Table 2 The INTACT-intervention (study protocol)
Task | Responsible |
|---|---|
1. Prior to delivery, inform the teams about inclusion status and prepare study documents. | Midwife |
2. Attach the Vacuform mattress to the mother’s legs before placing sterile drapes. Ensure enough space for SSC on the mother’s chest. | OR-circulating nurse / nurse anaesthetist |
3. Prepare sterile syringes for umbilical cord blood samples, and two SteriDrape isolation bags: One for the placenta, and one for the infant (placed on a sterile towel on the mother’s legs) | Scrub nurse |
4. Cover the infant in the sterile plastic bag, with the infant’s legs close to incision site. Beware of obstruction of airways or overstretching the umbilical cord. | Scrub nurse / obstetrician |
5. Start Apgar timer in the moment the infant is born and announce elapsed time 10, 30 and 60Â s after delivery. | OR circulating nurse |
6. Attach NeoBeat on the infant’s chest within 10 s. Stimulate the infant’s back if needed. Communicate HR-readings at 10, 30 and 60 s. | Midwife |
7. Record infant’s first cry/breathing status and HR-readings on the data collection sheet | OR circulating nurse |
8. Obtain arterial and venous blood samples from a pulsating umbilical cord within 40Â s after delivery of the infant. Communicate to time-keeper | Obstetrician |
9. Deliver the placenta into the isolation bag within 60–90 s after delivery of the infant. Await signs of separation, apply gentle cord traction and uterine massage if necessary, communicate to time-keeper | Obstetrician |
10. In the event of severe maternal bleeding needing immediate attention, communicate this to the team and consider abandoning protocol. | Obstetrician |
11. Follow algorithm for newborn resuscitation: If no spontaneous respiration, or HR < 100 and not rising at 30 s after delivery, call out for early cord clamping (or early delivery of the placenta) and abandon protocol. | Midwife/ paediatric registrar |
12. After delivery of the placenta, remove the outer pair of sterile gloves, ensure secure wrapping of infant and placenta, and transfer to the radiant warmer in the adjacent room (after a short welcoming cuddle if the infant is vigorous). Place the placenta next to the infant on the radiant warmer. | Midwife |
13. Deliver Apgar timer and data collection sheet at the radiant warmer | OR circulating nurse |
14. For vigorous infants: monitor heart rate by NeoBeatâ„¢ until cord clamping. Communicate HR-readings every minute, register on data collection sheet | Midwife, NICU nurse/ co-investigator |
15. For infants needing respiratory support: replace NeoBeat with standard ECG-electrodes and pulse-oximetry for further surveillance as long as necessary. | NICU-nurse |
16. Communicate HR-readings, saturation (SpO2) every minute). Record all readings and changes in delivered oxygen fraction (FiO2) on the data collection sheet | NICU-nurse/ Midwife |
17. Clamp the umbilical cord when criteria for PBCC are met, at maximum 10Â min after delivery. Record the time | Midwife |
18. Agree on Apgar scores and duration of respiratory support before the neonatal team leave the room. Measure rectal temperature (within 10–15 min). | Midwife |
19. Vigorous infant: Provide skin-to-skin contact with the mother on the operating table within 15 min after delivery. Use modified leg warmer directly the infant’s skin, add warm towels. Measure axillar temperature at 30–40 min after delivery | Midwife |
20. Infant needing respiratory support after cord clamping: Transfer to the NICU. Record admission temperature. | Neonatal team |
21. Estimate maternal haemorrhage by visual inspection and count of bloodstained compresses. Record result on checklist. | OR-team |