Preliminary efficacy, feasibility and safety of intra-umbilical oxytocin to reduce the time to placental delivery at caesarean section: an exploratory randomized trial

Abstract

Background: Delayed placental separation either after vaginal birth or caesarean birth is an important cause of postpartum haemorrhage, among other causes such as uterine atony. Intra-umbilical oxytocin has been shown to reduce the time to placental delivery after vaginal birth. However, the efficacy of intra-umbilical oxytocin to reduce the time to placental delivery following caesarean section birth is not known. Objectives: To explore the preliminary efficacy, feasibility and safety of intra-umbilical oxytocin to reduce the time to placental delivery at caesarean section. Methods: A double-blind, placebo-controlled, exploratory randomized clinical trial was conducted at a tertiary hospital in the Eastern Cape Province, South Africa. A total of 66 women undergoing elective caesarean section were enrolled in the study and randomized into oxytocin group (n = 33) receiving an intra-umbilical infusion of 20 units of oxytocin in 30ml saline, and placebo group (n = 33) receiving an intra-umbilical infusion of 30ml saline. Data were analysed using Epi Info and RevMan software. Preliminary efficacy was assessed by examining the time elapsed from birth of the baby to complete delivery of the placenta; blood loss more than 500 ml; the need for manual removal of the placenta; and the completeness of the placenta. Feasibility was determined by observing the successful insertion of the catheter and injection of the solution. Safety was evaluated by investigating adverse effects of the procedure. Results: Four women (12%) in the placebo group had a delayed placental delivery compared to one (3%) in the oxytocin group. The mean time from birth to placental delivery was 159 (SD 61) seconds in the placebo group and 143 (SD 45) seconds in the oxytocin group. There was no statistically significant difference between the two groups. Feasibility of the procedure was confirmed by successful insertion of the catheter and injection of the majority of the solution in all 66 cases. No adverse effects of the procedure were identified. Conclusion: Administration of intra-umbilical oxytocin is feasible, safe and has potential to reduce the time of placental delivery at caesarean section. Further studies involving larger sample sizes are justified. Keywords: Caesarean section; intra-umbilical oxytocin; postpartum haemorrhage.