Omeprazole - Medication and Pregnancy KB

Omeprazole

Exposed non-exposed studies (cohort)

Study	Country Study period	Population source	Exposure definition	Non-exposure definition	Sample size	Rmk
Choi, 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 Omeprazole 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.	3372 / 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.
Diav-Citrin, 2005	Israel, Germany, Netherlands, Italy, France, Greece and Finland. 1992 - 2001	Pregnant women who or whose physician/midwife contacted one of eight Teratology Information Services (TISes).	Pregnancies with exposure to omeprazole (This is a subgroup of exposure among the whole exposed group considered in the study ).	unexposed (general population or NOS) Group of women who had been counselled during pregnancy in regard to exposures known to be nonteratogenic from seven of the eight participating centres.	295 / 868
Källén, 2001	Sweden 1995 - 1999	All birth registered in the Swedish Medical Birth Registry during the study period.	Infants of women who had reported the use of omeprazole during pregnancy.	unexposed (general population or NOS) Infants of women who didn't used omeprazole during pregnancy.	955 / -9	The hospital discharge register which contains information on every hospitalized patient in Sweden is not yet ready for 1998 - 1999, hence the study had to be limited to hospitalizations up to the end of 1997.
Källén, 2003	Sweden 1995 - 2001	All infants born in Sweden during the study period. Stillbirths were included both among cases and in the population controls.	Infants exposed to omeprazole during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed (general population or NOS) Infants non-exposed to omeprazole during pregnancy.	1663 / 576067
Källèn (Controls exposed to other treatment, sick), 1998	Sweden 1995 - 1997	The approximate number of births from which the cohort was identified is 200000.	Infants were identified from the register whose mothers had used omeprazole after becoming pregnant and before the first antenatal visit (approximately first trimester exposure). (This is a subgroup of exposure among the whole exposed group considered in the study).	exposed to other treatment, sick Infants exposed to H2 receptor antagonists during pregnancy.	262 / 255
Lalkin (Controls exposed to other treatment, sick), 1998	Canada, Italy and France Not specified.	All women exposed to omeprazole during pregnancy and counseled by the participating centers were included.	Women exposed to omeprazole during pregnancy.	exposed to other treatment, sick Women with similar conditions for which omeprazole was taken but who took histamine blockers.	113 / 113
Lalkin (Controls unexposed NOS), 1998	Canada, Italy and France. Not specified.	All women exposed to omeprazole during pregnancy and counseled by the participating centers were included.	Women exposed to omeprazole during pregnancy.	unexposed (general population or NOS) A nonteratogenic control, which included women who contacted Motherisk in a similar manner but who were exposed to a nonteratogenic agent.	113 / 113
Matok, 2012	Southern Israel 1998 - 2009	All girls and women 15–49 years of age registered in ‘‘Clalit’’ and living in the southern district who gave birth to singletons at ‘Soroka’’ Medical Center and all medical pregnancy terminations performed between the study period.	Infants of women to whom omeprazole were dispensed during pregnancy (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed (general population or NOS) Fetuses of all women who did not take omeprazole in pregnancy.	955 / 109828
Moretti, 2001	Canada Not specified.	Not specified.	Exposed to omeprazole at least in firt trimester.	unexposed (general population or NOS) Unexposed to PPIs.	55 / 75	Unpublished study mentioned in the publication of 'Nikfar et al., 2002 Digestive Diseases and Sciences' as a personnal communication.
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 omeprazole (any filling of omeprazole 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).	1800 / 832031	The outcome for Polydactyly and Limb reduction weren't included because no data was available for a first trimester exposition.
Ruigomez (Controls exposed to other treatment, sick), 1999	United Kingdom and Italy 1991 - 1996	Italy : all women younger than 45 years with a hospital delivery between the study period. UK : women younger than 45 years with a code of pregnancy between the study period.	Offspring whose mothers had prescription of omeprazole any time from 180 days before the first recorded date of a pregnancy code until 180 days afterward (This is a subgroup of exposure among the whole exposed group considered in the study). Addition of UK and Italy cohort.	exposed to other treatment, sick Offspring whose mothers had prescription of ranitidine or cimetidine (H2 blockers) any time from 180 days before the first recorded date of a pregnancy code until 180 days afterward.	139 / 567
Ruigomez (Controls unexposed NOS), 1999	United Kingdom and Italy 1991 - 1996	Italy : all women younger than 45 years with a hospital delivery between the study period. UK : women younger than 45 years with a code of pregnancy between the study period.	Offspring whose mothers had prescription of omeprazole any time from 180 days before the first recorded date of a pregnancy code until 180 days afterward (This is a subgroup of exposure among the whole exposed group considered in the study). Addition of UK and Italy cohort.	unexposed (general population or NOS) Offspring whose mothers were nonexposed during pregnancy.	139 / 1575
Van Gelder, 2022	The Netherlands 2012 - 2019	Women aged >= 18 years invited to participate to study cohort as early in pregnancy as possible.	Report of Omeprazole exposure during pregnancy. Proton Pump Inhibitors considered as a proxy of results for omeprazole because it represents 92.5% of PPI exposures.	unexposed (general population or NOS) No report of Proton Pump Inhibitor (ATC group A02BC) exposure during pregnancy.	332 / 8502	Results of Proton Pump Inhibitors considered as a proxy of results for omeprazole because it represents 92.5% of PPI exposures.

Case-control studies (cohort)

Study	Country Study period	Case	Control	Sample size	Rmk
Bànhidy, 2011	Hungary 1980 - 1996	Babies delivered with different CA (congenital abnormalities).	Newborns delivered without CA (congenital abnormalities).	22843 / 38151
Kerr, 2018	USA and Canada 1993 - 2015	Infants with microcephaly alone (“isolated”) and microcephaly that included other major birth defects (“non-isolated”).	Nonmalformed live-born infants.	166 / 12059	Authors analyzed separately “isolated” microcephaly and “non-isolated” microcephaly. Only isolated microcephaly are indexed in MetaPreg. Cases with chromosomal or syndrome diagnosis and potential congenital infections were excluded.
Lind, 2013	USA 1997 - 2007	Male infants with isolated second- or third-degree hypospadias, defined as the urethral opening at the penile shaft, scrotum, or perineum.	Male infants with no major birth defects selected randomly from vital records or birth logs.	1537 / 4314	NBDPS excludes first-degree hypospadias. Arkansas, California, Georgia, Iowa, and Texas also include pregnancies that are diagnosed prenatally.

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