Pantoprazole - Medication and Pregnancy KB

Pantoprazole

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 Pantoprazole 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)	6180 / 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.
Choi 2023			Prescription database.		during pregnancy (anytime or not specified)	6180 / 2121323
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 pantoprazole (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)	53 / 868
Diav-Citrin 2005			Details of exposure were collected during pregnancy before pregnancy outcome was known, using a structured questionnaire.		1st trimester, during pregnancy (anytime or not specified)	53 / 868
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 pantoprazole (any filling of pantoprazole 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	549 / 832031
Pasternak 2010	Denmark 1996 - 2008 population based cohort retrospective		The Prescription Drug Register provided information on all pantoprazole prescriptions filled by women in the cohort between 4 weeks before conception and delivery.		1st trimester, 2nd and/or 3rd trimester, preconception-only	549 / 832031

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

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

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

master protocol