Observational study of the safety of buprenorphine+naloxone in pregnancy in a rural and remote population

• Published in: BMJ open Vol. 6; no. 10; p. e011774
• Main Authors: Jumah, Naana Afua, Edwards, Craig, Balfour-Boehm, Jazmyn, Loewen, Kassandra, Dooley, Joseph, Gerber Finn, Lianne, Kelly, Len
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group LTD 31.10.2016; BMJ Publishing Group
• Subjects: Addiction; Adult; Age; Alcohol; Apgar Score; Birth Weight; Buprenorphine - adverse effects; Drug dosages; Female; Health risk assessment; Heroin; Humans; Infant, Newborn; Naloxone - adverse effects; Narcotic Antagonists - adverse effects; Narcotics; Neonatal Abstinence Syndrome - epidemiology; Ontario - epidemiology; Opioid-Related Disorders - epidemiology; Pregnancy; Pregnancy Complications - chemically induced; Pregnancy Complications - epidemiology; Pregnant Women - ethnology; Pregnant Women - psychology; Retrospective Studies; Rural Population - statistics & numerical data; Smoking; Stillbirth; Studies; Treatment Outcome; Urine; Ontario Canada; Canada; United States > US; Pregnancy; Rural and remote; Indigenous health; Safety; Buprenorphine + naloxone
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2016-011774

ObjectivesTo describe the effect of in utero exposure to the buprenorphine+naloxone combination product in a rural and remote population.SettingA district hospital that services rural and remote, fly-in communities in Northwestern Ontario, Canada.ParticipantsA retrospective cohort study was conducted of 855 mother infant dyads between 1 July 2013 and 30 June 2015. Cases included all women who had exposure to buprenorphine+naloxone during pregnancy (n=62). 2 control groups were identified; the first included women with no opioid exposure in pregnancy (n=618) and the second included women with opioid exposure other than buprenorphine+naloxone (n=159). Women were excluded if they had multiple pregnancy or if they were part of a methadone programme (n=16). The majority of women came from Indigenous communities.OutcomesThe primary outcomes were birth weight, preterm delivery, congenital anomalies and stillbirth. Secondary neonatal outcomes included gestational age at delivery, Apgar scores at 1 and 5 min, NAS Score >7 and treatment for neonatal abstinence syndrome (NAS). Secondary maternal outcomes included the number of caesarean sections, postpartum haemorrhages, out of hospital deliveries and transfer of care to tertiary centres.ResultsNo difference was found in the primary outcomes or in the Apgar score and caesarean section rate between in utero buprenorphine+naloxone exposure versus no opioid exposure in pregnancy. Compared to women taking other opioids, women taking buprenorphine+naloxone had higher birthweight babies (p=0.001) and less exposure to marijuana (p<0.001) during pregnancy.ConclusionsRetrospective data suggest that there likely is no harm from taking buprenorphine+naloxone opioid agonist treatment in pregnancy. Larger, prospective studies are needed to further assess safety.