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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
20 women with Restless Legs Syndrome (RLS) and iron deficiency and/ or anaemia in the third trimester of pregnancy will receive intravenous Ferric carboxymaltose in one or two single doses.
University Hospital Zurich, Neurology
Zurich, Canton of Zurich, Switzerland
Neurocenter of Southern Switzerland, Ospedale Civico
Lugano, Canton Ticino, Switzerland
Primary endpoint: = 50% reduction of RLS symptoms as measured by International Restless Legs Study Group (IRLSS)
Time frame: 3 days, 7 days, 14 days, 28 days, and 60 days after iron infusion
Reduction of Periodic Limb Movements in Sleep (PLMS) ≥50% as measured with actimetry
Time frame: screening, 7 days, 14 days after iron infusion
Improvement of sleep according to the Pittsburgh Sleep Quality Questionnaire (PSQI)
Time frame: screening, 7 days after iron infusion, 14 days post partum
Improvement of sleepiness using Epworth Sleepiness Scale (ESS)
Time frame: screening, 7 days, 14 days, 28 days after iron infusion, 14 days post partum
Improvement of fatigue using Fatigue Severity Scale (FSS)
Time frame: screening, 7 days, 14 days, 28 days after iron infusion, 14 days post partum
Safety of ferric carboxymaltose during pregnancy in the 3rd trimester
Recording of adverse events
Time frame: Day 1, Day 3, Day 7, Day 14, Day 28, 14 days pre partum, 14 days post partum
Parameters of the newborn baby (apgar, umbilical artery pH, weight, mode of delivery)
Time frame: 8 weeeks
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