An interventional study of Sustained cord (≥ 180 seconds) resuscitation and Routine (< 60 seconds) cord clamping in Asphyxia Neonatorum and Fetal Hypoxia, sponsored by Region Skane. Recruiting at 12 sites in Sweden. Open to participants aged 37 Weeks to 42 Weeks. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Region Skane · Not applicable, Interventional, and Treatment
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 an uncut umblical cord 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
Study Title
Sustained Cord Circulation at Emergency Cesarean Section (SUCCECS): A Multicenter Stepped-Wedge Cluster Randomized 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 before 72 completed hours of age meeting predefined criteria, or neonatal death before 72 completed hours of age regardless of admission. Predefined criteria include asphyxia at birth, respiratory distress, hypoxic ischemic encephalopathy (HIE) and hypoglycemia.
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.
Sample size: Planning assumptions were a pre-trial incidence of the primary outcome of 18.2%, an anticipated relative risk of 0.85 and a two-sided alpha of 0.05. The expected analyzable sample is approximately 2,200 neonates.
Study duration: inclusion from 8 September 2025 to 31 October 2027; follow-up to 48 months of age.
Outcome definitions and the statistical analysis plan were updated in Protocol version 2.2 and Statistical Analysis Plan version 2.0 (September 2026), before any interim analysis.
106 studies on the registry are indexed under Asphyxia Neonatorum; 19 are open to participants now.
This study's planned enrollment of 2,200 is above the median of 173 across 73 interventional studies indexed under Asphyxia Neonatorum.
Browse Asphyxia Neonatorum studies →Region Skane is the lead sponsor of 386 studies on the registry; 122 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 29, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The neonate will be kept close to the mother with the cord intact. When in need of ventilatory support, the neonatal team will give ventilatory support with an unclamped umbilical cord, following neonatal cardiopulmonary resuscitation guidelines. Cord clamping will be performed after respiration has been established and at the earliest after three minutes and not later than five minutes.
Procedure: Sustained cord (≥ 180 seconds) resuscitation
Management according to standard care, including immediate cord clamping for neonates requiring ventilatory support. In cases where ventilatory support is not necessary, cord clamping will be performed within 60 seconds of birth, adhering to established clinical guidelines for neonatal management.
Procedure: Routine (< 60 seconds) cord clamping
Resuscitation performed in near proximity to the mother with umbilical cord uncut
Also known as: Intact cord resuscitation, Delayed cord clamping
Resuscitation performed at a designated area after umbilical cord is cut
Also known as: Immediate clamping
Composite outcome of admission to neonatal care meeting predefined criteria or neonatal death, before 72 completed hours of age.
Binary composite. Event: (1) admission to neonatal care before 72 completed hours of age with at least one predefined criterion, or (2) death of a liveborn neonate before 72 completed hours of age (days 0-2), regardless of admission. Criteria: asphyxia at birth (Apgar score \<4 at 1 minute, \<4 at 5 minutes or \<6 at 10 minutes; Apgar values are taken from the Swedish Pregnancy Register (SPR); the Swedish Neonatal Quality Register (SNQ) value is used only when the SPR value is missing); respiratory morbidity (ICD-10 P22.0, P22.1, P22.8, P24.0, P25.1 or P29.3B); hypoxic-ischemic encephalopathy grade I-III (P91.6A, P91.6B, P91.6C or P91.6X); hypoglycemia (P70.4A or P70.4B). Admissions and diagnoses from SPR and SNQ; deaths additionally from Statistics Sweden, including deaths after discharge.
Time frame: From birth to 72 completed hours of age (days 0-2)
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.
Time frame: 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.
Time frame: 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.
Time frame: From birth to 72 completed hours of age
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.
Time frame: From birth to 72 completed hours of age
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.
Time frame: From birth to 72 completed hours of age
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
Time frame: One month
Death before discharge from the initial birth hospitalization
All-cause death from birth until discharge from the initial birth hospitalization, without an upper time limit. For neonates transferred between hospitals, vital status is ascertained through SPR and SNQ linkage.
Time frame: From birth until discharge from the initial birth hospitalization, an average of 4 days
Early neonatal death before 168 completed hours of age
Death of a liveborn neonate before 168 completed hours of age (days 0-6).
Time frame: From birth to 168 completed hours of age (days 0-6)
Neonatal outcomes - breathing
After birth (data registered on the resuscitation chart or imported from monitor equipment): Initiation and establishment of breathing (Minutes and seconds)
Time frame: Birth to one hour
Neonatal outcomes - temperature
After birth (data registered on the resuscitation chart, source data sheet or imported from monitor equipment): Temperature (degrees Celsius)
Time frame: Birth to six hours
Neonatal outcomes - interventions
After birth (data registered on the resuscitation chart or imported from monitor equipment): Rate of Interventions (e.g. ventilation, intubation, chest compressions) noted on the resuscitation chart
Time frame: 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
Time frame: 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
Time frame: Birth to 24 hours
Neonatal outcome - hyperbilirubinemia and jaundice
ICD-10 P58.3, P59.8 or P59.9 together with KVÅ procedure code DQ015, recorded in SPR and/or SNQ. Neonates with concurrent hemolytic disease codes P55.0, P55.1, P55.8 or P55.9 are excluded.
Time frame: Birth to seven days
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
Time frame: Birth to one month
Maternal outcomes - maternal death
Maternal death from any cause within 42 days postpartum, ascertained from SPR and medical records.
Time frame: Child's birth until 6 weeks
Maternal outcomes - maternal blood loss
Maternal blood loss (Amount of postpartum bleeding, ml) Severe post-partum hemorrhage (\> 1000 ml and \> 2000 ml)
Time frame: Birth to one month
Maternal outcomes - post-surgery infection
Maternal infection diagnosed within 1 week postpartum (ICD-10 O86.0, O86.1 or O86.8), ascertained from SPR or the medical record.
Time frame: From delivery to 1 week postpartum
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.
Time frame: 12 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.
Time frame: 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.
Time frame: 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.
Time frame: 48 months
Plan to share: No — At present we are not allowed to share anonymized data extracted from Swedish medical health registers.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.