Clinical trial NCT01895218: Treatment of Women After Postpartum Haemorrhage
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postpartum Haemorrhage
Lead sponsor: Pharmacosmos A/S
Sponsor class: INDUSTRY
Collaborators: name: BioStata
First posted: 2013-07-10
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. 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
2. Willingness to participate and signed the informed consent form

Exclusion Criteria:

1. Women aged \< 18 years
2. Multiple births
3. Peripartum RBC transfusion
4. Known iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis)
5. Known hypersensitivity to parenteral iron or any excipients in the investigational drug products
6. Women with a history of active asthma within the last 5 years or a history of multiple allergies
7. Known decompensated liver cirrhosis and active hepatitis
8. Women with HELLP (Haemolysis Elevated Liver enzymes Low Platelet count) syndrome (defined according to "Dansk Selskab for Obstetrik og Gynækologi guidelines")
9. Active acute infection assessed by clinical judgement
10. Rheumatoid arthritis with symptoms or signs of active joint inflammation
11. History of anaemia caused by e. g. thalassemia, hypersplenism or haemolytic anaemia (known haematologic disorder other than iron deficiency)
12. Not able to read, speak and understand the Danish language
13. Participation in any other clinical study where the study drug has not passed 5 half-lives prior to the baseline
14. 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

Primary outcomes:
measure: Physical fatigue
timeFrame: From exposure to 12 weeks post-exposure
Secondary outcomes:
measure: Change in Hb concentration
timeFrame: From exposure to week 1, 3, 8 and 12 post-exposure
measure: Change in concentrations of p-ferritin
timeFrame: From exposure to day 3, week 1, 3, 8 and 12 post-exposure
measure: Change in Fatigue symptoms
timeFrame: From exposure to day 3, week 1, 3, 8 and 12 post-exposure
measure: Change in postpartum depression symptoms
timeFrame: From exposure to 12 weeks post-exposure
measure: Breastfeeding
timeFrame: From exposure to 12 weeks post-exposure
measure: RCB transfusions
timeFrame: From exposure to 12 weeks post-exposure
measure: Adverse drug reactions (ADRs)
timeFrame: From exposure to day 3, week 1, 3, 8 and 12 post-exposure
measure: Change in concentrations of p-iron
timeFrame: From exposure to day 3, week 1, 3, 8 and 12 post-exposure
measure: Change in concentrations of p-transferrin
timeFrame: From exposure to day 3, week 1, 3, 8 and 12 post-exposure
measure: Change in concentrations of transferrin saturation (TSAT)
timeFrame: From exposure to day 3, week 1, 3, 8 and 12 post-exposure
measure: Change in concentrations of reticulocyte count
timeFrame: From exposure to day 3, week 1, 3, 8 and 12 post-exposure
measure: Change in concentrations of mean reticulocyte haemoglobin content (CHr)
timeFrame: From exposure to day 3, week 1, 3, 8 and 12 post-exposure
measure: Change in haematology parameters
timeFrame: From exposure to day 3, week 1, 3, 8 and 12 post-exposure
Other outcomes:
measure: Change in anaemia symptoms
timeFrame: From exposure to day 3, week 1, 3, 8 and 12 post-exposure
measure: Change in gastrointestinal symptoms
timeFrame: From exposure to day 3, week 1, 3, 8 and 12 post-exposure
Locations:
city: Copenhagen
country: Denmark
Study officials:
References:
citation: Holm C, Thomsen LL, Langhoff-Roos J. Intravenous iron isomaltoside treatment of women suffering from severe fatigue after postpartum hemorrhage. J Matern Fetal Neonatal Med. 2019 Sep;32(17):2797-2804. doi: 10.1080/14767058.2018.1449205. Epub 2018 Mar 20.
citation: Holm C, Thomsen LL, Norgaard A, Langhoff-Roos J. Intravenous iron isomaltoside 1000 administered by high single-dose infusions or standard medical care for the treatment of fatigue in women after postpartum haemorrhage: study protocol for a randomised controlled trial. Trials. 2015 Jan 14;16:5. doi: 10.1186/1745-6215-16-5.