CompletedPhase 3

Treatment of Women After Severe Postpartum Haemorrhage

Denmark13 participantsStarted 2013-06

Plain-language summary

The primary purpose of this study is to get explorative information about IV high single dose infusion of iron isomaltoside 1000 compared to RBC transfusion in the treatment of severe PP-IDA evaluated as physical fatigue

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. PPH \> 1000 mL
✓. Hb ≥ 5.5 and ≤ 8.0 g/dL (≥ 3.5 and ≤ 5.0 mmol/L)
✓. 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")

What they're measuring

Physical Fatigue

Timeframe: From exposure to 12 weeks post-exposure

Trial details

NCT IDNCT01895205

SponsorPharmacosmos A/S

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-08

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