| 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 |
|---|---|---|---|---|---|---|---|---|
|
Albertini 2023 |
Canada 2012 - 2021 retrospective cohort |
The tertiary Pregnancy and Heart Disease Program at the University of Toronto, Canada. | Babies born to mothers with long QT syndrome who had taken Metoprolol during pregnancy. |
unexposed, sick
Babies born to mothers with long QT syndrome who had not taken beta-blockers during pregnancy. |
during pregnancy (anytime or not specified) | 16 / 7 | ||
| Maternal clinical history including medications was collected (no other details). | ||||||||
|
Bateman 2016 |
USA 2003 - 2007 retrospective cohort (claims database) |
The US Medicaid Analytic eXtract (MAX). | Maternal consumption of Metoprolol at the time of delivery, i.e prescriptions that were filled between 5 months after the last menstrual period and the day of delivery. |
unexposed, sick
Pregnant patients without any β blocker exposure at the time of delivery, notably matched on the preexisting hypertension. |
late pregnancy | 1484 / 4452 | ||
| Claims database of dispensed prescriptions for outpatient medications. | ||||||||
|
Delteil 2024 |
France 2004 - 2021 retrospective cohort (claims database) |
EFEMERIS (Évaluation chez la Femme Enceinte des MÉdicaments et de leurs RISques) database, and the Registre des Handicaps de l'Enfant en Haute-Garonne (RHE31), Haute-Garonne, France. | Pregnancies with at least one dispensed prescription of Metoprolol during pregnancy (between last menstrual period and delivery). |
unexposed (general population or NOS)
Pregnancies without dispensed prescription of beta-blockers and other anti-hypertensive agents during pregnancy. |
at least 1st trimester | 65 / 172284 | When available, data in women with chronic pathology (hypertension or cardiac), treated at least during the 1st trimester were preferred to all indications (including gestational hypertension, ...). Exposure at least T1 considered as chronic indications. | |
| Women's drug exposure during pregnancy was estimated on the basis of dispensed prescription drugs recorded by the French Assurance Maladie. | ||||||||
|
Duan 2018 |
USA 2003 - 2014 retrospective cohort (claims database) |
The Kaiser Permanente Southern California (KPSC) Region. | Pregnant patients that filled a prescription for Metoprolol between their estimated conception date and the date of delivery. |
unexposed (general population or NOS)
Pregnant women who were not exposed to beta‐blockers at any time during their pregnancy. |
during pregnancy (anytime or not specified) | 324 / 374391 | The 4 most prescribed beta‐blockers were labetalol (n = 3357), atenolol (n = 638), propranolol (n = 489), and metoprolol (n = 324). Health plan members have a demographic and socioeconomic profile similar to the overall southern California population. | |
| Pregnant women exposed to beta‐blockers during their pregnancy were identified using pharmacy dispensing records. | ||||||||
|
Tanaka 2016 |
Japan 2000 - 2010 retrospective cohort |
The National Cerebral and Cardiovascular Center in Osaka, Japan. | Pregnant women with cardiovascular disease treated with Metoprolol for at least 2 weeks before delivery. |
unexposed, sick
Pregnant women with cardiovascular disease who were not treated with an oral α/β- or β-adrenergic blocker randomly identified over the same period. |
during pregnancy (anytime or not specified) | 12 / 100 | Maternal cardiovascular diseases: congenital heart disease and pulmonary hypertension; aortic disease; valvular heart disease; coronary artery disease and acute coronary syndrome; cardiomyopathy and heart failure; and arrhythmia. | |
| Patient data were collected from their medical records and included medication(s) used (β-blockers and other ones). | ||||||||
|
Vaclavik 2024 |
The Czech Republic 2012 - 2022 population based cohort retrospective |
The National Registry of Reproductive Health (NRRZ) and the National Registry of Reimbursable Health Services (NRHZS). | Births whose mothers were prescribed Metoprolol during pregnancy (for pre-existing hypertension or pregnancy-induced hypertension). |
unexposed, disease free
Births whose mothers had no hypertension. |
during pregnancy (anytime or not specified) | -9 / -9 | ||
| The National Registry of Reimbursable Health Services (NRHZS). | ||||||||
| Study | Country Study period Study design |
Data source | Case | Control | Exposition | Exposition period | Sample size (exposed/unexposed) Or (case / control) |
Remarks | Risk of bias |
|---|---|---|---|---|---|---|---|---|---|
|
Puho 2007 |
Hungary 1980–1996 case control |
Hungarian Case-Control Surveillance of Congenital Abnormalities | Cases with isolated cleft lip with or without cleft palate (CL/P) and posterior cleft palate (PCP). | Newborn infants without congenital abnormalities | Mothers were asked to send their prenatal maternity logbook and other medical records and they were mailed a questionnaire. Regional nurses were asked to visit and question the non-respondent. | 1st trimester | 1975 / 38151 | ||
| Notification by physicians to the Hungarian Congenital Abnormality Registry. Pathologists sent a copy of each autopsy report to the registry for stillborn fetuses or infant deaths and defect diagnosed in prenatal diagnostic centers with or without termination of pregnancy were included. | |||||||||
|
Van Zutphen 2014 |
USA 1997 - 2009 case control |
The National Birth Defects Prevention Study, USA. | All cases (liveborn, stillborn after 20 weeks gestation, or induced abortions) with severe hypospadias (ie, subcoronal or penile, scrotal, or perineal meatal opening) diagnosed at the time of physical examination, surgery, or autopsy. | Male live births without birth defects randomly selected from birth certificates or hospital discharge listings in the same population as the case neonates. | Antihypertensive medication use were collected by trained interviewers who conducted maternal telephone interviews within 24 months of delivery. | early pregnancy | 2131 / 5129 | Mothers reporting antihypertensive medications for the treatment of other indications (eg, b-blockers for migraine headaches) were excluded from the analyses. | |
| Data were abstracted from medical record, birth certificates or hospital discharge records. To confirm cases, clinical geneticists reviewed data, including consultations (urology, endocrinology, and genetic), reports (operative, pathology, and autopsy), and radiographic results. | |||||||||
Risk of bias: : NA; : low; : moderate; : serious; : critical; : unclear;
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