- Registration Number
- NCT01895218
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 200
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard medical Care Standard medical Care - Iron isomaltoside 1000 (Monofer®) Iron isomaltoside 1000 -
- Primary Outcome Measures
Name Time Method Physical fatigue 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
Name Time Method 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