Effect of metoclopramide administration to mothers on neonatal bilirubin and maternal prolactin: a randomized, controlled, clinical trial
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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).
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.
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).
Metoclopramide increased maternal serum prolactin but had no effects on neonatal jaundice. The insufficient numbers of studies on this subject mandate further research.
KeywordsBilirubin Metoclopramide Milk volume Neonate Prolactin
We wish to express our gratitude to Mr. Neginfar (Alzahra Laboratory Technician) and all the participants.
SOT and RS contributed to the study design, data collection, data interpretation and writing of the manuscript. MM, AJD, and SM contributed to study design, data interpretation and revision of the manuscript. YJ contributed to study design, data interpretation and revision of the manuscript, and prepared drug and placebo. All authors approved the final version of the manuscript.
This study was funded by Tabriz University of Medical Sciences.
Compliance with ethical statements
This study was approved by the Ethics Committee of the Research and Technology Deputy of Tabriz University of Medical Sciences (IR.TBZMED.REC.1395.1020). Written informed consent was obtained from all individual participants included in the study.
Conflict of interest
No financial or nonfinancial benefits have been received or will be received from any party related directly or indirectly to the subject of this article.
- 13.Metoclopramide. https://www.drugbank.ca/drugs/DB01233. Accessed 14 Jun 2017.
- 16.Food & Drug Administration. FDA requires boxed warning and risk mitigation strategy for metoclopramide-containing drugsagency warns against chronic use of these products to treat gastrointestinal disorders. 2009. http://www.fda.gov/bbs/topics/NEWS/2009/NEW01963.html. Accessed 28 Feb 2017.
- 19.Donovan TJ, Buchanan K. Medications for increasing milk supply in mothers expressing breastmilk for their preterm hospitalised infants. Cochrane Database Syst Rev. 2012;3:CD005544.Google Scholar
- 20.Dastgerdi E, Shirazi M, Mohammadzadeh A, Shahrarha A, Amiri R. Effect of metoclopramide on increased milk production in mothers of preterm infants. J Gyn Ir. 2011;14:32–6 (in Persian).Google Scholar
- 24.Lawrence R, Lawrence R. Breastfeeding: a guide for the medical professional. 7th ed. Philadelphia: Saunders; 2011.Google Scholar
- 25.Gullu S. Prolactin: an underestimated hormone. Endocrine abstracts. 2008;16:ME9. https://www.endocrine-abstracts.org/ea/0016/ea0016me9. Accessed 12 Nov 2017.
- 26.Saeidi R, Gholami Robatsangi M, Mirza Rahimi M, Amiri Tehrani Zadeh M. Comparison of serum bilirubin measurement in laboratory and transcutaneous bilirubinometry. J Sabzevar Univ Med Sci. 1970;16:150–4 (in Persian).Google Scholar
- 30.Ștefănescu E, Pleșu M, Scutari C, Junghină A, Mireșan H. Metoclopramide neurological side effects screening; a pharmacovigilence study in Romanian community pharmacies. J Mind Med Sci. 2015;2:55–66.Google Scholar