The Effect of Metoclopramide Administration to Mother on Newborn’s Bilirubin and Mother’s Prolactin: A Randomized Controlled Clinical Trial

Abstract

Abstract: Background: Jaundice is one of the most common neonatal problems which 60% of term neonates and 80% of preterm neonate suffer from it, causing the accumulation of bilirubin pigment and yellowish skin. Considering that in severe cases it can lead to kernikterus, hearing loss, encephalopathy and neurological disorder and if no actionis taken to treat and prevent it, it can cause a lot of health and medical costs. The aim of this study was to determine the effect of metoclopramide on neonatal bilirubin and maternal prolactin (primary outcomes) and the breast milk volume, maternal satisfaction, the frequency of exclusive breastfeeding, side effects and the use of effective drugs on breast milk (secondary outcomes). Methods: This triple-bind randomized controlled trial was conducted on 112 postpartum mothers within 10 hours after childbirth. The socio-demographic characteristics and characteristics of the newborns were completed by the participants before being allocated to the groups, then they were assigned into two intervention (Metoclopramide) and control groups (placebo) by blocked randomization. Metoclopramide and placebo tablets were taken at the dose of 10 mg, three times a day after breakfast, lunch and dinner by participants. The intervention began from 2 to 10 hours postpartum and continued until the fifth day. Also, the amount of prolactin was measured the morning after the onset of the intervention, taking into account the conditions of the test, and on the sixth day, one day after the completion of the intervention. The total bilirubin level of the baby was measured and recorded before intervention and on the 6th day. It should be noted that follow up on the 6th day of the study was conducted at the Taleghani Hospital Midwifery Emergency. The frequency of exclusive breastfeeding on the sixth day and the satisfaction of mothers from the lactation were measured by the relevant checklist, and on the sixth day, the breast milk volume was measured. ANCOVA test with adjustment of baseline values, independent T and chi-square tests were used for data analysis. Results: There was no statistically significant difference between two groups in terms of socio-demographic characteristics (p>0.05).After the intervention, there was no statistically significant difference between the two groups in terms of mean indirect bilirubin with adjusting the baseline control values (p=0.565). However, after the end of intervention, and with control of baseline values, mean serum prolactin in metoclopramide group was significantly higher than placebo group [adjusted mean difference: 37.3; CI 95%: 58.1 to 16.5].The frequency of jaundice in metoclopramide and placebo groups was 25% and 28.6%, which was not statistically significant (p= 0.711). 17.9% in the metoclopramide group and 14.3% in the placebo group were very satisfied with the lactation status, which was not statistically significant between the two groups (p= 0.436). Exclusive lactation in metoclopramide group and placebo group was 80.4% and 78.5%, respectively. There was no statistically significant difference between the two groups (p= 0.269). Side effect reported in both groups were anxiety, restlessness and headache. Conclusion: The metoclopramide had a positive effect on the increase in serum prolactin level, but had no effect on neonatal jaundice and breast milk volume, so because of the lack of study in this area is recommended more researches done in this field.