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B-Blocker Treatment During Pregnancy and Adverse Pregnancy Outcomes: a Nationwide Population-Based Cohort Study

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B-Blocker Treatment During Pregnancy and Adverse Pregnancy Outcomes: a Nationwide Population-Based Cohort Study Open Access Research BMJ Open: first published as 10.1136/bmjopen-2012-001185 on 19 July 2012. Downloaded from b-Blocker treatment during pregnancy and adverse pregnancy outcomes: a nationwide population-based cohort study Kasper Meidahl Petersen,1 Espen Jimenez-Solem,1 Jon Traerup Andersen,1 Morten Petersen,1 Kasper Brødbæk,1 Lars Køber,2 Christian Torp-Pedersen,3 Henrik Enghusen Poulsen1 To cite: Meidahl Petersen K, ABSTRACT ARTICLE SUMMARY Jimenez-Solem E, Objective: To investigate the association between et al b Andersen JT, . -Blocker exposure to b-blockers during pregnancy and the risk Article focus treatment during pregnancy of being born small for gestational age (SGA), preterm - and adverse pregnancy There is contradictory evidence concerning the birth and perinatal mortality in a nationwide cohort. b outcomes: a nationwide consequences of -blocker treatment during population-based cohort Design: A population-based retrospective cohort pregnancy. study. BMJ Open 2012;2: study, using the Danish Fertility Database. The authors - This survey explores the effects of b-blocker e001185. doi:10.1136/ identified all pregnant women redeeming a prescription exposure during pregnancy in a Danish birth bmjopen-2012-001185 for b-blockers using the National Prescription cohort comprising all births in Denmark between Registry. Multivariate logistic regression models were 1995 and 2008. In addition, we compared risks < Prepublication history for used to assess the association between exposure and associated with exposure to labetalol with this paper is available online. our outcomes. b To view this file please visit exposure to other -blockers. Setting: Register-based survey. the journal online Key messages (http://dx.doi.org/10.1136/ Participants: 911’685 births between 1995 and 2008 - Redeeming prescriptions of b-blockers was bmjopen-2012-001185). obtained from the Danish Fertility Database. found to be significantly associated with http://bmjopen.bmj.com/ Outcome measures: Being born SGA was defined as increased risk of being born SGA, preterm birth Received 20 March 2012 having a birth weight below the 10th percentile for the and perinatal mortality. Accepted 27 June 2012 corresponding gestational week. Preterm birth was - We found comparable risk profiles in labetalol- defined as birth before the 37th gestational week. This final article is available exposed pregnancies and in pregnancies Perinatal mortality was defined as either death for use under the terms of exposed to any other b-blocker. the Creative Commons occurring within the first 28 days of life or stillbirth. Attribution Non-Commercial Before 2004, fetal deaths were recorded as stillbirths if Strengths and limitations of this study 2.0 Licence; see they occurred after 28 weeks of gestation, but since - This study is the largest of its kind to date and http://bmjopen.bmj.com then stillbirth is recorded for deaths after 22 covers an entire nation, which minimises risk of on September 27, 2021 by guest. Protected copyright. gestational weeks. selection bias. Results: The authors identified 2459 pregnancies - Given the study design, we were not able to exposed to b-blockers. b-Blocker exposure during adjust for treatment indication and severity of pregnancy was found to be associated with increased maternal disease nor were we able to rule out risk of SGA (adjusted OR 1.97, 95% CI 1.75 to 2.23), confounding by indication, the underlying preterm birth (adjusted OR 2.26, 95% CI 2.03 to 2.52) maternal disease, as a possible explanation for and perinatal mortality (adjusted OR 1.89, 95% CI 1.25 our findings. 1Department of Clinical to 2.84). Analyses were adjusted for socioeconomic Pharmacology, Q, Rigshospitalet, University and maternal variables. The authors found similar risk Hospital Copenhagen, profiles for pregnancies exposed to labetalol and for INTRODUCTION b Copenhagen, Denmark pregnancies exposed to other -blockers. b-Blockers are widely used in the treatment of 2 e Department of Cardiology, Conclusions: The authors found that exposure to chronic hypertension,1 4 migraine,5 essential Rigshospitalet, University b -blockers during pregnancy was associated with tremor6 and various other conditions. There Hospital Copenhagen, being born SGA, preterm birth and perinatal mortality. is contradictory evidence concerning the Copenhagen, Denmark Our findings show that labetalol is not safer than other 3 b Department of Cardiology, b-blockers during pregnancy. consequences of -blocker treatment during Gentofte Hospital, Gentofte, pregnancy. Some studies report an associa- Denmark tion between b-blocker treatment and small- Correspondence to for-gestational-age (SGA) newborns and 47e10 211 Kasper Meidahl Petersen; preterm birth, while others do not. [email protected] Preterm birth and being born SGA are Meidahl Petersen K, Jimenez-Solem E, Andersen JT, et al. BMJ Open 2012;2:e001185. doi:10.1136/bmjopen-2012-001185 1 Adverse pregnancy outcomes after exposure to b-blockers during pregnancy BMJ Open: first published as 10.1136/bmjopen-2012-001185 on 19 July 2012. Downloaded from associated with increased risk of perinatal mortality.12 13 of these prescriptions had to be redeemed between We set out to investigate whether the use of b-blockers conception and the 20th week of gestation. during pregnancy was associated with being born SGA, We assessed exposure to b-blockers by identifying preterm birth and perinatal mortality in a nationwide redeemed prescriptions with ATC code C07. Furthermore, survey between 1995 and 2008. we identified the most frequently redeemed b-blockers in Denmark: labetalol (C07AG01), metoprolol (C07AB02), METHODS atenolol (C07AB03), propranolol (C07AA05), pindolol Study population (C07AA03) and sotalol (C07AA07). Fewer than 50 preg- We used data obtained from three nationwide registries: nancies were exposed to any of the remaining b-blockers. the Danish Fertility Database,14 the Danish National We divided b-blocker exposure into exposure to labe- Hospital Register15 and the National Prescription talol and exposure to other b-blockers. The latter group Register.16 Data concerning income and educational was formed because there were few redeemed prescrip- level were obtained, respectively, from the Income tions of individual b-blockers other than labetalol. We Statistics Register17 and the Danish Education Register,18 compared risks associated with exposure to b-blockers both of which are provided by Statistics Denmark. In with exposure to methyldopa (C02AB01, C02AB02), Denmark, all citizens are given a unique 10-digit identi- calcium channel blockers (C08C) and ACE inhibitors fication number at birth.19 This number can be used to (C09A) to assess possible confounding by indication. link information between nationwide registers. Maternal diabetes mellitus was defined as redeeming Using the Danish Fertility Database, we identified a prescription for insulin or an insulin analogue (ATC 974 805 births between 1995 and 2008. We removed code A10A). Furthermore, we assessed comedication 52 603 records lacking information on pregnancy dura- with statins (ATC code C10) and antiobesity drugs (ATC tion and 7681 records with coding errors. In addition, we code A08A). We identified pregnant women redeeming excluded 2836 records with pregnancy-induced hyper- prescriptions with these drugs in order to adjust for tension, defined as having redeemed an antihyperten- diabetes mellitus, obesity and statin use since these sive drug prescription after the 20th week of gestation, women have different risk profiles for the defined but never before. The final study population thus outcomes. comprised 911 685 births. The Danish Fertility Database contains information on Definition of outcomes maternal age, date of birth and previous births, as well as Being born SGA was defined as having a birth weight on each child’s sex, gestational age, weight and below the 10th percentile for the corresponding gesta- mortality.14 tional week. Preterm birth was defined as birth before Time of conception is based on ultrasound estimates the 37th gestational week. Perinatal mortality was http://bmjopen.bmj.com/ in early pregnancy or information on last menstrual defined as either death occurring within the first 28 days period. of life or stillbirth. Before 2004, fetal deaths were Information on redeemed prescriptions was retrieved recorded as stillbirths if they occurred after 28 weeks of from the National Prescription Register, which holds gestation, but since then stillbirth is recorded for deaths information on date of redemption, quantity, strength after 22 gestational weeks.20 and form.16 Drugs are coded in accordance with the Anatomical Therapeutic Chemical (ATC) classification. Statistical analyses The Danish National Hospital Register contains Data were managed and analysed using SAS V.9.2 (SAS on September 27, 2021 by guest. Protected copyright. information on diagnoses of somatic admissions and Institute Inc.). Logistic regression models were devel- outpatients at all Danish hospitals since 197715 in oped for dichotomous variables adjusted for maternal accordance with the Danish revision of the 10th Inter- age, year of conception, annual household income, national Classification of Diseases system. We used parity and educational level (model 1). Maternal age was < e e e primary discharge diagnoses and disregarded secondary divided into five groups: 20, 21 25, 26 30, 31 35 and > diagnoses because secondary diagnoses in general are 35 years (no missing values). Annual household not validated. We identified
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