Evidence map›Paper›PMID 21538146›Full record

Trial reportEuropean journal of clinical pharmacology2011

Buprenorphine versus methadone in pregnant opioid-dependent women: a prospective multicenter study.

Isabelle Lacroix, Alain Berrebi, Daniel Garipuy, Laurent Schmitt, Yamina Hammou, Catherine Chaumerliac, Maryse Lapeyre-Mestre, Jean-Louis Montastruc, Christine Damase-Michel

Registry-linked trialAbstract readClinical TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in European journal of clinical pharmacology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03098407 (A Pilot Randomized Comparative Effectiveness Clinical Trial of Buprenorphine vs. Methadone for the Treatment of Opioid Dependence in Pregnancy.), which is not on this map. Cited by 42 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed, 6 pooled it
12.2field-weighted citation impact, top 1% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT03098407 nacompletednot on this mapstarted 2017, after this paper: background citation

A Pilot Randomized Comparative Effectiveness Clinical Trial of Buprenorphine vs. Methadone for the Treatment of Opioid Dependence in Pregnancy.

TypeinterventionalSponsorUniversity of PittsburghRan2017 to 2020Enrolled55ConditionsOpioid-Related Disorders, PregnancyArmsBuprenorphine, Methadone
3 · Its place in the literature

Who cites it

42 citing papers in PubMed, 6 syntheses or guidelines pooled it, 91 citations in OpenAlex.

  1. Pooled it
  2. Maintenance agonist treatments for opiate-dependent pregnant women.The Cochrane database of systematic reviews · 2020
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  7. A comparison of cigarette smoking profiles in opioid-dependent pregnant patients receiving methadone or buprenorphine.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2013
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 5 institutions in 1 country.

Isabelle LacroixCentre Hospitalier Universitaire de Toulouse, Laboratoire de Pharmacologie Médicale et Clinique, Centre d'Evaluation et d'Information sur la Pharmacodépendance et d'Addictovigilance, INSERM U1027, Université de Toulouse, Toulouse, France. lacroix@cict.fr
Alain Berrebi
Daniel Garipuy
Laurent Schmitt
Yamina Hammou
Catherine Chaumerliac
Maryse Lapeyre-Mestre
Jean-Louis Montastruc
Christine Damase-Michel
Centre Hospitalier Universitaire de Toulouse · FRUniversité Fédérale de Toulouse Midi-Pyrénées · FRUniversité Toulouse III - Paul Sabatier · FRCentre Hospitalier Universitaire de Lille · FRHôpital Joseph-Ducuing · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

PATIENTS AND

methodsIn order to investigate the effects of exposure to buprenorphine compared with methadone during pregnancy, a prospective multicenter study was conducted in collaboration with maternity hospitals, maintenance therapy centers, and general practitioners involved in addiction care. Ninety pregnant women exposed to buprenorphine and 45 to metadone were selected for the study.

resultsDuring pregnancy, some women were exposed to illicit agents: cannabis (42% in the buprenorphine group vs. 58% in the methadone-treated group), heroin (17% vs. 44%), or cocaine (3% vs. 11%). Pregnancies ended in 85 vs. 40 live births, one vs. two stillbirths, two vs. one spontaneous abortion, two vs. one voluntary termination, and one vs. one medical termination in the buprenorphine and the methadone groups, respectively. Newborns had a birth weight of 2,892 ± 506 g (buprenorphine) vs. 2,731 ± 634 g (methadone) and a body length of 47.6 ± 2.5 cm vs. 47.1 ± 3 cm. 18.8% vs. 10% of newborns were delivered before 37 weeks of amenorrhea. Neonatal withdrawal syndrome occurred more frequently in the methadone group (62.5% vs. 41.2, p = 0.03). After adjustment for heroin exposure in late pregnancy, rates of neonatal withdrawal were no longer different between the methadone and buprenorphine groups. Twenty-one babies (84%) in the methadone group and 20 (57%) in the buprenorphine group (p = 0.03) required opiate treatment.

conclusionsWe did not observe more frequent malformations or cases of withdrawal syndrome in the buprenorphine group than in the methadone-treated group. Buprenorphine appears to be as safe as the currently approved substitute methadone considered to date as the reference treatment for pregnant opioid-dependent women.

Indexed as

AdultAnalgesics, OpioidBirth WeightBuprenorphineFemaleHeroinHeroin DependenceHumansInfant, NewbornMethadoneNarcoticsNeonatal Abstinence SyndromeOpiate Substitution TreatmentOpioid-Related DisordersPregnancyPregnancy ComplicationsAnalgesics, OpioidBuprenorphineHeroinMethadoneNarcotics

Identifiers

PMID21538146
OpenAlexW1990290956

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.