Sustained Cord Circulation at Emergency Cesarean Section
NCT Number: NCT06540222
Acronym: SUCCECS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Asphyxia Neonatorum|Fetal Hypoxia
Interventions: PROCEDURE: Sustained cord (≥ 180 seconds) resuscitation|PROCEDURE: Routine (< 60 seconds) cord clamping
Sponsor: Region Skane
Sex: ALL
Age: CHILD
Enrollment: 1993
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-05
Completion Date: 2028-03

Summary:
The goal of this clinical trial is to evaluate if sustained cord circulation during resuscitation improves outcomes for term neonates born by emergency Cesarean section. The main question it aims to answer is: Does sustained cord circulation reduce admission rates to neonatal care?

Researchers will compare resuscitation with sustained cord circulation to standard resuscitation practices to see if it provides better outcomes.

Participants (term neonates born by emergency Cesarean section) will:

Receive resuscitation with either sustained cord circulation or standard care Be monitored for admission to neonatal care and other predefined health outcomes

Primary Outcome Measures: Composite outcome of admission to neonatal care for predefined criteria and death before admission., Admission to neonatal care is collected from the Swedish Neonatal Quality registry (SNQ), as are criteria for admission:• Asphyxia at birth (One-, Five- and/or Ten-minute Apgar score \<4), diagnosis P21.0, P21.1A, P21.1B or P21.9.• Respiratory distress (Noted in SNQ as NAS, neonatal respiratory distress P22.8, PAS, pulmonary adaption disturbance P 22.1, RDS, respiratory distress syndrome P22.0, MAS meconium aspiration syndrome P24.0, PPHN, Persistant Pulmonary Hypertension P29.3B, or PTX, Pneumothorax P25.1).• Hypoxic-ischemic encephalopathy grade I-III, P91.6A, B, C, or X.• Hypoglycemia, P 70.4A, or B. Death of the neonate before admission is collected from Swedish pregnancy registry.

Units of measure is dichotomous, as appearance of the diagnoses or not., At one hour after birth
Secondary Outcome Measures: Apgar score at 5 min, Assessed by staff, composite of heart rate, breathing effort, skin color, muscle tone and reflexes, each sub scale 0 (absent), 1, 2 (normal). Minimum 0, maximum 10. Less than 4 is a measure for severe asphyxia, less than 7 measure of mild asphyxia., 5 minutes|Apgar score at 10 min, Assessed by staff, composite of heart rate, breathing effort, skin color, muscle tone and reflexes, each sub scale 0 (absent), 1, 2 (normal). Minimum 0, maximum 10. Less than 4 is a measure for severe asphyxia, less than 7 measure of mild asphyxia., 10 minutes|Respiratory distress as a diagnosis after birth, Having the at least one of the following diagnosis in the Swedish neonatal quality registry: NAS, neonatal respiratory distress P22.8, PAS, pulmonary adaption disturbance P 22.1, RDS, respiratory distress syndrome P22.0, MAS meconium aspiration syndrome P24.0, PPHN, Persistent Pulmonary Hypertension P29.3B, or PTX, Pneumothorax P25.1., One week after birth|Hypoxic-ischemic encephalopathy as a diagnosis after birth, Having the at least one of the following diagnosis in the Swedish neonatal quality registry: Hypoxic-ischemic encephalopathy grade I-III, P91.6A, B, C, or X., One week after birth|Hypoglycemia as a diagnosis after birth, Having the at least one of the following diagnosis in the Swedish neonatal quality registry: Hypoglycemia, P 70.4A, or B., One week after birth|Duration of neonatal care, Duration of neonatal care as noted in the Swedish pregnancy register and Swedish neonatal quality registry: Aggregated as day (continuous) and ≥ 2 days, dichotomous, One month|Death after birth but before admission to neonatal unit, Noted as dead after birth in the Swedish pregnancy register, One hour after birth|Infant mortality, Death after one hour after birth, One year|Development assessed by ASQ at 12 months of age, Assessed by Ages and Stages Questionnaire (ASQ). Minimum 0, maximum 300. Consist of 30 questions answered Yes (10), Sometimes (5), Not Yet (0). Five sub scales with six questions each: Communication, Fine motor, Gross motor, Problem solving and Personal-Social. Worse outcome is considered mean minus 2 standard deviations. 'At risk' outcome is considered mean minus 1 standard deviations., 12 months
Other Outcome Measures: Neonatal outcomes - breathing, After birth (data registered on the resuscitation chart or imported from monitor equipment):

Initiation and establishment of breathing (Minutes and seconds), Birth to one hour|Neonatal outcomes - temperature, After birth (data registered on the resuscitation chart or imported from monitor equipment):

Temperature (degrees Celsius), Birth to six hours|Neonatal outcomes - interventions, After birth (data registered on the resuscitation chart or imported from monitor equipment):

Interventions (e.g. ventilation, intubation, chest compressions) noted on the resuscitation chart, Birth to one hour|Neonatal outcomes - heart rate, After birth (data registered on the resuscitation chart or imported from monitor equipment):

Data from Heart rate and Oxygen saturation monitoring

Unit of measure: Heart rate, Birth to 24 hours|Neonatal outcomes - oxygen saturation, After birth (data registered on the resuscitation chart or imported from monitor equipment):

Data from Heart rate and Oxygen saturation monitoring

Unit of measure: Oxygen saturation, Birth to 24 hours|Neonatal morbidity, During neonatal care (diagnosis from registries):

Neonatal seizures Neonatal infection Neonatal jaundice Intracranial hemorrhage

Unit of measure: Diagnosis occurring in Swedish Neonatal Quality registry, Birth to one month|Maternal outcomes - maternal blood loss, Maternal blood loss (Amount of postpartum bleeding, ml) Severe post-partum hemorrhage (\> 1000 ml) Maternal post-surgery infection, Birth to one month|Maternal outcomes, Severe post-partum hemorrhage (\> 1000 ml) Maternal post-surgery infection

Unit of measure: Diagnosis occurring in Swedish Pregnancy registry, Birth to one month|Development, Assessed by Ages and Stages Questionnaire (ASQ). Minimum 0, maximum 300. Consist of 30 questions answered Yes (10), Sometimes (5), Not Yet (0). Five sub scales with six questions each: Communication, Fine motor, Gross motor, Problem solving and Personal-Social. Worse outcome is considered mean minus 2 standard deviations. 'At risk' outcome is considered mean minus 1 standard deviations., 24 months|Development, Assessed by Ages and Stages Questionnaire (ASQ). Minimum 0, maximum 300. Consist of 30 questions answered Yes (10), Sometimes (5), Not Yet (0). Five sub scales with six questions each: Communication, Fine motor, Gross motor, Problem solving and Personal-Social. Worse outcome is considered mean minus 2 standard deviations. 'At risk' outcome is considered mean minus 1 standard deviations., 36 months|Development, Assessed by Ages and Stages Questionnaire (ASQ). Minimum 0, maximum 300. Consist of 30 questions answered Yes (10), Sometimes (5), Not Yet (0). Five sub scales with six questions each: Communication, Fine motor, Gross motor, Problem solving and Personal-Social. Worse outcome is considered mean minus 2 standard deviations. 'At risk' outcome is considered mean minus 1 standard deviations., 48 months