| 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 Propranolol 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, during pregnancy (anytime or not specified) | 599 / 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 Propranolol 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) | 489 / 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. | ||||||||
|
Ishibashi 2017 |
Japan 2000 - 2016 retrospective cohort |
15 Japanese institutions. | Pregnancies in long QT patients with Propranolol therapy. |
unexposed, sick
Pregnancies in long QT patients without β-blocker therapy. |
during pregnancy (anytime or not specified) | 29 / 94 | Exposure: 29 receiving propranolol (20–60mg, average: 40±14mg/day, 0.80±0.28mg/kg/day). | |
| All data were collected with checking their maternity record book. | ||||||||
|
Lieberman 1978 |
United Kingdom 1970 - 1973 retrospective cohort |
Not specified. | Pregnancies in hypertensive patients treated with propranolol and other hypotensive agents. |
unexposed, sick
Pregnancies in hypertensive patients treated with similar drugs excluding propranolol. |
during pregnancy (anytime or not specified) | 9 / 15 | Pentolinium, clonidine and hydrallazine had been prescribed for so few patients (one, one and three respectively) that they were excluded from the analysis. | |
| Not specified. | ||||||||
|
Tanaka 2016 |
Japan 2000 - 2010 retrospective cohort |
The National Cerebral and Cardiovascular Center in Osaka, Japan. | Pregnant women with cardiovascular disease treated with Propranolol 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) | 22 / 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 |
|---|---|---|---|---|---|---|---|---|---|
|
Bergman 2018 |
13 European countries (BE, CR, DE, DK, FR, IT, NO, SP, SW, UK) 1995 - 2013 case control |
EUROmediCAT network of 17 European Concerted Action on Congenital Anomalies and Twins (EUROCAT) registries participating in EUROmediCAT. | Registrations with a specific congenital anomaly or anomaly subgroups (reported in the literature or not). | All other EURO-mediCAT registrations with a non-chromosomal non-signal anomaly group. | Medication exposure was obtained from the mother’s medical files (mostly these are only files relating to the pregnancy) and from the child’s, except for the Tuscany registry, which only collects data on medication use via a questionnaire sent to the mother after birth of the malformed child. | 1st trimester | 49243 / 50709 | Non selective beta-blockers: mainly Propranolol (50/52). 2 available controls: non-chromosomal non-signal anomaly group and a chromosomal anomaly group => use of the 1st one (more pregnancies; same control group for signal and exploratory analysis). | |
| EUROCAT registries collect data on all pregnancy outcomes: live births, foetal deaths >= 20 weeks of gestational age (including stillbirths) and terminations of pregnancy for foetal anomalies (TOPFAs) with a major congenital anomaly. | |||||||||
|
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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