Omeprazole

Exposed non-exposed, cohort studies

Study Country
Study period
Study design		 Data source Exposure definition Non-exposure definition Exposition period Sample size
(exposed/unexposed) Or (case / control)		 Remarks Risk of bias
Choi
2023 		South Korea
2008 - 2019
retrospective cohort (claims database) 		The National Health Insurance Service–National Health Information Database of South Korea, longitudinal health care records of more than 50 million inhabitants (approximately 99% of the South Korean population). 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. 		during pregnancy (anytime or not specified) 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.
Prescription database.
Diav-Citrin
2005 		Israel, Germany, Netherlands, Italy, France, Greece and Finland.
1992 - 2001
prospective cohort 		The European Network of Teratology Information Services (ENTIS) 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. 		1st trimester, during pregnancy (anytime or not specified) 295 / 868
Details of exposure were collected during pregnancy before pregnancy outcome was known, using a structured questionnaire.
Källén
2001 		Sweden
1995 - 1999
population based cohort retrospective 		The Swedish Medical Birth Registry, the Registry of Congenital Malformations and the Child Cardiology Register 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. 		2nd and/or 3rd trimester, at least 1st trimester 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.
The pregnant women are interviewed by a midwife during the first visit to the antenatal clinic. During the continued antenatal care, further drug use is recorded at the attendance of the woman to the antenatal care centers.
Källén
2003 		Sweden
1995 - 2001
population based cohort retrospective 		The Swedish Medical Birth Registry, the Swedish Registry of Congenital Malformations and the Swedish Child Cardiology Registry. 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. 		early pregnancy 1663 / 576067
At the first antenatal visit (usually week 10–12), a midwife interviewed the woman on the use of drugs during the pregnancy before the antenatal care visit. Throughout the subsequent antenatal care, additional prescriptions for drugs are recorded and also computerized.
Källèn (Controls exposed to other treatment, sick)
1998 		Sweden
1995 - 1997
population based cohort retrospective 		Swedish Medical Birth Registry, the Registry of Congenital Malformation and the Child Cardiology Register 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. 		1st trimester 262 / 255
At the first visit to the antenatal clinic (usually during weeks 10-12), the pregnant woman is interviewed by a midwife on drugs taken after the time the woman became pregnant and before the antenatal visit.
Lalkin (Controls exposed to other treatment, sick)
1998 		Canada, Italy and France
Not specified.
prospective cohort 		Motherisk, Telefono Rosso, Service De PharmacoToxicovigilance and Centro Regionale d’Informazione sul Farmaco. 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. 		1st trimester, during pregnancy (anytime or not specified) 113 / 113
Standardized data collection forms were used to obtain information by telephone or clinic interview. The controls were selected from the Motherisk database.
Lalkin (Controls unexposed NOS)
1998 		Canada, Italy and France.
Not specified.
prospective cohort 		Motherisk, Telefono Rosso, Service De PharmacoToxicovigilance and Centro Regionale d’Informazione sul Farmaco. 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. 		1st trimester, during pregnancy (anytime or not specified) 113 / 113
Standardized data collection forms were used to obtain information by telephone or clinic interview. Controls were selected from the Motherisk database.
Matok
2012 		Southern Israel
1998 - 2009
retrospective cohort (claims database) 		‘‘Clalit’’ pharmacies dispensation database, Soroka Medical Center database, The Obstetrics and Gynecology Department database and medical pregnancy termination SMC registry. 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. 		1st trimester 955 / 109828
Electronic database of medications dispensed by ‘‘Clalit’’ pharmacies.
Moretti
2001 		Canada
Not specified.
prospective cohort 		The Motherisk Program Exposed to omeprazole at least in firt trimester. unexposed (general population or NOS)
Unexposed to PPIs. 		at least 1st trimester 55 / 75 Unpublished study mentioned in the publication of 'Nikfar et al., 2002 Digestive Diseases and Sciences' as a personnal communication.
Not specified.
Pasternak
2010 		Denmark
1996 - 2008
population based cohort retrospective 		the Medical Birth Register, the Prescription Drug Register, the National Patient Register, The Central Person Register and Statistics Denmark 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). 		1st trimester, 2nd and/or 3rd trimester, preconception-only 1800 / 832031 The outcome for Polydactyly and Limb reduction weren't included because no data was available for a first trimester exposition.
The Prescription Drug Register provided information on all omeprazole prescriptions filled by women in the cohort between 4 weeks before conception and delivery. (Omeprazole and Lansoprazole became OTC in 2006 and 2007 respectively).
Ruigomez (Controls exposed to other treatment, sick)
1999 		United Kingdom and Italy
1991 - 1996
retrospective cohort 		United Kingdom General Practice Research Database and the Italian Friuli-Venezia Giulia Health Database 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. 		1st trimester 139 / 567
Italy: Computer files registered in the output registration database. UK: Prescriptions issued by the general practitioner are directly generated by the computer system.
Ruigomez (Controls unexposed NOS)
1999 		United Kingdom and Italy
1991 - 1996
retrospective cohort 		United Kingdom General Practice Research Database and the Italian Friuli-Venezia Giulia Health Database 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. 		1st trimester 139 / 1575
Italy: Computer files registered in the output registration database. UK: Prescriptions issued by the general practitioner are directly generated by the computer system.
Van Gelder
2022 		The Netherlands
2012 - 2019
prospective cohort 		The PRegnancy and Infant DEvelopment (PRIDE) Study and the Dutch Pregnancy Drug Register, two prospective ongoing cohorts, the Netherlands. 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. 		1st and 2nd trimester, 2nd and/or 3rd trimester, during pregnancy (anytime or not specified) 332 / 8502 Results of Proton Pump Inhibitors considered as a proxy of results for omeprazole because it represents 92.5% of PPI exposures.
Data on medication exposures were obtained from the three prenatal Web-based questionnaires (at baseline and in gestational weeks 17 and 34) and the first postpartum questionnaire. Proton Pump Inhibitor exposure was defined as report of medication belonging to ATC group A02BC.

Case-control studies

Study Country
Study period
Study design		 Data source Case Control Exposition Exposition period Sample size
(exposed/unexposed) Or (case / control)		 Remarks Risk of bias
Bànhidy
2011 		Hungary
1980 - 1996
case control 		The Hungarian Case-Control Surveillance of Congenital Abnormalities, The Hungarian Congenital Abnormality Registry and the National Birth Registry of the Central Statistical Office. Babies delivered with different CA (congenital abnormalities). Newborns delivered without CA (congenital abnormalities). Mothers were mailed a questionnaire (after the selection of cases and controls) requested information on medicinal products taken during pregnancy and to send their prenatal maternity logbook which related drug prescriptions. Regional nurses were asked to visit and question the non-respondent. during pregnancy (anytime or not specified) 22843 / 38151
Mothers were asked to send their prenatal maternity logbook and other medical records concerning their diseases during the pregnancy and their child’s CA. A questionnaire was also mailed requesting the same informations. Regional nurses were asked to question the non-respondent.
Kerr
2018 		USA and Canada
1993 - 2015
case control 		Slone Birth Defects Study (BDS) Infants with microcephaly alone (“isolated”) and microcephaly that included other major birth defects (“non-isolated”). Nonmalformed live-born infants. Within 6 months of delivery, nurse interviewers contacted mothers to complete a computer-assisted telephone interview to collect a detailed history of the pregnancy including illnesses and medications. 1st trimester, 2nd trimester, 3rd trimester 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.
Cases and controls were ascertained at participating hospitals or birth defect registries in the same areas.
Lind
2013 		USA
1997 - 2007
case control 		National Birth Defects Prevention Study (NBDPS) 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. The National Birth Defects Prevention Study uses computer-assisted telephone interviews to collect information from women 6 weeks to 24 months after their estimated date of delivery. 1st trimester 1537 / 4314 NBDPS excludes first-degree hypospadias. Arkansas, California, Georgia, Iowa, and Texas also include pregnancies that are diagnosed prenatally.
Cases are identified through population-based birth defects surveillance from each states. A clinical geneticist classifies eligible cases of hypospadias as isolated.

Risk of bias: : NA;   : low;   : moderate;   : serious;   : critical;   : unclear;  

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