Sustained Cord Circulation at Emergency Cesarean Section
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sustained cord (≥ 180 seconds) resuscitation, Routine (< 60 seconds) cord clamping.
- Who it may be relevant to
- Registry conditions: Asphyxia Neonatorum, Fetal Hypoxia. Basic parameters: 37 Weeks — 42 Weeks · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Sustained Cord Circulation at Emergency Cesarean Section - a New Concept for Resuscitating Neonates
Overview
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
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
Interventions
- Procedure Sustained cord (≥ 180 seconds) resuscitation
Resuscitation performed in near proximity to the mother with umbilical cord uncut - Procedure Routine (< 60 seconds) cord clamping
Resuscitation performed at a designated area after umbilical cord is cut
Primary outcome measures
- Composite outcome of admission to neonatal care for predefined criteria and death before admission. [Time frame: At one hour after birth]
Secondary outcome measures (7)
- Apgar score at 5 min [Time frame: 5 minutes]
- Apgar score at 10 min [Time frame: 10 minutes]
- Respiratory distress as a diagnosis after birth [Time frame: One week after birth]
- Hypoxic-ischemic encephalopathy as a diagnosis after birth [Time frame: One week after birth]
- Hypoglycemia as a diagnosis after birth [Time frame: One week after birth]
- Duration of neonatal care [Time frame: One month]
- Death after birth but before admission to neonatal unit [Time frame: One hour after birth]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Sweden · 12 centers
- Östra sjukhuset - Sahlgrenska Universitetssjukhuset — Gothenburg
- Hallands sjukhus, Halmstad — Halmstad
- Universitetssjukhuset i Linköping — Linköping
- Skånes Universitetssjukhus — Lund
- Skånes Universitetssjukhus, Malmö — Malmö
- Universitetssjukhuset Örebro — Örebro
- BB Stockholm — Stockholm
- Danderyds sjukhus — Stockholm
- … and 4 more centers
Publications
- 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. PMID 40479951
- 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. PMID 37767916
Identifiers
NCT: NCT06540222 · SUCCECS · Dnr 2024-00276-01