Confounding of the Comparative Safety of Prenatal Opioid Agonist Therapy

Brogly, Susan B.; Hahn, Kristen A.; Diaz, Sonia Hernandez; Werler, Martha M.

doi:10.4172/2155-6105.1000252

Cited by 14 publications

(16 citation statements)

References 31 publications

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“…performed an adjusted analysis the differences disappeared 11. Indeed, only few studies comparing the safety of B versus M on the neonate adjust for confounding 39.…”

Section: Discussionmentioning

confidence: 99%

Neonatal outcomes after fetal exposure to methadone and buprenorphine: national registry studies from the Czech Republic and Norway

et al. 2018

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Background and AimsOpioid maintenance treatment (OMT) is recommended to opioid‐dependent females during pregnancy. However, it is not clear which medication should be preferred. We aimed to compare neonatal outcomes after prenatal exposure to methadone (M) and buprenorphine (B) in two European countries.DesignNation‐wide register‐based cohort study using personalized IDs assigned to all citizens for data linkage.SettingThe Czech Republic (2000–14) and Norway (2004–13). [Correction added after online publication on 26 April 2018: The Czech Republic (2000–04) corrected to (2000–14).]ParticipantsOpioid‐dependent pregnant Czech (n = 333) and Norwegian (n = 235) women in OMT who received either B or M during pregnancy and their newborns.MeasurementsWe linked data from health registries to identify the neonatal outcomes: gestational age, preterm birth, birth weight, length and head circumference, small for gestational age, miscarriages and stillbirth, neonatal abstinence syndrome (NAS) and Apgar score. We performed multivariate linear regression and binary logistic regression to explore the associations between M and B exposure and outcomes. Regression coefficient (β) and odds ratio (OR) were computed.FindingsMost neonatal outcomes were more favourable after exposure to B compared with M, but none of the differences was statistically significant. For instance, in the multivariate analysis, birth weight was β = 111.6 g [95% confidence interval (CI) = −10.5 to 233.6 and β = 83.1 g, 95% CI = −100.8 to 267.0] higher after B exposure in the Czech Republic and Norway, respectively. Adjusted OR of NAS for B compared with M was 0.94 (95% CI = 0.46–1.92) in the Norwegian cohort.ConclusionsTwo national cohorts of women receiving opioid maintenance treatment during pregnancy showed small but not statistically significant differences in neonatal outcomes in favour of buprenorphine compared with methadone.

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“…performed an adjusted analysis the differences disappeared 11. Indeed, only few studies comparing the safety of B versus M on the neonate adjust for confounding 39.…”

Section: Discussionmentioning

confidence: 99%

Neonatal outcomes after fetal exposure to methadone and buprenorphine: national registry studies from the Czech Republic and Norway

et al. 2018

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“…Potential confounding by indication can occur in assessing the comparative outcomes of prenatal BMT versus MMT because maternal characteristics that might influence choice of prenatal treatment with BMT versus MMT likely also affect neonatal outcomes [13, 14]. Prior studies have suggested improved NAS and birth outcomes in neonates exposed to buprenorphine compared to methadone, including decreased NAS severity with shorter length of hospitalization, lower risk of NAS pharmacologic treatment, and higher gestational age at birth, birth weight, body length and head circumference [15–17].…”

Section: Discussionmentioning

confidence: 99%

Prenatal treatment for opioid dependency: observations from a large inner-city clinic

Saia

Bagley

Wachman

et al. 2017

Addict Sci Clin Pract

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BackgroundThe objective of this study was to review changes in the prevalence of opioid use disorder in pregnancy, and to describe the prenatal care and neonatal outcomes following the implementation of buprenorphine treatment at a large US obstetrical clinic during the on-going opioid epidemic. MethodsWe conducted a retrospective cohort study of 310 women (332 pregnancies) with opioid use disorders and their neonates delivered between June 2006 and December 2010 at an obstetrical clinic in the US. Trends in patient volume, characteristics and outcomes by calendar year were assessed using the Cochran–Armitage test and linear regression.ResultsThere was an almost two-fold increase in the volume of pregnant women treated annually from 2006 through 2010. Most women were treated with methadone (74%), with buprenorphine becoming more common over calendar time: 3.0% in 2006 to 41% in 2010. The mean dose of buprenorphine at delivery was: 11.4 mg in 2007, 14.1 mg in 2008, 14.1 mg in 2009, and 16.8 mg in 2010; an average increase of 2.1 mg year. There were no differences in mean methadone dose over time. From 2006 to 2010 there were increases in the prevalence of prescribed concomitant psychotropic medications and vaginal deliveries, and in the proportion of neonates treated pharmacologically for neonatal abstinence syndrome (NAS). NAS pharmacologic management also varied by calendar year with more use of neonatal morphine and clonidine in later years.ConclusionsThe number of mother–infant pairs increased significantly from 2006 to 2010 and the clinical characteristics of these patients changed over time. Our experience reflects the rising increase in opioid use disorders in pregnancy and NAS, mandating the need for expansion of comprehensive prenatal care options for these women and their children.

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“…However, differences in pregnancy outcomes between women treated with methadone vs. BPN need to be considered in light of the possible role of unmeasured confounding. For example, the choice of opioid agonist therapy may be influenced by maternal characteristics, including comorbidities, continued illicit opioid use, or concurrent use of psychotropic medications . Regardless of whether methadone or BPN is prescribed, clinicians treating pregnant women with opioid dependence should be mindful of the high prevalence of psychiatric comorbidities in this population, as increased severity of NAS has been observed with concurrent exposure to benzodiazepines and antidepressants …”

Section: Methodsmentioning

confidence: 99%

Medication Use and Pain Management in Pregnancy: A Critical Review

Black¹,

Khor

Kennedy

et al. 2019

Pain Practice

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Background Pain during pregnancy is common, and its management is complex. Certain analgesics may increase the risk for adverse fetal and pregnancy outcomes, while poorly managed pain can result in adverse maternal outcomes such as depression and hypertension. Guidelines to assist clinicians in assessing risks and benefits of exposure to analgesics for the mother and unborn infant are lacking, necessitating evidence‐based recommendations for managing pain in pregnancy. Methods A comprehensive literature search was conducted to assess pregnancy safety data for pharmacological and nonpharmacological pain management methods. Relevant clinical trials and observational studies were identified using multiple medical databases, and included studies were evaluated for quality and possible biases. Results Paracetamol and nonsteroidal anti‐inflammatory drugs (NSAIDs) are appropriate for mild to moderate pain, but NSAIDs should be avoided in the third trimester due to established risks. Short courses of weaker opioids are generally safe in pregnancy, although neonatal abstinence syndrome must be monitored following third trimester exposure. Limited safety data for pregabalin and gabapentin indicate that these are unlikely to be major teratogens, and tricyclic antidepressants and serotonin‐norepinephrine reuptake inhibitors have limited but overall reassuring safety data. Many of the included studies were limited by methodological issues. Conclusions Findings from this review can guide clinicians in their decision to prescribe analgesics for pregnant women. Treatment should be tailored to the lowest therapeutic dose and shortest possible duration, and management should involve a discussion of risks and benefits and monitoring for response. Further research is required to better understand the safety profile of various analgesics in pregnancy.

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Confounding of the Comparative Safety of Prenatal Opioid Agonist Therapy

Cited by 14 publications

References 31 publications

Neonatal outcomes after fetal exposure to methadone and buprenorphine: national registry studies from the Czech Republic and Norway

Neonatal outcomes after fetal exposure to methadone and buprenorphine: national registry studies from the Czech Republic and Norway

Prenatal treatment for opioid dependency: observations from a large inner-city clinic

Medication Use and Pain Management in Pregnancy: A Critical Review

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