Hyperemesis treatment not linked to risk of birth defects or stillbirth

The use of metoclopramide to treat nausea during pregnancy is not associated with an increased risk of stillbirth, major congenital malformations, or spontaneous abortion, according to a recent study in JAMA.

Danish researchers from the Statens Serum Institut analyzed 1,222,503 pregnancies occurring in Denmark from 1997 to 2011. Women exposed to metoclopramide (n = 28,486) and unexposed women (n = 113,698) were matched on the basis of age, calendar year, and propensity scores.

Of the women using metoclopromide in the first trimester, 721 had offspring with congenital malformations (25.3 cases per 1000 births, 95% confidence interval [CI], 23.5 – 27.1), while 3024 unexposed women delivered infants with congenital malformation (26.6 per 1000 births, 95% CI, 25.7 – 27.5). No significant associations were see between metoclopramide use and overall malformations (prevalence odds ration, 0.93 [95% CI, 0.86-1.02]), with the upper limit of 95% CI below 2.0 for 17 of the 20 categories.

No association was found between metoclopramide and spontaneous abortion, with 757 (20.0 [95% CI, 18.5-21.4] per 1000) cases in 37,946 women on metoclopramide and 9414 (62.1 [95% CI, 60.9 – 63.3] per 1000) cases among 151,661 unexposed women. Similarly, metoclopramide did not increase the risk of stillbirth. Among the 40,306 women using metoclopramide, there were 142 stillbirths (3.5 [95% CI, 2.9-4.1]) per 1000 births, while the 161,098 unexposed had 634 (3.9 [95% CI, 3.6-4.2 ]) per 1000 births.

The study’s authors concluded that metoclopramide was not associated with significant risks of spontaneous abortion, stillbirth, or malformation. They stated that the data from the study could help physicians make an informed decision about prescribing during pregnancy.

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