Extra-uterine placental transfusion and intact-cord stabilisation of moderately preterm to term infants in caesarean deliveries - A feasibility study with historical control (INTACT-2)

Background: Although delayed umbilical cord clamping (DCC) is universally recommended, implementation has been difficult in caesarean deliveries. The study objective was to test if extra-uterine placental transfusion (delivering the placenta before cord clamping) to facilitate intact-cord stabilisation could be a feasible and safe alternative to DCC (≥ 1 min) for moderately preterm to term infants with caesarean delivery in regional anaesthesia and their mothers. Methods: This feasibility study included infants with GA 32⁰ to 42³ weeks with planned or emergency caesarean delivery. Primary outcome was intervention compliance. Safety outcomes were prevalence of blood loss ≥1000 ml or postoperative wound infection in mothers, and prevalence of early cord clamping (ECC), low 5-min Apgar scores and hypothermia in infants. Results: We included 123 mother-infant pairs in the intervention group and 158 in the historical control group. The intervention was successfully completed in 121 of 123 cases. There were no statistically significant differences in maternal outcomes. Significantly less infants in the intervention group had ECC before 60 s (OR 0.07, CI (0.01–0.51), P = 0.009) and 5-min Apgar scores <7 (P = 0.003) compared to historical controls. There was no significant difference in infant hypothermia. Conclusion: Extra-uterine placental transfusion may be a reasonable alternative to DCC for term and near term preterm infants with caesarean delivery in regional anaesthesia. The intervention may be especially useful in low-income birth settings with high prevalence of iron deficiency/anaemia and no mobile resuscitation equipment.