Lansoprazole - Medication and Pregnancy KB

Lansoprazole

Exposed non-exposed studies (cohort)

Study	Country Study period	Population source	Exposure definition	Non-exposure definition	Sample size	Rmk
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 Lansoprazole 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).	6404 / 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 Lansoprazole 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.	8678 / 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 lansoprazole (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.	62 / 868
Källèn, 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 lansoprazole 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.	13 / 255
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 lansoprazole 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 lansoprazole in pregnancy.	233 / 110550
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 lansoprazole (any filling of lansoprazole 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).	794 / 832031
Yitshak-Sade, 2016	Israel 1999 - 2008	All children living in the Southern District of Israel (70% of the district population), born at Soroka Medical Center during the study period were included in this study.	Children whose mothers purchased Lansoprazole 2 months prior to conception and during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed (general population or NOS) Children not exposed during pregnancy.	346 / 86403

Case-control studies (cohort)

Study	Country Study period	Case	Control	Sample size	Rmk
Fejzo, 2015	USA 2007 - 2011	Children exposed to hyperemesis gravidarum (HG) with neurodevelopmental delay.	Children exposed to hyperemesis gravidarum (HG) with a good outcome.	138 / 174	Main analysis: case control related to the impact of the HG illness (treated or not) on child outcomes. Then impact of 37 medications/treatments (1st and/or 2nd trimester) on child outcome was investigated (none was significantly associated with delay).
Fejzo, 2013	USA 2007 - 2011	Pregnant women with hyperemesis gravidarum (HG) who have negative outcomes (birth weight less than 10%, perinatal mortality, and/or preterm birth (<37 weeks)).	Pregnant women with hyperemesis gravidarum (HG) who have positive outcomes.	43 / 211	Comparison of use of various medications/treatments in the two groups (43 HG participants with an adverse outcome compared to 211 HG participants with a good outcome).
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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