Iron Deficiency Anemia Clinical Trial
Official title:
Exploratory Study of the Efficacy, Practicability and Safety of Intravenous Iron Supplementation Therapy in Moderate to Severe Restless Legs Syndrome With Iron Deficiency or Anaemia in the 3rd Trimester of Pregnancy
In pregnancy Restless Legs Syndrome(RLS) is more common than in the general population.
During pregnancy iron tablets are the only available safe medication but their efficacy is
rather poor. It is the aim of this study to examine the efficacy, practicability and safety
of the drug Ferinject® containing the active agent Ferric carboxymaltose for the therapy of
Restless Legs Syndrome(RLS) during pregnancy in the case of iron deficiency or anaemia.
20 women with RLS and iron deficiency and/ or anaemia in the third trimester of pregnancy
will receive intravenous Ferric carboxymaltose in one or two single doses. Repeated blood
tests, pre-and post-therapy actigraphy as well as repeated answering of questionnaires
concerning Restless Legs Syndrome(RLS)-symptoms and sleep quality will show the effect of
iv-Iron supplementation on Restless Legs Syndrome(RLS)-symptoms during pregnancy.
- Trial with medicinal product
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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