Propranolol (versus unexposed) - Medication and Pregnancy KB

Propranolol (versus unexposed)

Exposed non-exposed studies (cohort)

Study	Country Study period	Population source	Exposure definition	Non-exposure definition	Sample size	Rmk
Delteil, 2024	France 2004 - 2021	Pregnancies with a known outcome between July 2004 and December 2021 in Haute-Garonne, included in the EFEMERIS database.	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.	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.
Duan, 2018	USA 2003 - 2014	All singleton births in the Kaiser Permanente Southern California (KPSC) Region during the study period, with at least 1‐year enrollment of the Kaiser Permanente Health Plan within the year prior to the estimated date of delivery.	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.	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.
Ishibashi, 2017	Japan 2000 - 2016	Congenital long QT syndrome (LQTS)	Pregnancies in long QT patients with Propranolol therapy.	unexposed, sick Pregnancies in long QT patients without β-blocker therapy.	29 / 94	Exposure: 29 receiving propranolol (20–60mg, average: 40±14mg/day, 0.80±0.28mg/kg/day).
Lieberman, 1978	United Kingdom 1970 - 1973	Pregnancies complicated by maternal hypertension (diastolic blood pressure of 105 mm Hg or more at some point during pregnancy).	Pregnancies in hypertensive patients treated with propranolol and other hypotensive agents.	unexposed, sick Pregnancies in hypertensive patients treated with similar drugs excluding propranolol.	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.
Tanaka, 2016	Japan 2000 - 2010	Women with singleton pregnancies and with cardiovascular disease who delivered infants at 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.	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.

Case-control studies (cohort)

Study	Country Study period	Case	Control	Sample size	Rmk
Bergman, 2018	13 European countries (BE, CR, DE, DK, FR, IT, NO, SP, SW, UK) 1995 - 2013	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.	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).
Van Zutphen, 2014	USA 1997 - 2009	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.	2131 / 5129	Mothers reporting antihypertensive medications for the treatment of other indications (eg, b-blockers for migraine headaches) were excluded from the analyses.

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