| 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 |
|---|---|---|---|---|---|---|---|---|
|
Chun-Fai-Chan (Controls exposed to other antidepressants) 2005 |
Canada, UK and USA Not specified prospective cohort |
The Motherisk Program (Toronto, Canada), the Pregnancy Riskline (Farmington, Conn, USA) and The Drug Safety Research Unit (Southampton, UK). | Women who called either service, and that were taking bupropion for depression in the first trimester. |
exposed to other treatment, sick
Women who had contacted the Motherisk program, and that were exposed to other antidepressant during pregnancy. |
at least 1st trimester | 91 / 89 | Probable overlapping (despite the lack of study period) between Einarson 2009 and Chun-Fai-Chan 2005 which included more pregnancies exposed to bupropion (n=136) and that studied more outcomes. Therefore Chun-Fai-Chan 2005 used rather than Einarson 2009. | |
| The physicians or women are contacted and asked to prospectively complete exposure history, that included: medical indication, dose used, frequency of administration, gestational age at exposure. | ||||||||
|
Chun-Fai-Chan (Controls unexposed, NOS) 2005 |
Canada, UK and USA Not specified prospective cohort |
The Motherisk Program (Toronto, Canada), the Pregnancy Riskline (Farmington, Conn, USA) and The Drug Safety Research Unit (Southampton, UK). | Women who called either service, and that were taking bupropion in the first trimester. |
unexposed (general population or NOS)
Women who had contacted the Motherisk program, but were not exposed to any teratogens during pregnancy. |
at least 1st trimester | 136 / 133 | Probable overlapping (despite the lack of study period) between Einarson 2009 and Chun-Fai-Chan 2005 which included more pregnancies exposed to bupropion (n=136) and that studied more outcomes. Therefore Chun-Fai-Chan 2005 used rather than Einarson 2009. | |
| The physicians or women are contacted and asked to prospectively complete exposure history, that included: medical indication, dose used, frequency of administration, gestational age at exposure. | ||||||||
|
Cole 2007 |
USA 1995 - 2004 retrospective cohort (claims database) |
The Ingenix Research Data Mart (RDM) from UnitedHealthcare affiliated health plans, USA. | Infants born to women with a dispensing of bupropion during the estimated first trimester, or with a bupropion dispensing preceding the estimated first trimester with the days supplied extending into the first trimester. |
exposed to other treatment, sick
Infants born to women with a dispensing of antidepressants other than bupropion during the estimated first trimester, or before the first trimester with the days supplied extending into the first trimester. |
1st trimester | 1213 / 4743 | The other control group (women dispensed bupropion within 18 months before delivery, or after the estimated first trimester of pregnancy and before delivery) nor reported here. | |
| Use of the claims for prescription dispensings along with membership data. | ||||||||
|
Einarson 2009 |
Canada Not specified. prospective cohort |
The Motherisk Program, a teratogenic information service. | Pregnant women who were exposed to Bupropion in the first trimester of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
Pregnant women who were not exposed to antidepressants and who had called Motherisk for information regarding nonteratogenic drugs. |
1st trimester | 113 / 928 | ||
| During the initial telephone contact, details of exposure and concurrent exposures are recorded on a standardized questionnaire. | ||||||||
|
Figueroa 2010 |
USA 1997 - 2006 retrospective cohort (claims database) |
The MarketScan data used in this study, collected by Thompson Reuters (previously Medstat), obtained from large self-insured employers from all states, except Alaska and Hawaii. | Children born to mothers with a prescription filled of Bupropion during pregnancy. |
unexposed, sick
Children born to depressed mothers who were not exposed to antidepressants during pregnancy |
1st trimester, 2nd trimester, 3rd trimester, during pregnancy (anytime or not specified) | 114 / 3532 | For ADHD: partial overlapping between Suarez 2022 (Two databases, including MarketScan from 2003 to 2015) and Figueroa 2010 (Marketscan: 1997 - 2006) => Uncommon period study longer than common study period => the 2 studies were kept. | |
| The MarketScan data contain information including prescription claims and the date of the service. | ||||||||
|
Huybrechts (Controls unexposed, NOS) 2014 |
USA 2000 - 2007 retrospective cohort (claims database) |
Cohort study nested in the nationwide Medicaid Analytic eXtract. | Pregnant women who have had exposure to Bupropion with the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
Pregnant women without exposure to antidepressants during the first trimester. |
1st trimester | 8856 / 885115 | Exclusion of pregnancies with a diagnosis of a chromosomal abnormality and pregnancies in which the mother had been treated with known teratogens during the first trimester (i.e., lithium, antineoplastic agents, retinoids, and thalidomide). | |
| The Medicaid Analytic eXtract data set that contains data on all filled outpatient medication prescriptions. | ||||||||
|
Huybrechts (Controls unexposed, sick) 2014 |
USA 2000 - 2007 cohort |
Cohort study nested in the nationwide Medicaid Analytic eXtract. | Pregnant women who have had exposure to Bupropion with the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Pregnant women with a diagnosis of depression without exposure to antidepressants during the first trimester. |
1st trimester | 8856 / 180564 | Use of High-dimensional propensity-score data (Supplementary Table S15). Exclusion of pregnancies in which the mother had been treated with known teratogens during the first trimester (i.e., lithium, antineoplastic agents, retinoids, and thalidomide). | |
| The Medicaid Analytic eXtract data set that contains data on all filled outpatient medication prescriptions. | ||||||||
|
Jackson 2024 |
U.S.A 2019 - 2022 retrospective cohort (claims database) |
Inpatient electronic medical record system (Sunrise Clinical Manager, Allscripts Corp., Chicago, IL) of 7 hospitals within a large academic health system in New York. | Prenatal exposure to a monotherapy of dopamine-norepinephrine reuptake inhibitors (DNRIs: buproprion) |
unexposed, disease free
No prenatal exposure to dopamine-norepinephrine reuptake inhibitors (DNRIs: buproprion). |
during pregnancy (anytime or not specified) | 55 / 107051 | ||
| Medication exposure was determined by its presence or absence in the medication reconciliation document completed during hospital admission. | ||||||||
|
Kjaersgaard 2013 |
Denmark 1997 - 2008 population based cohort retrospective |
Danish administrative health registries. | Mother that had redeemed a prescription for Bupropion at any time from 30 days before conception up to 1 day before the end of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
Mother that had not redeemed any prescription for antidepressant medication from 6 months before conception up to 1 day before the end of the pregnancy. |
during pregnancy (anytime or not specified) | -9 / 983258 | Molar or ectopic pregnancies (ICD-10: O00.0– O01.9) were excluded from the main analyses. Unexposed cohort: 1843 plus 981415 = 983258. | |
| Information on all redeemed prescriptions was obtained from the Denmark Registry of Medicinal Product Statistics. | ||||||||
|
Marks (Controls exposed to Sertraline) 2021 |
USA 2010 - 2019 retrospective cohort |
Electronic medical records (EMRs) through the Regenstrief Institute in Indianapolis, USA. | Pregnant women with one (or more) prescription of Bupropion written during the time period studied. (This is a subgroup of exposure among the whole exposed group considered in the study) |
exposed to other treatment, sick
Pregnant women with one (or more) prescription of Sertraline written during the time period studied. (This is a subgroup of exposure among the whole exposed group considered in the study) |
during pregnancy (anytime or not specified) | 406 / 1653 | '252 women (6.8%) prescribed >1 antidepressant'=> considered as monotherapy. In the study, use of bupropion as reference group. Here, we took the inverse of ORa. | |
| Data were obtained from electronic medical records (EMRs) through the Regenstrief Institute in Indianapolis. | ||||||||
|
Marks (Controls unexposed, sick) 2021 |
USA 2010 - 2019 retrospective cohort |
Electronic medical records (EMRs) through the Regenstrief Institute in Indianapolis, USA. | Pregnant women with one (or more) prescription of Bupropion during the third trimester exposure. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Pregnant women who took an antidepressant at some point during pregnancy but did not have a prescription for any antidepressant during the relevant period of exposure. |
3rd trimester | 172 / -9 | '252 women (6.8%) prescribed >1 antidepressant'=> considered as monotherapy. 'Neonatal intensive care unit admission" => not considered here because an exposure in early pregnancy could also lead to NICU admission. | |
| Data were obtained from electronic medical records (EMRs) through the Regenstrief Institute in Indianapolis. | ||||||||
|
Ozturk 2016 |
Turkey 2007 - 2012 prospective cohort |
An observational cohort study based on a prenatal consultation service. | Pregnant women exposed to Bupropion during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
Pregnant women selected from the non-teratogen exposed pregnancies in the same year. |
at least 1st trimester | 1 / 275 | 'Drug exposures took place in 81% during the first trimester, and 11% in all three trimesters. Medical treatments were discontinued in most of recognized pregnancies.'=> considered as 'At least first trimester'. | |
| At the first contact, initiated via gynecologists, a detailed patient history form was used to notably record all drug exposures (dose, duration and timing in pregnancy). | ||||||||
|
Palmsten (control exposed to SSRIs) 2013 |
USA 2000 - 2007 retrospective cohort (claims database) |
The US nationwide Medicaid Analytic eXtract (MAX). | Pregnant women with a depression diagnosis and a dispensation of Bupropion in monotherapy during the exposure window. |
exposed to other treatment, sick
Pregnant women with a depression diagnosis and a dispensation of selective serotonin reuptake inhibitor (SSRI) in monotherapy during the exposure window. |
2nd and/or 3rd trimester | 2622 / 19000 | Women who received only one antidepressant class during the window were classified as having either SSRI, SNRI, tricyclic, bupropion or other antidepressant (mirtazapine, nefazodone, trazodone) monotherapy. | |
| Outpatient pharmacy-dispensing data. | ||||||||
|
Palmsten (Controls unexposed, sick) 2013 |
USA 2000 - 2007 retrospective cohort (claims database) |
The US nationwide Medicaid Analytic eXtract (MAX). | Pregnant women with a depression diagnosis and a dispensation of Bupropion in monotherapy during the exposure window. |
unexposed, sick
Pregnant women with a depression diagnosis and no antidepressant exposure between the LMP and the end of the window. |
2nd and/or 3rd trimester | 2622 / 59219 | Women who received only one antidepressant class during the window were classified as having either SSRI, SNRI, tricyclic, bupropion or other antidepressant (mirtazapine, nefazodone, trazodone) monotherapy. | |
| Outpatient pharmacy-dispensing data. | ||||||||
|
Palmsten b 2013 |
USA 2000 - 2007 retrospective cohort (claims database) |
The Medicaid Analytic eXtract (MAX) data | Women with a supply of Bupropion monotherapy that overlapped with the delivery date. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Women who had no supply of antidepressants in the five months before delivery. |
late pregnancy | 1162 / 69044 | Exclusion of women who were exposed to both drugs types (polytherapy) during the five months before delivery. | |
| Data of prescription. | ||||||||
|
Suarez (Controls unexposed, discontinuers) 2022 |
USA 2000 - 2015 retrospective cohort (claims database) |
The Medicaid Analytic eXtract (MAX) and the MarketScan Commercial Claims Database (MarketScan), USA. | Individuals with at least 1 dispensing of bupropion from 127 days after LMP (week 19 of gestation) to delivery. |
unexposed, sick
Individuals that having a dispensing for bupropion in the window from 90 to 31 days prior to LMP but not during the window of 30 days prior to LMP through delivery. |
2nd and/or 3rd trimester | 19341 / 6896 | For ADHD: partial overlapping between Suarez 2022 (Two databases, including MarketScan from 2003 to 2015) and Figueroa 2010 (Marketscan: 1997 - 2006) => Uncommon period study longer than common study period => the 2 studies were kept. | |
| The Medicaid Analytic eXtract (MAX) and the MarketScan Commercial Claims Database (MarketScan), that include information on dispensed outpatient prescription medications. | ||||||||
|
Suarez (Controls unexposed, general pop) 2022 |
USA 2000 - 2015 retrospective cohort (claims database) |
The Medicaid Analytic eXtract (MAX) and the MarketScan Commercial Claims Database (MarketScan), USA. | Individuals with at least 1 dispensing of bupropion from 127 days after LMP (week 19 of gestation) to delivery. |
unexposed (general population or NOS)
Individuals with no antidepressants dispensing from 90 days prior to pregnancy start through the day prior to delivery. |
2nd and/or 3rd trimester | 19426 / 2981692 | For ADHD: partial overlapping between Suarez 2022 (Two databases, including MarketScan from 2003 to 2015) and Figueroa 2010 (Marketscan: 1997 - 2006) => Uncommon period study longer than common study period => the 2 studies were kept. | |
| The Medicaid Analytic eXtract (MAX) and the MarketScan Commercial Claims Database (MarketScan), that include information on dispensed outpatient prescription medications. | ||||||||
|
Thyagarajan 2012 |
USA 1995 - 2004 retrospective cohort (claims database) |
The Ingenix Research Data Mart (RDM) from UnitedHealthcare affiliated health plans, USA. | Infants born to women with a dispensing of bupropion during the estimated first trimester, or with a bupropion dispensing preceding the estimated first trimester with the days supplied extending into the first trimester. |
exposed to other treatment, sick
Infants born to women with a dispensing of antidepressants other than bupropion during the estimated first trimester, or before the first trimester with the days supplied extending into the first trimester. |
1st trimester | -9 / -9 | Authors utilized the same study population identified from an administrative claims database for the Cole et al. (2007) study of bupropion use during pregnancy => Methods based on Cole' publication. | |
| Use of the claims for prescription dispensings along with membership data. | ||||||||
|
Yaris 2005 |
Turkey 1999 - 2004 prospective cohort |
Toxicology Information and Follow-up Service | Women who were exposed to Bupropion during pregnancy for depression, anxiety, and psychotic disorders. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
Women who did not use any drug while pregnant. |
during pregnancy (anytime or not specified) | 1 / 248 | Raw data for Intrauterine exitus not reported because the nb of cases in the unexposed group not clearly stated. Raw data for premature delivery not reported because the denominator is not clearly stated. | |
| Data surveyed by the interviews. | ||||||||
|
Yeh 2021 |
Taiwan 2002 - 2011 retrospective cohort (claims database) |
The Taiwan National Health Insurance Research Database (NHIRD). | Pregnant women with bipolar disorder receiving dopamine norepinephrine reuptake inhibitor (i.e Bupropion) during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Pregnant women with bipolar disorder not receiving any psychotropics before and during the pregnancy. |
1st trimester, during pregnancy (anytime or not specified) | 7 / 5243 | ||
| The Taiwan National Health Insurance Research Database (THIRD) provides prescriptions information about insured individuals. | ||||||||
| Study | Country Study period Study design |
Data source | Case | Control | Exposition | Exposition period | Sample size (exposed/unexposed) Or (case / control) |
Remarks | Risk of bias |
|---|---|---|---|---|---|---|---|---|---|
|
Anderson 2020 |
USA 1997 - 2011 case control |
The National Birth Defects Prevention Study (NBDPS), a US population-based, multisite case-control study. | The case infants were infants born alive or died at 20 SG or more and who had received a diagnosis of at least one selected birth defect. | The controls were live-born infants with no major birth defects who were randomly selected from hospital or state birth-certificate records from the same geographic areas. | Information on exposure to antidepressants and other potential risk factors during pregnancy were collected by standardized telephone interviews with mothers of case and control infants, conducted 6 weeks to 24 months after the EDD. | 1st trimester | 30630 / 11478 | 'Infants with recognized or strongly suspected chromosomal abnormalities or single-gene conditions were excluded from the study.'Overlapping: data of Lind 2013 and Alwan 2010 totally included in this larger study, thus we reported only Anderson 2020. | |
| Case infants were ascertained through population-based birth-defects surveillance systems in 10 U.S. states. Controls were selected randomly from the same geographic areas. Clinical data were abstracted from medical records and classified by clinician geneticists and other clinicians. | |||||||||
|
Laspro 2024 |
USA 2013 - 2023 nested case control |
EPIC Cosmos, a database incorporating health information of 180 million patients, throughout the United States from approximately 180 US institutions utilizing EPIC medical records. | Newborns with oral clefts (ICD 10 codes Q35 or Q36 or Q37). | Newborns without oral clefts. | Gestational medication use was identified by medications, prescribed, provider-administered, or reported use by mothers at any point during pregnancy. | during pregnancy (anytime or not specified) | 12098 / -9 | P-values were calculated, while to account for multiple testing (693 hypotheses) Benjamini- Hochberg (BH) corrections were performed with a false discovery rate (Q) of 0.05. | |
| Oral cleft cohorts were isolated using a combination of ICD codes, from the EPIC medical records. | |||||||||
|
Louik 2014 |
USA and Canada 1992 - 2011 case control |
The Slone Epidemiology Center’s Birth Defects Study (BDS), a multi-center case-control surveillance program for birth defects. | Infants with any of a wide range of malformations (infants with isolated minor defects are excluded).. | Infants without malformations. | Mothers are invited to participate in a telephone interview after delivery, conducted by trained nurses who are unaware of the study hypotheses. It collects detailed data on all medications (prescription, over-the-counter, ...) used anytime from 2 months prior to conception through the pregnancy. | 1st trimester | 2734 / 8611 | Data available for Bupropion alone and for Bupropion in polytherapy of antidepressant and for Any Bupropion. Here, results reported for Bupropion alone. | |
| Research staff identify malformed subjects by reviewing hospital admission and discharge lists or from statewide birth-defect registries and mothers of non-malformed infants were identified at study hospitals and from a population-based random sample of newborns in Massachusetts. | |||||||||
|
Newport 2016 |
USA 1998 - 2012 nested case control |
The Emory Women’s Mental Health Program in Atlanta, Georgia. | Pregnant women diagnosed by their obstetrical care providers using ACOG– recommended diagnostic criteria for hypertensive disorders of pregnancy (HDP), including gestational hypertension, preeclampsia, eclampsia, or HELLP syndrome. | No history of hypertension. | Prospective documentation of medication exposure recording the daily dose of all agents on a week-by-week basis across gestation. | throughout pregnancy | 86 / 600 | Most study participants were treated with at least 1 psychotropic agent during pregnancy (n = 607, 88.5%) with antidepressant exposure the most frequent (n=489, 71.3%) => Non exposure considered as "exposed to other treatments". | |
| Outcome ascertainment was determined via structured abstraction of the obstetrical record by an experienced obstetrical nurse. | |||||||||
Risk of bias: : NA; : low; : moderate; : serious; : critical; : unclear;
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