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Infections and obstetric outcomes in opioid-dependent pregnant women maintained on methadone or buprenorphine.

ABSTRACT: To characterize infections and compare obstetric outcomes in opioid-dependent pregnant women who participated in a randomized clinical trial comparing agonist medications, methadone and buprenorphine.Incidence of infections was identified as part of the screening medical assessment. As part of a planned secondary analysis, analysis of variance and polytomous logistic regressions were conducted on obstetric outcome variables using treatment randomization condition (maternal maintenance with either methadone or buprenorphine) as the predictor variable, controlling for differences between study sites.Six United States sites and one European site that provided comprehensive treatment to opioid-dependent pregnant women.Pregnant opioid-dependent women (n = 131) who delivered while participating in the Maternal Opioid Treatment: Human Experimental Research (MOTHER) study.Obstetric, infectious and other maternal medical complications captured by medical records, physical examination, blood tests and self-report. Neonatal medical complications captured by medical records.Hepatitis C was the most common infection (32.3%), followed by hepatitis B (7.6%) and chlamydia (6.1%) among participants at study enrollment. Maternal methadone versus buprenorphine maintenance was associated with a higher incidence of preterm labor (P = 0.04) and a significantly higher percentage of signs of respiratory distress in neonates at delivery (P = 0.05). Other medical and obstetric complications were infrequent in the total sample, as well as in both methadone and buprenorphine conditions.Buprenorphine appears to have an acceptable safety profile for use during pregnancy.

SUBMITTER: Holbrook AM

PROVIDER: S-EPMC4368056 | biostudies-literature | 2012 Nov

REPOSITORIES: biostudies-literature

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Infections and obstetric outcomes in opioid-dependent pregnant women maintained on methadone or buprenorphine.

Holbrook Amber M AM Baxter Jason K JK Jones Hendrée E HE Heil Sarah H SH Coyle Mara G MG Martin Peter R PR Stine Susan M SM Kaltenbach Karol K

Addiction (Abingdon, England) 20121101

<h4>Aims</h4>To characterize infections and compare obstetric outcomes in opioid-dependent pregnant women who participated in a randomized clinical trial comparing agonist medications, methadone and buprenorphine.<h4>Design</h4>Incidence of infections was identified as part of the screening medical assessment. As part of a planned secondary analysis, analysis of variance and polytomous logistic regressions were conducted on obstetric outcome variables using treatment randomization condition (mat ...[more]

PMID: 23106930

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Project description:BACKGROUND:Naloxone is the usual drug used in opioid-induced respiratory depression but it has a short half-life, precipitates withdrawal in dependent patients, and thus for persistent reversal of long-acting opioids has to be given by titrated doses and infusions. The partial agonist buprenorphine has a much longer duration of action and causes less severe withdrawal, but still should largely reverse respiratory depression induced by full agonist opioids. We aimed to compare the efficacy/safety of buprenorphine and naloxone in reversing respiratory depression in methadone-poisoned opioid-dependent patients. METHODS:Patients with methadone-induced respiratory depression were randomized to receive naloxone (titrated doses), or lower or higher doses of buprenorphine (10??g/kg or 15??g/kg). The primary outcome was immediate reversal of respiratory depression. We also recorded acute opioid withdrawal, need for intubation/recurrent apnea, repeated doses of opioid antagonists, length of hospital stay, other morbidity, and mortality. The study was registered with the Iranian Registry of Clinical Trials (Trial ID: 18265; Approval code: IRCT2015011020624N1). RESULTS:Eighty-five patients were randomized; 55/56 patients who received buprenorphine had rapid reversal of respiratory depression, which persisted for at least 12?h. Naloxone was effective in 28/29 patients, but often required very high titrated doses (thus delaying time to respond) and prolonged infusions. Intubation (8/29 vs 5/56) and opioid withdrawal (15/29 vs 7/56) were less common with buprenorphine. There were no serious complications or deaths in those receiving buprenorphine. The 15-?g/kg buprenorphine dose appeared to provide a longer duration of action, but precipitated withdrawal more frequently than the 10-?g/kg dose. CONCLUSION:Buprenorphine appears to be a safe and effective substitute for naloxone in overdosed opioid-dependent patients. Further studies are warranted to explore the optimal dosing strategy for buprenorphine to consistently maintain reversal of respiratory depression but not precipitate withdrawal. TRIAL REGISTRATION NUMBER:IRCT2015011020624N1. Registered 30 September 2015.

Dataset Information

Infections and obstetric outcomes in opioid-dependent pregnant women maintained on methadone or buprenorphine.

Publications

Infections and obstetric outcomes in opioid-dependent pregnant women maintained on methadone or buprenorphine.

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