(P-238) Risk of Domperidone in Pregnant Women: A Study in the EFEMERIS Database

Background: Between 50 and 90% of women suffer from nausea and vomiting during pregnancy, especially during the first trimester. Domperidone is a dopaminergic antagonist neuroleptic antiemetic widely used during pregnancy in France, although its risks have not been adequately evaluated in pregnant women.

Objectives: To study the risk of pregnancy termination and congenital birth defect after exposure to domperidone during pregnancy.

Methods: The study was conducted in the EFEMERIS database and concerned 135,574 French women who had a pregnancy outcome between 1 July 2004 and 31 December 2017. The design was a cohort study comparing women exposed and unexposed to domperidone during pregnancy. Logistic regressions were applied to study the risk of congenital birth defect after exposure during the first trimester of pregnancy and Cox proportional risk models were used to study the risk of pregnancy termination.

Results: Overall, 13,964 pregnant women (10.3% of pregnancies) were prescribed and dispensed domperidone during pregnancy. Among them, 76.4% received domperidone during the 1st trimester of pregnancy, 20.3% during the 2nd trimester and 11.7% during the 3rd trimester. Exposure to domperidone has decreased continuously over time (from 17.1% of pregnant women in 2004 to 1.2% in 2017). The exposed pregnant women were significantly less educated (56.0% with higher education qualifications versus 62.7%) and were mostly not working during pregnancy (44.1% versus 41.2%). Pregnant women exposed to domperidone suffered more from disorders such as arterial hypertension during pregnancy (4.5% versus 3.8%) and diabetes before pregnancy (1.2% versus 0.9%). The rate of pregnancy termination in pregnant women exposed to domperidone was lower than that in unexposed pregnant women (3.4% versus 5.5%; aHR=0.78 [0.71-0.87]). The malformation rate in fetuses/newborns exposed in utero (1st trimester) to domperidone is not statistically different from the rate in unexposed group (2.2% versus 2.5%; aOR=0.89 [0.77-1.03]).

Conclusions: This first comparative study with a large number of pregnant women exposed to domperidone did not reveal harmful effects on newborns such as malformations. Women exposed to domperidone during pregnancy have a decreased risk for pregnancy termination, certainly due to an indication bias.