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| ID | Type | Description | Link |
|---|---|---|---|
| Dnr 2024-00276-01 | Other Identifier | The Swedish Ethical Review Authority |
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| Name | Class |
|---|---|
| Region Stockholm | OTHER_GOV |
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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 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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intact cord | Experimental | 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. |
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| Standard care | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sustained cord (≥ 180 seconds) resuscitation | Procedure | Resuscitation performed in near proximity to the mother with umbilical cord uncut |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ola Andersson, MD PhD | Contact | +46 70-966 41 80 | ola.andersson@med.lu.se | |
| Jenny Svedenkrans, MD PhD | Contact | +46 72-469 86 60 | jenny.svedenkrans@ki.se |
| Name | Affiliation | Role |
|---|---|---|
| Ola Andersson, MD PhD | Region Skåne, Lund University | Principal Investigator |
| Jenny Svedenkrans, MD PhD | Karolinska University Hospital, Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Östra sjukhuset - Sahlgrenska Universitetssjukhuset | Recruiting | Gothenburg | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40479951 | Background | Ekelof K, Saether E, Andersson O, Svedenkrans J, Linden K. pre-SUCCECS: Lessons learned from implementing resuscitation and stabilisation with an intact cord during caesarean sections - Focus group discussions with implementation teams. Sex Reprod Healthc. 2025 Sep;45:101114. doi: 10.1016/j.srhc.2025.101114. Epub 2025 May 26. | |
| 37767916 |
| Label | URL |
|---|---|
| Homepage of the SUCCECS study (in Swedish) | View source |
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At present we are not allowed to share anonymized data extracted from Swedish medical health registers.
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| ID | Term |
|---|---|
| D001238 | Asphyxia Neonatorum |
| D005311 | Fetal Hypoxia |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D005315 | Fetal Diseases |
| D011248 | Pregnancy Complications |
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| ID | Term |
|---|---|
| D012151 | Resuscitation |
| D000087526 | Umbilical Cord Clamping |
| ID | Term |
|---|---|
| D004638 | Emergency Treatment |
| D013812 | Therapeutics |
| D036861 | Delivery, Obstetric |
| D013513 | Obstetric Surgical Procedures |
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Multicenter, stepped-wedge cluster randomized trial
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| Routine (< 60 seconds) cord clamping | Procedure | Resuscitation performed at a designated area after umbilical cord is cut |
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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 |
After birth (data registered on the resuscitation chart, source data sheet 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): Rate of 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 outcome - hyperbilirubinemia and jaundice | 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) | 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 | Birth to one month |
| Maternal outcomes - maternal death | Maternal death, collected from SPR (O 95, O95.9, O97) | 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) | Birth to one month |
| Maternal outcomes - post-surgery infection | Maternal post-surgery infection Unit of measure: Diagnosis occurring in Swedish Pregnancy registry | Birth to one month |
| 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 |
| 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 |
| Hallands sjukhus, Halmstad | Recruiting | Halmstad | Sweden |
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| Universitetssjukhuset i Linköping | Recruiting | Linköping | Sweden |
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| Skånes Universitetssjukhus | Recruiting | Lund | Sweden |
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| Skånes Universitetssjukhus, Malmö | Recruiting | Malmö | Sweden |
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| Universitetssjukhuset Örebro | Recruiting | Örebro | Sweden |
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| BB Stockholm | Recruiting | Stockholm | Sweden |
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| Danderyds sjukhus | Recruiting | Stockholm | Sweden |
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| Karolinska Universitetssjukhuset, Huddinge | Recruiting | Stockholm | Sweden |
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| Karolinska Universitetssjukhuset, Solna | Recruiting | Stockholm | Sweden |
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| Södersjukhuset - Sachsska barn- och ungdomssjukhuset | Recruiting | Stockholm | Sweden |
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| Norrlands universitetssjukhus | Recruiting | Umeå | Sweden |
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| Alikhani VS, Thies-Lagergren L, Svedenkrans J, Elfvin A, Bolk J, Andersson O. Stabilisation and resuscitation with intact cord circulation is feasible using a wide variety of approaches; a scoping review. Acta Paediatr. 2023 Dec;112(12):2468-2477. doi: 10.1111/apa.16985. Epub 2023 Sep 28. |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000860 | Hypoxia |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013514 |
| Surgical Procedures, Operative |