Sustained Cord Circulation at Emergency Cesarean Section
NCT ID: NCT06540222
Last Updated: 2025-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
2200 participants
INTERVENTIONAL
2025-09-08
2031-11-30
Brief Summary
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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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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Sustained cord (≥ 180 seconds) resuscitation
Resuscitation performed in near proximity to the mother with umbilical cord uncut
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.
Routine (< 60 seconds) cord clamping
Resuscitation performed at a designated area after umbilical cord is cut
Interventions
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Sustained cord (≥ 180 seconds) resuscitation
Resuscitation performed in near proximity to the mother with umbilical cord uncut
Routine (< 60 seconds) cord clamping
Resuscitation performed at a designated area after umbilical cord is cut
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 genetic disorder that may affect resuscitation or outcome measures.
37 Weeks
42 Weeks
ALL
No
Sponsors
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Region Stockholm
OTHER_GOV
Region Skane
OTHER
Responsible Party
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Principal Investigators
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Ola Andersson, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Region Skåne, Lund University
Jenny Svedenkrans, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska University Hospital, Karolinska Institutet
Locations
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Östra sjukhuset - Sahlgrenska Universitetssjukhuset
Gothenburg, , Sweden
Hallands sjukhus, Halmstad
Halmstad, , Sweden
Universitetssjukhuset i Linköping
Linköping, , Sweden
Skånes Universitetssjukhus
Lund, , Sweden
Skånes Universitetssjukhus, Malmö
Malmo, , Sweden
Universitetssjukhuset Örebro
Örebro, , Sweden
BB Stockholm
Stockholm, , Sweden
Danderyds sjukhus
Stockholm, , Sweden
Karolinska Universitetssjukhuset, Huddinge
Stockholm, , Sweden
Karolinska Universitetssjukhuset, Solna
Stockholm, , Sweden
Södersjukhuset - Sachsska barn- och ungdomssjukhuset
Stockholm, , Sweden
Norrlands universitetssjukhus
Umeå, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Verena Sengpiel
Role: backup
References
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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.
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.
Related Links
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Homepage of the SUCCECS study (in Swedish)
Other Identifiers
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Dnr 2024-00276-01
Identifier Type: OTHER
Identifier Source: secondary_id
SUCCECS
Identifier Type: -
Identifier Source: org_study_id
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