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NCT Number: NCT06540222

Sustained Cord Circulation at Emergency Cesarean Section

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

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Key information

Conditions

Asphyxia Neonatorum Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Fetal Hypoxia Hypoxia Infant, Newborn, Diseases Pathological Conditions, Signs and Symptoms Pregnancy Complications Signs and Symptoms Signs and Symptoms, Respiratory Urogenital Diseases

Age range

37 week–42 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Östra sjukhuset - Sahlgrenska Universitetssjukhuset, Gothenburg, Sweden

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Singleton neonate
  • Born alive
  • Gestational age ≥37 weeks
  • Born by emergency cesarean section, epidural/spinal anesthesia, where the pediatric/neonatal team has been called for to attend.

Exclusion criteria

  • Major congenital malformation that may affect resuscitation or outcome measures.
  • Major genetic disorder that may affect resuscitation or outcome measures.

Treatment and study plan

Sustained cord (≥ 180 seconds) resuscitation

Procedure

Resuscitation performed in near proximity to the mother with umbilical cord uncut

Other names: Intact cord resuscitation, Delayed cord clamping

Routine (< 60 seconds) cord clamping

Procedure

Resuscitation performed at a designated area after umbilical cord is cut

Other names: Immediate clamping

Primary outcomes

  1. Composite outcome of admission to neonatal care for predefined criteria and death before admission.

    Time frame: At one hour after birth

    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.

Secondary outcomes

  1. Apgar score at 5 min

    Time frame: 5 minutes

    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.

  2. Apgar score at 10 min

    Time frame: 10 minutes

    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.

  3. Respiratory distress as a diagnosis after birth

    Time frame: One week 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.

  4. Hypoxic-ischemic encephalopathy as a diagnosis after birth

    Time frame: One week 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.

  5. Hypoglycemia as a diagnosis after birth

    Time frame: One week after birth

    Having the at least one of the following diagnosis in the Swedish neonatal quality registry: Hypoglycemia, P 70.4A, or B.

  6. Duration of neonatal care

    Time frame: One month

    Duration of neonatal care as noted in the Swedish pregnancy register and Swedish neonatal quality registry: Aggregated as day (continuous) and ≥ 2 days, dichotomous

  7. Death after birth but before admission to neonatal unit

    Time frame: One hour after birth

    Noted as dead after birth in the Swedish pregnancy register

Other outcomes

  1. Neonatal outcomes - breathing

    Time frame: Birth to one hour

    After birth (data registered on the resuscitation chart or imported from monitor equipment):

    Initiation and establishment of breathing (Minutes and seconds)

  2. Neonatal outcomes - temperature

    Time frame: Birth to six hours

    After birth (data registered on the resuscitation chart, source data sheet or imported from monitor equipment):

    Temperature (degrees Celsius)

  3. Neonatal outcomes - interventions

    Time frame: Birth to one hour

    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

  4. Neonatal outcomes - heart rate

    Time frame: Birth to 24 hours

    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

  5. Neonatal outcomes - oxygen saturation

    Time frame: Birth to 24 hours

    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

  6. Neonatal outcome - hyperbilirubinemia and jaundice

    Time frame: Birth to seven days

    Neonatal jaundice requiring phototherapy, (diagnoses reported in SPR and/or SNQ). P58.3, P59.8 (immunizations and hemolytic disorders will be excluded in this analysis)

  7. Neonatal morbidity

    Time frame: Birth to one month

    During neonatal care (diagnosis from registries):

    Neonatal seizures Neonatal infection Neonatal jaundice Intracranial hemorrhage

    Unit of measure: Diagnosis occurring in Swedish Neonatal Quality registry

  8. Maternal outcomes - maternal death

    Time frame: Child's birth until 6 weeks

    Maternal death, collected from SPR (O 95, O95.9, O97)

  9. Maternal outcomes - maternal blood loss

    Time frame: Birth to one month

    Maternal blood loss (Amount of postpartum bleeding, ml) Severe post-partum hemorrhage (> 1000 ml and > 2000 ml)

  10. Maternal outcomes - post-surgery infection

    Time frame: Birth to one month

    Maternal post-surgery infection

    Unit of measure: Diagnosis occurring in Swedish Pregnancy registry

  11. Development assessed by ASQ at 12 months of age

    Time frame: 12 months

    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. Development

    Time frame: 24 months

    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.

  13. Development

    Time frame: 36 months

    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.

  14. Development

    Time frame: 48 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jenny Svedenkrans, MD PhD

CONTACT

[email protected]

‭+46 72-469 86 60

Ola Andersson, MD PhD

CONTACT

[email protected]

‭+46 70-966 41 80

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Collaborators

  • Region Stockholm

Registry information

Official study title

Sustained Cord Circulation at Emergency Cesarean Section - a New Concept for Resuscitating Neonates

Acronym: SUCCECS

Important dates

Study start
2025
Primary completion
2027
Study completion
2031
First posted
Aug 6, 2024
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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