Sustained Cord Circulation at Emergency Cesarean Section (SUCCECS)

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

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 Overview

• Status: Recruiting
• Conditions: Asphyxia Neonatorum; Fetal Hypoxia
• Intervention / Treatment: Procedure: Sustained cord (≥ 180 seconds) resuscitation; Procedure: Routine (< 60 seconds) cord clamping

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 2200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ola Andersson, MD PhD; Phone Number: ‭+46 70-966 41 80; Email: ola.andersson@med.lu.se
• Study Contact Backup: Name: Jenny Svedenkrans, MD PhD; Phone Number: ‭+46 72-469 86 60; Email: jenny.svedenkrans@ki.se

Study Locations

• Sweden
  • Gothenburg, Sweden
    • Recruiting
    • Östra sjukhuset - Sahlgrenska Universitetssjukhuset
    • Contact: Anders Elfvin; Phone Number: +46 31-342 10 00; Email: SUCCECS@med.lu.se
    • Contact: Verena Sengpiel
    • Principal Investigator: Anders Elfvin
    • Principal Investigator: Verena Sengpiel
  • Halmstad, Sweden
    • Recruiting
    • Hallands sjukhus, Halmstad
    • Contact: Anna Kasemo; Phone Number: +4635131000; Email: SUCCECS@med.lu.se
    • Principal Investigator: Anna Kasemo
    • Principal Investigator: Sofia Stålnacke
  • Linköping, Sweden
    • Recruiting
    • Universitetssjukhuset i Linköping
    • Principal Investigator: Thomas Abrahamsson
    • Principal Investigator: Sara Carlhäll
  • Lund, Sweden
    • Recruiting
    • Skanes universitetssjukhus
    • Contact: Elisabeth Olhager; Phone Number: 046-171000; Email: SUCCECS@med.lu.se
    • Principal Investigator: Elisabeth Olhager
    • Principal Investigator: Anna Bonnevier
  • Malmo, Sweden
    • Recruiting
    • Skånes Universitetssjukhus, Malmö
    • Principal Investigator: Elisabeth Olhager
    • Contact: Elisabeth Olhager; Phone Number: 040-331000; Email: SUCCECS@med.lu.se
    • Principal Investigator: Gisela Rickle
  • Stockholm, Sweden
    • Recruiting
    • Karolinska Universitetssjukhuset, Huddinge
    • Principal Investigator: Jenny Svedenkrans
    • Principal Investigator: Johanna Andersson
  • Stockholm, Sweden
    • Recruiting
    • Danderyds Sjukhus
    • Principal Investigator: Anna Claréus
    • Principal Investigator: Sophia Brismar Wendel
  • Stockholm, Sweden
    • Recruiting
    • BB Stockholm
    • Principal Investigator: Anna Claréus
    • Principal Investigator: Katarina Remaeus
  • Stockholm, Sweden
    • Recruiting
    • Karolinska Universitetssjukhuset, Solna
    • Principal Investigator: Malin Kjellberg
    • Principal Investigator: Anna Sand
  • Stockholm, Sweden
    • Recruiting
    • Södersjukhuset - Sachsska barn- och ungdomssjukhuset
    • Principal Investigator: Jenny Bolk
    • Principal Investigator: Julia Savchenko
  • Umeå, Sweden
    • Recruiting
    • Norrlands Universitetssjukhus
    • Principal Investigator: Magnus Domellöf
    • Principal Investigator: Linnea Åström
  • Örebro, Sweden
    • Recruiting
    • Universitetssjukhuset Örebro
    • Principal Investigator: Miriam Pettersson
    • Principal Investigator: Karin Hilden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard care; 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 at a designated area after umbilical cord is cut; Other Names: Immediate clamping
Experimental: Intact cord; 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; Resuscitation performed in near proximity to the mother with umbilical cord uncut; Other Names: Intact cord resuscitation; Delayed cord clamping

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 - 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
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
Neonatal outcomes - temperature	After birth (data registered on the resuscitation chart, source data sheet or imported from monitor equipment): Temperature (degrees Celsius)	Birth to six 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
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
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

Collaborators and Investigators

• Sponsor: Region Skane
• Collaborators: Region Stockholm
• Investigators: Principal Investigator: Ola Andersson, MD PhD, Region Skane, Lund University; Principal Investigator: Jenny Svedenkrans, MD PhD, Karolinska University Hospital, Karolinska Institutet

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Homepage of the SUCCECS study (in Swedish)

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2031

Study Registration Dates

• First Submitted: July 3, 2024
• First Submitted That Met QC Criteria: August 1, 2024
• First Posted (Actual): August 6, 2024

Study Record Updates

• Last Update Posted (Actual): September 22, 2025
• Last Update Submitted That Met QC Criteria: September 17, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Emergency cesarean section; Management umbilical cord; intact cord resuscitation
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Infant, Newborn, Diseases; Fetal Diseases; Signs and Symptoms, Respiratory; Hypoxia; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Asphyxia Neonatorum; Fetal Hypoxia; Therapeutics; Surgical Procedures, Operative; Emergency Treatment; Delivery, Obstetric; Obstetric Surgical Procedures; Resuscitation; Umbilical Cord Clamping
• Other Study ID Numbers: SUCCECS; Dnr 2024-00276-01 (Other Identifier: The Swedish Ethical Review Authority)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: At present we are not allowed to share anonymized data extracted from Swedish medical health registers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No