Keeping the umbilical cord intact during resuscitation after emergency cesarean delivery
Sustained Cord Circulation at Emergency Cesarean Section - a New Concept for Resuscitating Neonates
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2200 (estimated) |
| Ages | 37 Weeks to 42 Weeks |
| Sex | All |
| Sponsor | Region Skane Academic / other |
| Locations | 12 sites (Gothenburg and 11 other locations) |
| Trial ID | NCT06540222 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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/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.
Where this trial is running
Gothenburg and 11 other locations
- 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)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.