Table 2 Postrandomization criteria for withdrawal from the study

Delivery related

 (a) caesarean section or instrumental delivery (forceps, vacuum)

 (b) maternal fever > 38 °C

 (c) maternal hemodynamic instability (hypotension, tachycardia, impaired consciousness, poor perfusion, notable pallor) or any other type of ailment

 (d) umbilical cord prolapsed

 (e) signs of fetal “distress”, with fetal scalp pH < 7.25 or umbilical artery pH < 7.20

 (f) any other obstetric complication

 (g) use of sedatives or relaxants during or after delivery

Neonate related

 (a) need for resuscitation measures

 (b) intrapartum-diagnosed major malformation

 (c) Apgar score ≤ 7 at 1, 5, or 10 min

 (d) presence of symptoms before 10 min of life

 (e) birth weight < 2300 g or > 4500 g