Shirin Osouli Tabrizi1, Mojgan Mirghafourvand2, Abdollah Jannat Dost3, Sakineh Mohammad-Alizadeh-Charandabi4, Yousef Javadzadeh5, Robabe Seyedi1. 1. Department of Midwifery, Students Research Committee, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran. 2. Midwifery Department, Social Determinants of Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. mirghafourvandm@tbzmed.ac.ir. 3. Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran. 4. Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran. 5. Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran.
Abstract
BACKGROUND: Jaundice is a common neonatal problem. This study was conducted to determine the effect of metoclopramide on neonatal bilirubin and maternal prolactin (primary outcomes) and milk volume (secondary outcome). METHODS: This triple-blind, randomized, controlled, clinical trial was conducted on 112 mothers. The participants were assigned to the intervention (metoclopramide) and control groups (placebo) using block randomization. Ten-mg metoclopramide and placebo tablets were taken by the participants three times a day. The intervention began in the first 2-10 hours after childbirth and continued until the fifth day. The mothers' prolactin level was measured on the first morning after the intervention and on the sixth day (1 day after the intervention was over). Neonatal total bilirubin was also measured before the intervention and on the sixth day. RESULTS: After the intervention, the two groups did not differ significantly in terms of the mean neonatal indirect bilirubin (P = 0.565) and milk volume (P = 0.261), but the mean serum prolactin was significantly higher in the metoclopramide group compared to the placebo group (adjusted mean difference 37; 95% confidence interval 58.1-16.5; P = 0.001). CONCLUSIONS:Metoclopramide increased maternal serum prolactin but had no effects on neonatal jaundice. The insufficient numbers of studies on this subject mandate further research.
RCT Entities:
BACKGROUND:Jaundice is a common neonatal problem. This study was conducted to determine the effect of metoclopramide on neonatal bilirubin and maternal prolactin (primary outcomes) and milk volume (secondary outcome). METHODS: This triple-blind, randomized, controlled, clinical trial was conducted on 112 mothers. The participants were assigned to the intervention (metoclopramide) and control groups (placebo) using block randomization. Ten-mg metoclopramide and placebo tablets were taken by the participants three times a day. The intervention began in the first 2-10 hours after childbirth and continued until the fifth day. The mothers' prolactin level was measured on the first morning after the intervention and on the sixth day (1 day after the intervention was over). Neonatal total bilirubin was also measured before the intervention and on the sixth day. RESULTS: After the intervention, the two groups did not differ significantly in terms of the mean neonatal indirect bilirubin (P = 0.565) and milk volume (P = 0.261), but the mean serum prolactin was significantly higher in the metoclopramide group compared to the placebo group (adjusted mean difference 37; 95% confidence interval 58.1-16.5; P = 0.001). CONCLUSIONS:Metoclopramide increased maternal serum prolactin but had no effects on neonatal jaundice. The insufficient numbers of studies on this subject mandate further research.
Authors: Michael Kaplan; Maurizio Muraca; Cathy Hammerman; Firmino F Rubaltelli; Maria T Vilei; Hendrik J Vreman; David K Stevenson Journal: Pediatrics Date: 2002-10 Impact factor: 7.124