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Previous Volume 360:2528-2535 June 11, 2009 Number 24 Next

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ABSTRACT

Background In various countries, metoclopramide is the antiemetic drug of choice in pregnant women, but insufficient information exists regarding its safety in pregnancy.

Methods We investigated the safety of metoclopramide use during the first trimester of pregnancy by linking a computerized database of medications dispensed between January 1, 1998, and March 31, 2007, to all women registered in the Clalit Health Services, southern district of Israel, with computerized databases containing maternal and infant hospital records from the district hospital during the same period. We assessed associations between the use of metoclopramide in pregnancy and adverse outcomes for the fetus, adjusting for parity, maternal age, ethnic group, presence or absence of maternal diabetes, smoking status, and presence or absence of peripartum fever.

Results There were 113,612 singleton births during the study period. A total of 81,703 of the infants (71.9%) were born to women registered in Clalit Health Services; 3458 of them (4.2%) were exposed to metoclopramide during the first trimester of pregnancy. Exposure to metoclopramide, as compared with no exposure to the drug, was not associated with significantly increased risks of major congenital malformations (5.3% and 4.9%, respectively; odds ratio, 1.04; 95% confidence interval [CI], 0.89 to 1.21), low birth weight (8.5% and 8.3%; odds ratio, 1.01; 95% CI, 0.89 to 1.14), preterm delivery (6.3% and 5.9%; odds ratio, 1.15; 95% CI, 0.99 to 1.34), or perinatal death (1.5% and 2.2%; odds ratio, 0.87; 95% CI, 0.55 to 1.38). The results were materially unchanged when therapeutic abortions of exposed and unexposed fetuses were included in the analysis.

Conclusions In this large cohort of infants, exposure to metoclopramide in the first trimester was not associated with significantly increased risks of any of several adverse outcomes. These findings provide reassurance regarding the safety of metoclopramide for the fetus when the drug is given to women to relieve nausea and vomiting during pregnancy.

Source Information

From the Departments of Epidemiology and Health Services Evaluation (I.M., A.L.), Pediatrics (R.G.), and Obstetrics and Gynecology (E.S., A.W.), Faculty of Health Sciences, Ben-Gurion University of the Negev; Soroka Medical Center (R.G., E.S., A.W.), Clalit Health Services (Southern District) (R.G., A.W.), and the BeMORE Collaboration (R.G., A.L.) — all in Beer-Sheva, Israel; the Motherisk Program, Division of Clinical Pharmacology, Hospital for Sick Children, University of Toronto, and the BeMORE Collaboration, Toronto (G.K.); and the Department of Medicine, University of Western Ontario, London, Canada (G.K.).

Address reprint requests to Dr. Gorodischer at the Soroka Medical Center, P.O. Box 151, Beer-Sheva 84101, Israel, or at rafaelg{at}bgu.ac.il.

Full Text of this Article

This article has been cited by other articles:

• (2009). All you need to read in the other general journals. BMJ 338: b2417-b2417 [Full Text]  
• (2009). Metoclopramide During Early Pregnancy: How Safe?. JWatch Women's Health 2009: 1-1 [Full Text]