Overview
The INTACT-2 feasibility study, conducted by Elisabeth Saether and team in Ålesund, Norway, examines a new approach designed to preserve the benefits of delayed cord clamping (DCC) in situations where it is often not achievable, particularly during caesarean deliveries. The intervention combines extra-uterine placental transfusion with intact-cord stabilisation (ICS) to support physiological neonatal transition while allowing early respiratory assistance when needed.
Clinical Background
Delayed/Optimal cord clamping is recognised for improving neonatal cardiovascular stability and iron stores. However, infants who require the most immediate support are often those who undergo early cord clamping, creating what is known as the cord-clamping paradox: infants who might benefit the most from sustained placental circulation are the ones most frequently deprived of it.
Caesarean deliveries pose additional challenges for DCC due to surgical constraints and the need for rapid assessment. Mobile resuscitation trolleys exist to support intact-cord stabilisation, but they are costly, difficult to manoeuvre, and do not fully resolve issues such as timely respiratory support, reliable heart-rate monitoring, prevention of neonatal hypothermia, and coordinated teamwork in a busy operating theatre.
Innovation: Extra-Uterine Placental Transfusion and ICS
When standard DCC is not feasible, the INTACT-2 protocol explores delivering the placenta before cord clamping to maintain blood flow to the newborn. If required, the infant can also be transferred to a resuscitaire while still attached to the placenta, allowing stabilisation with an intact cord. This method aims to preserve the physiological benefits of delayed cord separation while meeting the clinical need for early respiratory intervention.
Study Results
Feasibility and Safety
The intervention was completed successfully in 121 of 123 cases, showing strong feasibility during caesarean births under regional anaesthesia. No significant differences in maternal outcomes were observed between groups, supporting the safety of this approach.
Neonatal Outcomes
Compared with historical controls:
• Fewer infants experienced early cord clamping before 60 seconds
OR 0.07, CI 0.01–0.51, P = 0.009
• Fewer infants had 5-minute Apgar scores below 7
P = 0.003
• There was no significant difference in rates of neonatal hypothermia
These findings suggest that maintaining umbilical circulation during stabilisation can support improved early transition without adding clinical risk.
Implications for Global Health
This technique may offer an effective alternative to delayed cord clamping for term and moderately preterm infants delivered by caesarean section. It may be especially valuable in settings where mobile intact-cord resuscitation equipment is unavailable or impractical, and in regions with high rates of iron deficiency or neonatal anaemia. The approach is simple, adaptable, and requires minimal additional equipment, making it suitable for both high-resource and low-resource birth environments.
Conclusion
The INTACT-2 study demonstrates that extra-uterine placental transfusion with intact-cord stabilisation is a feasible and clinically promising method when delayed cord clamping cannot be performed during caesarean delivery. By reducing early cord clamping and improving early Apgar scores without affecting maternal or neonatal safety, this approach offers a practical solution to the cord-clamping paradox and may support better neonatal outcomes across diverse clinical settings.
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