Vaginal misoprostol before elective cesarean section for preventing neonatal respiratory distress: a randomized controlled trial
Objective: The current study aims to evaluate the efficacy of vaginal misoprostol before elective cesarean section (ECS) for preventing the occurrence of neonatal respiratory distress (RD).
Materials and Methods: A randomized controlled trial (NCT03239327) was carried out in a tertiary-care university-affiliated hospital between June 2016 and August 2017. All eligible pregnant women scheduled for ECS were randomly allocated in a 1:1 ratio to two groups. One group, the Misoprostol group, received a misoprostol 50 mcg vaginal tablet 60 minutes before ECS while the other, the Control group, received no drugs before ECS. The primary outcome was the rate of neonatal RD among the study groups.
Results: The study included 146 women in each arm, with no significant difference between the baseline characteristics of members in each group. Primary outcomes resulted in 22 (15.1%) newborns in the misoprostol group having RD at birth versus 44 (30.1%) newborns with RD in the control (P =0.02). No differences were found between the groups regarding the need for neonatal intensive care unit (NICU) admission (P =0.61), duration of NICU stay (P =0.08) and neonatal mortality rate (P =0.73).
Conclusion: Prophylactic vaginal misoprostol at a dose of 50 mcg administered 60 minutes before ECS could reduce the rate of neonatal RD and improve the neonatal respiratory outcomes.