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 a 2023 |
South Korea 2011 - 2020 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 with one or more prescriptions for Rabeprazole 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). |
1st trimester | 13414 / 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. | |
Prescription database. | ||||||||
Choi b 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 Rabeprazole 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) | 11934 / 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. | ||||||||
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 rabeprazole (any filling of rabeprazole 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 | 42 / 832031 | ||
The Prescription Drug Register provided information on all rabeprazole prescriptions filled by women in the cohort between 4 weeks before conception and delivery. |
Study | Country Study period Study design |
Data source | Case | Control | Exposition | Exposition period | Sample size (exposed/unexposed) Or (case / control) |
Remarks | Risk of bias |
---|
Risk of bias: : NA; : low; : moderate; : serious; : critical; : unclear;