Lansoprazole

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 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 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). 		1st trimester 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.
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 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. 		during pregnancy (anytime or not specified) 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.
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 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. 		1st trimester, during pregnancy (anytime or not specified) 62 / 868
Details of exposure were collected during pregnancy before pregnancy outcome was known, using a structured questionnaire.
Källèn
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 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. 		1st trimester 13 / 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.
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 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. 		1st trimester 233 / 110550
Electronic database of medications dispensed by ‘‘Clalit’’ pharmacies.
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 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). 		1st trimester, 2nd and/or 3rd trimester, preconception-only 794 / 832031
The Prescription Drug Register provided information on all lansoprazole prescriptions filled by women in the cohort between 4 weeks before conception and delivery. (Omeprazole and Lansoprazole became OTC in 2006 and 2007 respectively).
Yitshak-Sade
2016 		Israel
1999 - 2008
retrospective cohort (registry) 		Clalit Health Services and The Soroka Medical Center Admission-Transfer-Discharge database. 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. 		during pregnancy (anytime or not specified) 346 / 86403
“Clalit” and Soroka Medical Center databases were encoded and linked to create a single registry of medications dispensed to children, and to their mothers before and during pregnancy.

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
Fejzo
2015 		USA
2007 - 2011
case control 		the Hyperemesis Education and Research Foundation Web site Children exposed to hyperemesis gravidarum (HG) with neurodevelopmental delay. Children exposed to hyperemesis gravidarum (HG) with a good outcome. Participants were asked to submit their medical records and complete an online survey regarding treatment. during pregnancy (anytime or not specified) 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).
Participants were asked to submit their medical records and complete an online survey regarding outcomes. A follow-up survey was administered on the diagnosis of childhood emotional, behavioral, and learning disorders.
Fejzo
2013 		USA
2007 - 2011
case control 		the Hyperemesis Education and Research Foundation Web site 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. Participants were asked to submit their medical records and complete an online survey regarding treatment. The majority of participants, both cases and controls, joined the study and began the survey during their pregnancies. during pregnancy (anytime or not specified) 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).
Participants were asked to submit their medical records and complete an online surveyregarding outcomes. The majority of participants, both cases and controls, were automatically prompted to complete the survey on outcome following their due date.
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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