A Randomized Controlled Trial to Assess Prophylactic Methylergonovine in Patients Undergoing an Intrapartum Cesarean Section

Abstract

Objective: To evaluate whether the administration of prophylactic methylergonovine in addition to oxytocin in laboring patients undergoing an intrapartum cesarean section reduces the needs for additional uterotonic agents. Study Design: This was a single center randomized controlled trial of laboring patients undergoing an intrapartum cesarean section. Patients were randomized 1:1 to receive either intravenous oxytocin 300 mU per minute plus 1 ml of intramuscular normal saline or intravenous oxytocin 300 mU per minute plus 0.2 mg (1ml) of intramuscular methylergonovine. The primary outcome was the need for additional uterotonic agents. To detect a 2-fold decrease in the need for additional uterotonics (42% vs 21%) with a 2-sided type 1 error of 5% and power of 80%, a sample size of 76 patients per group was estimated. Results: From June 2019 to February 2021, 160 patients were randomized - 80 were assigned to prophylactic methylergonovine plus oxytocin, 80 were assigned to oxytocin alone. Patients who received prophylactic methylergonovine required significantly less additional uterotonic agents as compared to participants who received oxytocin alone (20% vs 55%, RR 0.36, 95% CI 0.22 - 0.59). Comparing secondary outcomes between groups, participants receiving methylergonovine were more likely to have an improvement in uterine tone (80% vs 41.2%, RR 1.94, 95% CI 1.46 - 2.56), a lower incidence of postpartum hemorrhage (35% vs 58.8%, RR 0.6, 95% CI 0.42 - 0.85) decreased need for a blood transfusion (5% vs 22.5%, RR 0.22, 95% CI 0.08 - 0.63), and lower mean quantitative blood loss (996 ml vs 1315 ml, P = 0.004). Conclusion: The administration of prophylactic methylergonovine in addition to oxytocin in laboring patients undergoing an intrapartum cesarean section reduces the needs for additional uterotonic agents. Validity of the conclusion is supported by results for the secondary endpoints. [Formula presented] [Formula presented]