Asphyxia NeonatorumSUCCECSNCT06540222
Sustained Cord Circulation at Emergency Cesarean Section
A study testing Sustained cord (≥ 180 seconds) resuscitation and Routine (< 60 seconds) cord clamping in people with Asphyxia Neonatorum and Fetal Hypoxia, run by Region Skane at 12 sites in Sweden.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 37 to 42 weeks
- Conditions the study is for
- Asphyxia Neonatorum, Fetal Hypoxia
- What is being tested?
- Sustained cord (≥ 180 seconds) resuscitation and Routine (< 60 seconds) cord clamping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,200 participants
- Where
- 12 sitesSweden
- Study dates
- 8 Sep 2025to Nov 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 37 to 42 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Major congenital malformation that may affect resuscitation or outcome measures.
- Major genetic disorder that may affect resuscitation or outcome measures.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
Sweden12 sites, 12 recruiting
- Recruiting
Östra sjukhuset - Sahlgrenska Universitetssjukhuset
Gothenburg
Anders Elfvin, +46 31-342 10 00, SUCCECS@med.lu.se
Verena Sengpiel
- Recruiting
Hallands sjukhus, Halmstad
Halmstad
Anna Kasemo, +4635131000, SUCCECS@med.lu.se
Anna Kasemo
- Recruiting
Universitetssjukhuset i Linköping
Linköping
Thomas Abrahamsson
Sara Carlhäll
- Recruiting
Skånes Universitetssjukhus
Lund
Elisabeth Olhager, 046-171000, SUCCECS@med.lu.se
Elisabeth Olhager
- Recruiting
Skånes Universitetssjukhus, Malmö
Malmö
Elisabeth Olhager, 040-331000, SUCCECS@med.lu.se
Elisabeth Olhager
- Recruiting
Universitetssjukhuset Örebro
Örebro
Miriam Pettersson
Karin Hilden
- Recruiting
BB Stockholm
Stockholm
Anna Claréus
Katarina Remaeus
- Recruiting
Danderyds sjukhus
Stockholm
Anna Claréus
Sophia Brismar Wendel
- Recruiting
Karolinska Universitetssjukhuset, Huddinge
Stockholm
Jenny Svedenkrans
Johanna Andersson
- Recruiting
Karolinska Universitetssjukhuset, Solna
Stockholm
Malin Kjellberg
Anna Sand
- Recruiting
Södersjukhuset - Sachsska barn- och ungdomssjukhuset
Stockholm
Jenny Bolk
Julia Savchenko
- Recruiting
Norrlands universitetssjukhus
Umeå
Magnus Domellöf
Linnea Åström
About this study
Official title: 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
Read the 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
- Conditions
- Asphyxia Neonatorum, Fetal Hypoxia
- Being tested
- Sustained cord (≥ 180 seconds) resuscitation, Routine (< 60 seconds) cord clamping
- Keywords
- Emergency cesarean section, Management umbilical cord, intact cord resuscitation
- Medical subject headings
- Asphyxia Neonatorum, Fetal Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sustained cord (≥ 180 seconds) resuscitationProcedure or surgery
Also called Intact cord resuscitation, Delayed cord clamping
Resuscitation performed in near proximity to the mother with umbilical cord uncut
Routine (< 60 seconds) cord clampingProcedure or surgery
Also called Immediate clamping
Resuscitation performed at a designated area after umbilical cord is cut
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Sustained cord (≥ 180 seconds) resuscitation |
| 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. Receives: Procedure: Routine (< 60 seconds) cord clamping |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At one hour after birth
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: One month
Death after birth but before admission to neonatal unit
Noted as dead after birth in the Swedish pregnancy register
Measured: One hour after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start8 Sep 2025
- Primary completionNov 2027 (estimated)
- Study completionNov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Asphyxia NeonatorumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, stepped-wedge cluster randomized trial
- Masking
- None (open label)
- Enrolment
- 2,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Sponsor
- Investigators
- Ola Andersson, MD PhD, Principal investigator, Region Skåne, Lund UniversityJenny Svedenkrans, MD PhD, Principal investigator, Karolinska University Hospital, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06540222
- Sponsor's protocol ID
- SUCCECS
- Other IDs
- Dnr 2024-00276-01
- Acronym
- SUCCECS
- Status last verified
- Sep 2025
- First submitted
- 3 Jul 2024
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At present we are not allowed to share anonymized data extracted from Swedish medical health registers.
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.
PubMed 40479951Alikhani 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.
PubMed 37767916
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustained Cord Circulation at Emergency Cesarean Section - a New Concept for Resuscitating Neonates
- ClinicalTrials.gov ID
- NCT06540222
- Acronym / sponsor ID
- SUCCECS / SUCCECS
- Conditions
- Asphyxia Neonatorum, Fetal Hypoxia
- Keywords
- Emergency cesarean section, Management umbilical cord, intact cord resuscitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,200 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- 8 Sep 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2031 (estimated)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter, stepped-wedge cluster randomized trial
| Arm | Type | Receives |
|---|---|---|
| Intact cord | Experimental | Procedure: Sustained cord (≥ 180 seconds) resuscitationThe 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. |
| Standard care | Active comparator | Procedure: Routine (< 60 seconds) cord clampingManagement 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. |
Who may qualify
- Ages
- 37 to 42 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Major congenital malformation that may affect resuscitation or outcome measures.
- Major genetic disorder that may affect resuscitation or outcome measures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sustained cord (≥ 180 seconds) resuscitationAlso: Intact cord resuscitation, Delayed cord clampingResuscitation performed in near proximity to the mother with umbilical cord uncut | Procedure or surgery | Intact cord |
| Routine (< 60 seconds) cord clampingAlso: Immediate clampingResuscitation performed at a designated area after umbilical cord is cut | Procedure or surgery | Standard care |
Primary outcome
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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Background: PubMed 40479951Ekelof 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.
- Background: PubMed 37767916Alikhani 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.
- Homepage of the SUCCECS study (in Swedish)Link provided by the sponsor.
- Individual participant dataSharing planned: No. At present we are not allowed to share anonymized data extracted from Swedish medical health registers.
Related trials for Asphyxia Neonatorum
Not yet recruiting
Levetiracetam as an Adjuvant Therapy to Hypothermia in Neonatal Asphyxia
Hypoxic Ischemic Encephalopathy of Newborn, Neuro-protection
Active, not recruiting
Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants
IVH- Intraventricular Hemorrhage, Extreme Prematurity
Not yet recruiting
Magnesium Sulphate for Neonatal Asphyxia and Length of Hospital Stay
Duration of Hospitalization, Neonatal Mortality Rate
RecruitingPhase 2
Treatment of Neonatal Encephalopathy With Oral Sildenafil Suspension to Repair Brain Injury Secondary to Birth Asphyxia
Neonatal Encephalopathy
Not yet recruitingObservational study
Evaluation of Neonatal Acute Hypoxia at Delivery Using Fetal Physiology and Eucapnic pH Assessment
Neonatal Acidemia and Hypoxia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ola Andersson, MD PhD principal investigator
Region Skåne, Lund University
Jenny Svedenkrans, MD PhD principal investigator
Karolinska University Hospital, Karolinska Institutet
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sustained cord (≥ 180 seconds) resuscitation and Routine (< 60 seconds) cord clamping in people with Asphyxia Neonatorum and Fetal Hypoxia, run by Region Skane at 12 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ola Andersson, MD PhD (+46 70-966 41 80, ola.andersson@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite outcome of admission to neonatal care for predefined criteria and death before admission. (time frame: At one hour after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06540222, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.