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Safety of metoclopramide in the first trimester of pregnancy

Reference: N Engl J Med 2009; 360: 2528-2535

Source: NEJM

Date published: 11/06/2009 15:03

Summary
by: Yuet Wan

A paper in the New England Journal of Medicines examines the safety of metoclopramide use during the first trimester of pregnancy.

 

Data were obtained by linking information from a database of medication dispensed between January 1998, and March 2007 for women registered in the Clalit Health Services, southern district of Israel, with information from databases containing maternal and infant hospital records from the district hospital during the same period. The associations between the use of metoclopramide in pregnancy and adverse outcomes for the foetus were evaluated, adjusting for parity, maternal age, ethnic group, presence or absence of maternal diabetes, smoking status, and presence or absence of peripartum fever.

 

There were 113,612 singleton births during the study period and 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% CI, 0.89 to 1.21)

 

• Low birth weight (8.5% and 8.3%; 1.01, 0.89 to 1.14)

 

• Preterm delivery (6.3% and 5.9%; 1.15, 0.99 to 1.34)

 

• Perinatal death (1.5% and 2.2%; 0.87, 0.55 to 1.38)

 

The results were materially unchanged when therapeutic abortions of exposed and unexposed foetuses were included in the analysis. The researchers conclude that these findings provide reassurance of the safety of metoclopramide when given to women to relieve nausea and vomiting during the first trimester of pregnancy.