| 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 |
|---|---|---|---|---|---|---|---|---|
|
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 Carvedilol 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 | 1 / 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. | ||||||||
|
Kubota - Carvedilol 2023 |
Japan 2014 - 2020 retrospective cohort |
Not specified. | Pregnancies in women with heart disease who were prescribed α/β-blocker (i.e carvedilol). |
unexposed, sick
Pregnancies in women with heart disease who did not take any of the α/β- blockers and β-blockers. |
during pregnancy (anytime or not specified) | 32 / 263 | ||
| This was a retrospective analysis of data collected for routine clinical care. The patients were identified based on their prescription histories, and their hospital records were examined. | ||||||||
|
Tanaka 2016 |
Japan 2000 - 2010 retrospective cohort |
The National Cerebral and Cardiovascular Center in Osaka, Japan. | Pregnant women with cardiovascular disease treated with an oral α/β-adrenergic blocker (carvedilol) 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) | 13 / 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). | ||||||||
| 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;
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