Esomeprazole - Medication and Pregnancy KB

Esomeprazole

Exposed non-exposed studies (cohort)

Study	Country Study period	Population source	Exposure definition	Non-exposure definition	Sample size	Rmk
Broe (Controls unexposed, general pop), 2025	Denmark 2004 - 2017	All singleton livebirths in Denmark between January 1, 2004, and December 31, 2017.	Singleton livebirths whose mothers had filled a prescription for Esomeprazole between the first day in the last menstrual period (LMP) and the end of the first trimester (91days after LMP).	unexposed (general population or NOS) Singleton livebirths of women who did not redeem any drug prescription between 90 days prior to LMP and the end of the first trimester.	1104 / 481595	Infants with chromosomal abnormalities (ICD-10 codes Q90– Q99) were excluded from all analyses.
Broe (Controls unexposed, sick), 2025	Denmark 2004 - 2017	All singleton livebirths in Denmark between January 1, 2004, and December 31, 2017.	Singleton livebirths whose mothers had filled a prescription for Esomeprazole between the first day in the last menstrual period (LMP) and the end of the first trimester (91days after LMP).	unexposed, sick Singleton livebirths born to women who were treated with the individual drug of interest during the last year before pregnancy, but not during pregnancy.	1104 / 2773	Infants with chromosomal abnormalities (ICD-10 codes Q90– Q99) were excluded from all analyses.
Choi a, 2023	South Korea 2011 - 2020	All pregnancies (in women aged 19-44 years) resulting in live births during the study period.	Pregnant women with one or more prescriptions for Esomeprazole during the first trimester (defined as the start of pregnancy to the 90th day of gestation).	unexposed, sick Pregnant women with no filled Proton Pump Inhibitor prescriptions from 90 days before pregnancy through the end of the first trimester (with a propensity-score, made by stratification notably concerning the indications => unexposed sick).	12516 / 2655676	In South Korea, 7 PPIs (omeprazole, esomeprazole, lansoprazole, dexlansoprazole, pantoprazole, rabeprazole, and ilaprazole) are available only with a prescription, and no over-the-counter PPIs are available.
Choi b, 2023	South Korea 2008 - 2019	All pregnancies in women < 44 years old resulting in live births during the study period.	Pregnant women that filled a prescription for Esomeprazole between the start of pregnancy and the 245th day of gestation.	unexposed, sick Pregnant women without exposure to proton pump inhibitors (PPIs) from 90 days before pregnancy to the delivery date.	12868 / 2121323	Unexposed group adjusted with propensity-score, made by stratification, notably concerning the indications => considered as unexposed sick (mathematical deformation of total population). In South Korea, PPIs only available with a prescription.
Pasternak, 2010	Denmark 1996 - 2008	A cohort of all live-born infants in Denmark for the study period.	Infants born to women who were exposed to esomeprazole (any filling of esomeprazole prescription at any time during the period from 4 weeks before conception through the end of the first trimester) (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed (general population or NOS) Infants born to women not exposed to PPIs (all the women who were not exposed at any time during their pregnancy).	668 / 832031

Case-control studies (cohort)

Study	Country Study period	Case	Control	Sample size	Rmk

Warning! There are no case-control studies available for this drug.

1 study, not fulfilled eligibility criteria, were excluded. See excluded tab for the list of these studies and reason of exclusion.

master protocol