Keeping the umbilical cord intact during resuscitation after emergency cesarean delivery
Official title: Sustained Cord Circulation at Emergency Cesarean Section - a New Concept for Resuscitating Neonates
Run by Region Skane · NCT06540222 · Data updated 2026-11-12
This will test whether keeping the umbilical cord attached for 3–5 minutes during resuscitation helps term babies born by emergency C-section who aren't breathing.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 37 Weeks to 42 Weeks |
| Sex | All |
| Enrollment | 2200 (estimated) |
| Sponsor | Region Skane Academic / other |
| Locations | 12 sites (Gothenburg and 11 other locations) |
| Status | Recruiting |
| Started | September 8, 2025 |
| Main results expected | November 2027 |
| Study ends | November 2031 |
| Registry record updated | October 29, 2026 |
| Trial ID | NCT06540222 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal participants are term (≥37 weeks), singleton newborns delivered by emergency cesarean with epidural/spinal anesthesia whose pediatric team is present and who require resuscitation.
✕Probably not a fit
Preterm infants, babies with major congenital or genetic conditions, deliveries under general anesthesia, or situations where the cord cannot be maintained intact are unlikely to benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter, stepped-wedge cluster randomized trial compares intact-cord resuscitation (keeping the cord attached for ≥180 seconds) to routine early cord clamping (<60 seconds) in term singleton neonates born by emergency cesarean under spinal or epidural anesthesia. Babies who need respiratory support are kept close to the mother with the placenta in situ and receive neonatal resuscitation per Swedish guidelines while the cord remains intact for 3–5 minutes. The primary outcome is a composite of admission to neonatal care for predefined criteria or death before admission within one week; secondary outcomes include short- and long-term neonatal and maternal outcomes and staff and caregiver experiences. The trial is being conducted at multiple Swedish hospitals with a pediatric team present at delivery for eligible infants.
Why it matters
Potential benefit: If successful, keeping the cord intact during resuscitation could reduce neonatal admissions and lower the risk of respiratory problems and hypoxic-ischemic injury.
How similar studies have gone: Observational and feasibility studies have shown promising physiological and short-term outcomes with intact-cord resuscitation, but randomized evidence for non-breathing term infants born by emergency cesarean is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Singleton neonate * Born alive * Gestational age ≥37 weeks * Born by emergency cesarean section, epidural/spinal anesthesia, where the pediatric team was summoned before the start of the cesarean section because of health concerns regarding the neonate. Exclusion Criteria: * Major congenital malformation that may affect resuscitation or outcome measures. * Major genetic disorder that may affect resuscitation or outcome measures. * Condition in the mother or neonate, known before birth, that warrants immediate cord clamping (e.g., placenta accreta, severe maternal coagulation disorder).
Where it's running
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Östra sjukhuset - Sahlgrenska Universitetssjukhuset
Gothenburg, Sweden Recruiting -
Hallands sjukhus, Halmstad
Halmstad, Sweden Recruiting -
Universitetssjukhuset i Linköping
Linköping, Sweden Recruiting -
Skånes Universitetssjukhus
Lund, Sweden Recruiting -
Skånes Universitetssjukhus, Malmö
Malmö, Sweden Recruiting -
Universitetssjukhuset Örebro
Örebro, Sweden Recruiting
Show 6 more locations
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BB Stockholm
Stockholm, Sweden Recruiting -
Danderyds sjukhus
Stockholm, Sweden Recruiting -
Karolinska Universitetssjukhuset, Huddinge
Stockholm, Sweden Recruiting -
Karolinska Universitetssjukhuset, Solna
Stockholm, Sweden Recruiting -
Södersjukhuset - Sachsska barn- och ungdomssjukhuset
Stockholm, Sweden Recruiting -
Norrlands universitetssjukhus
Umeå, Sweden Recruiting
Study contacts
- Principal investigator: Ola Andersson, MD PhD — Region Skåne, Lund University
- Study coordinator: Ola Andersson, MD PhD
- Email: ola.andersson@med.lu.se
- Phone: +46 70-966 41 80
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.