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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
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.
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
Unnamed facility
Copenhagen, Denmark
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.
Time frame: From exposure to 12 weeks post-exposure
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
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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