Study design
This prospective, randomized, controlled, and doubleblinded
study was conducted at a tertiary care university
hospital with an average of 4,600 births per year, in
the period between March 2011 and April 2014.The
study was approved by the Ethics Committee of the
General University Hospital in Prague (MZ10-UK1LFSlanar)
and registered at the Clinical Trials Database
(ClinicalTrials.gov NCT01550640). Study was conducted
in accordance with Helsinki Declaration principles. Signed
informed consent was obtained from each participant.