Sustained Cord Circulation at Emergency Cesarean Section

Study Title Sustained Cord Circulation During Resuscitation of Non-Breathing Neonates Born by Cesarean Section: A Multicenter Randomized Controlled Trial Primary Objectives: To compare neonatal outcomes between two different approaches to resuscitation of term neonates born by CS; Intact cord resuscitation versus standard care with immediate cord clamping, and evaluate: A composite outcome of admission to neonatal care for predefined criteria or death before admission. Predefined criteria include asphyxia at birth, respiratory distress, hypoxic ischemic encephalopathy (HIE) and hypoglycemia. Assessed within one week after birth. Secondary Objectives: Secondary outcomes will include short and long-term neonatal outcomes, adverse maternal and neonatal outcomes, and caregivers' and staff's experiences. Study Design: A multicenter, stepped-wedge cluster randomized trial. Study Population: Singleton neonate born alive, gestational age ≥37 weeks, born by emergency cesarean section, epidural/spinal anesthesia. Pediatric team summoned before birth due to health concerns regarding the neonate. Intervention: Resuscitation with intact cord circulation during 3-5 minutes. When in need of respiratory support, the neonate will be kept close to the mother with the cord intact and the placenta attached to the uterine wall. The pediatric team will give respiratory support with sustained cord circulation, following Swedish neonatal CPR guidelines. Cord clamping will be performed after respiration has been established and at the earliest after three minutes. Cord clamping will be performed at the latest at 5 minutes. Control: Resuscitation will be performed after the cord was cut. When in need of respiratory support, the cord will be clamped immediately, and the neonate will be taken to an adjacent place for resuscitation according to Swedish neonatal CPR guidelines. Well neonates will have their cord clamped after 1 minute in accordance with national recommendations. Power analysis: At a significant level of 0.05, the power to detect the anticipated risk reduction (15%) would be 0.88 (two-sided). Study Duration 2025-2028