A Randomised Controlled Trial on the Effectiveness of Melatonin in Controlling Blood Loss during Ceaserean Section in a Tertiary Centre in Southeast Nigeria

Abstract

Background: Caesarean section is a common surgical procedure in Obstetrics.  Despite the safety in carrying out caesarean section, it is still associated with blood loss and need for blood transfusion when compared to women who had vaginal delivery. Despite the use of uterotonic such as oxytocin, to prevent postpartum haemorrhage, excessive bleeding still occurs during and after caesarean section. Melatonin has been shown to reduce blood loss, which may be useful in prevention of postpartum haemorrhage. Hence, we aimed to determine the efficacy of Melatonin in reducing blood loss during and after elective caesarean section. Methodology: This was a double-blind randomised controlled trial. Data analysis was done using IBM SPSS (version 25, Chicago II, USA). Continuous variables were presented as mean and standard deviation (Mean ± 2SD), while categorical variables were presented as numbers and percentages. The categorical variables were analysed using Chi square, while means were compared using t-test and Mann-Whitney U test for non-parametric. A P value <0.05 was considered statistically significant. Result: Sublingual melatonin reduced blood loss by an average of 76.67ml (0.44%) at elective caesarean section compared with placebo group (955.00ml versus 1031.67ml respectively), however this was not statistically significant  (p-value = 0.097). Participants that received blood transfusion were higher in placebo group than melatonin group {29 (17.9%) versus 19 (11.7%)} however, the difference was not statistically significant (p-value = 0.159. Moreover, participants that required additional oxytocic were also higher in placebo group compared to melatonin group {45(27.8%) versus 34 (21.0%)} however, the difference between the two was not statistically significant, (p-value is 0.196). There was no major maternal or neonatal side effect. Conclusion: This study demonstrated that 8mg sublingual melatonin did not significantly reduce blood loss at elective caesarean section. However, more participants in the placebo group required more oxytocic and blood transfusion. So higher doses and/or repetitive doses should be explored in future researches.