Observational studyBMJ open2016
Observational study of the safety of buprenorphine+naloxone in pregnancy in a rural and remote population.
Observational study in BMJ open, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03740243 (Comparison of Buprenorphine vs Buprenorphine/Naloxone on the Effects of Maternal Symptomatology), which is not on this map. Cited by 18 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Comparison of Buprenorphine vs Buprenorphine/Naloxone on the Effects of Maternal Symptomatology
Who cites it
18 citing papers in PubMed, 2 syntheses or guidelines pooled it, 46 citations in OpenAlex.
- Opioid exposure during pregnancy and the risk of congenital malformation: a meta-analysis of cohort studies.BMC pregnancy and childbirth · 2022Pooled it
- Guideline
- A Structural Examination of Racial Differences in Pharmacologic Treatment Among Opioid Exposed Infants.Journal of racial and ethnic health disparities · 2026Article
- Safety and Efficacy of Buprenorphine-Naloxone in Pregnancy: A Systematic Review of the Literature.Pathophysiology : the official journal of the International Society for Pathophysiology · 2023Review
- Addiction in the family: Two Indigenous families overcoming barriers to opioid agonist therapy.Canadian family physician Medecin de famille canadien · 2022Article
- Article
- On the path to reclaiming Indigenous midwifery: Co-creating the Maternal Infant Support Worker pilot program.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2021Article
- Buprenorphine dosing for the treatment of opioid use disorder through pregnancy and postpartum.Current treatment options in psychiatry · 2020Article
- Medication treatment for opioid use disorder in expectant mothers (MOMs): Design considerations for a pragmatic randomized trial comparing extended-release and daily buprenorphine formulations.Contemporary clinical trials · 2020Article
- Long-term treatment retention in West Virginia's comprehensive opioid addiction treatment (COAT) program.Journal of the neurological sciences · 2020Review
- West Virginia's model of buprenorphine expansion: Preliminary results.Journal of substance abuse treatment · 2020Article
- Neonatal abstinence syndrome.Nature reviews. Disease primers · 2018Review
- Treating women with opioid use disorder during pregnancy in Appalachia: Initial neonatal outcomes following buprenorphine + naloxone exposure.The American journal on addictions · 2018Article
- Opioid use in pregnancy and parenting: An Indigenous-based, collaborative framework for Northwestern Ontario.Canadian journal of public health = Revue canadienne de sante publique · 2018Article
- Suboxone: Rationale, Science, Misconceptions.Ochsner journal · 2018Article
- First Nations hepatitis C virus infections: Six-year retrospective study of on-reserve rates of newly reported infections in northwestern Ontario.Canadian family physician Medecin de famille canadien · 2017Article
- Article
- Successful Buprenorphine/Naloxone Low-dose Induction in Pregnancy: A Case Report.Journal of addiction medicineArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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. 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.
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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.