We found lower prevalence and earlier onset of symptoms compared to previous studies and confirmed significant improvement after delivery. RLS is clinically relevant due to severe impact on sleep quality. Genetic factors and smoking, but not ferritin, anemia, or estrogen levels, seem to play a role in the pathophysiology of RLS in pregnancy.

Open-label study of the efficacy and safety of intravenous ferric carboxymaltose in pregnant women with restless legs syndrome, Sleep Medicine (2015), http://dx.doi.org/doi: 10.1016/j.sleep.2015.08.006. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. Neurocenter of Southern Switzerland (Lugano). Patient and Methods:Nineteen women in the third trimester of pregnancy with moderateto-severe RLS and serum ferritin levels <35 µg/L or hemoglobin (Hb) <11.0 g/dl were included in the study. RLS was graded according to the International Restless Legs Syndrome (IRLS) Study Group rating scale. All participants had a score of ≥20 or had RLS ≥3 times/week. Depending on Hb levels, 500 or 700 mg of FCM was administered over 20 min. The primary endpoint was a ≥50% reduction in the mean IRLS score 1 week after FCM infusion. Secondary endpoints included periodic limb movements (PLMs; assessed using nocturnal foot actigraphy), sleep quality (assessed using the Pittsburgh Sleep Quality Index), and safety. Results:The IRLS score decreased from 23 ± 7 (baseline) to 13 ± 7 (P < 0.01), whereas the PLM index decreased from 35 ± 26 (baseline) to 25 ± 20 (P < 0.001). Significant improvement in sleep quality was also reported (P < 0.029), and treatment was well tolerated. Three serious adverse events were reported but were considered unrelated to treatment. Conclusions:These data provides promising evidence of the safety and efficacy of FCM for moderate-to-severe RLS in pregnant women with iron deficiency or anemia. A future placebo-controlled study is therefore warranted.

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