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

Abstract:

OBJECTIVES:To describe the effect of in utero exposure to the buprenorphine+naloxone combination product in a rural and remote population. SETTING:A district hospital that services rural and remote, fly-in communities in Northwestern Ontario, Canada. PARTICIPANTS:A 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. OUTCOMES:The 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. RESULTS:No 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. CONCLUSIONS:Retrospective 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.

journal_name

BMJ Open

journal_title

BMJ open

authors

Jumah NA,Edwards C,Balfour-Boehm J,Loewen K,Dooley J,Gerber Finn L,Kelly L

doi

10.1136/bmjopen-2016-011774

subject

Has Abstract

pub_date

2016-10-31 00:00:00

pages

e011774

issue

10

issn

2044-6055

pii

bmjopen-2016-011774

journal_volume

6

pub_type

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