Extra-uterine placental transfusion and intact-cord stabilisation of infants in caesarean sections: An intervention development and pilot-study (INTACT-1)

Abstract

Background: Keeping the umbilical cord intact the first minutes after delivery is beneficial for both term and preterm infants. However, this may be challenging in caesarean sections (CS) due to lack of mobile resuscitation equipment, maintenance of sterility or concern for excessive maternal blood loss. The objective of this study was to develop and pilot-test extra-uterine placental transfusion and intact-cord stabilisation of infants in CS. Methods: The intervention development process (phase 1) covered: A) placenta delivery without cord clamping, B) intact-cord stabilisation of the infant and C) physiology-based cord clamping. Different scenarios were tested through in-situ simulation and adjusted through multiple feedback rounds. The involved staff were trained prior to pilot-testing (phase 2). Women having a CS in regional anaesthesia, expecting a term or near-term singleton infant were included in the pilot-study after written consent. Primary outcome was the proportion of successfully completed interventions. For assessment of safety, maternal estimated intraoperative blood loss, infant 5-minute Apgar scores and infant rectal temperature during stabilisation were compared to pre-defined accept criteria. Dry-electrode ECG (NeoBeat™) was used for early detection of infant heartrate. Any respiratory support was registered. Early skin-to-skin contact between mother and infant was attempted for vigorous infants. Results: A detailed intervention protocol was developed and tested. Twenty-nine mother-infant-dyads were included in the pilot study. Gestational age ranged from 37 to 42 weeks. The intervention was successfully completed in 90 % of the cases, of which 31 % were planned CS. Median (SD) infant heart rates at one and five minutes were 159 (32) and 168 (21) beats per minute respectively. Eight infants (28%) had intact-cord respiratory support. One infant (3.5%) had a 5-minute Apgar score < 7 and three infants (10%) had rectal temperatures below 36.5°C during the first 10-15 minutes after birth. Three mothers (10%) had estimated intraoperative blood loss > 1000 ml Conclusion: Extra-uterine placental transfusion to facilitate intact-cord stabilisation and physiology-based cord clamping for infants delivered by CS was feasible and safe according to predefined accept criteria. Further testing of this complex intervention in larger, comparative studies is warranted. Trial registration: Regional Committee for Medical Research Ethics Central Norway (REK-Midt), #399101