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The Impact of Methadone Maintenance Treatment During Pregnancy on Perinatal Outcomes Cleary BJ, Donnelly J, Strawbridge J, Gallagher PJ, Fahey T, Murphy DJ. Brian J Cleary HRB PhD Scholar, Health Services Research School of Pharmacy, Royal College of Surgeons in Ireland Background • Methadone maintenance- current treatment of choice for pregnant opiate-dependent women • Few studies have compared perinatal outcomes in methadone-exposed and non-exposed pregnancies • Neonatal abstinence syndrome (NAS) develops in 40-90% of neonates exposed to methadone in utero • Results of studies of relationship between methadone dose and NAS have been equivocal Aims • Compare the likelihood of adverse perinatal outcomes in methadone exposed and unexposed pregnancies • Explore the determinants of the occurence of neonatal abstinence syndrome (NAS) in methadone-exposed neonates Methods • Based on electronic records of 61043 singleton pregnancies delivered Jan 2000 and Dec 2007 • Methadone exposure recorded prospectively by a midwife during pregnancy before perinatal outcomes known – At booking interview – At admission to delivery suite if unbooked • Other sources of ascertainment: – Controlled drug registers – Hospital prescription records • Research protocol approved by CWIUH REC Methods Main Study Variables • Maternal sociodemographic, medical and obstetric characteristics • Methadone dose at delivery • Perinatal outcomes • Objective NAS diagnosis- modified Finnegan scoring system Methods Statistical Analysis Univariable and multivariable logistic regression used to determine crude and adjusted odds ratios and 95% confidence intervals for the association between: – methadone exposure and maternal characteristics – methadone exposure and maternal/perinatal outcomes – methadone dose and occurrence of NAS Results Maternal Characteristics • Methadone was used at delivery in 618 (1%) pregnancies • Methadone use at delivery was more likely in women who were: – – – – – – – – – – Younger Unemployed or manual workers Irish Non-married Multiparous Had an unplanned pregnancy Late bookers Public patients Smokers Heavy drinkers (>14 units/week) Results Perinatal Outcomes • Methadone use was associated with adverse perinatal outcomes: – Preterm birth (<37 weeks) – Small for gestational age (<10th centile) – Admission to neonatal unit – Congenital abnormality Results Neonatal Abstinence Syndrome • A diagnosis of NAS was recorded for 236 (40.1%) methadone exposed neonates • NAS was more likely with increasing methadone dose at delivery 0 20 40 60 80 100 Incidence of NAS by Methadone Dose Band at Delivery <=20mg 21-50mg 51-80mg 81-100mg Methadone Dose at Delivery >100mg Incidence of NAS by Methadone Dose Band at Delivery 0 20 40 60 80 100 Excluding Neonates with Positive Urine Toxicology <=20mg 21-50mg 51-80mg 81-100mg Methadone Dose at Delivery >100mg Methadone Dose at Delivery No NAS NAS 150 100 50 0 Mean (SD) Mean (SD) 50.04mg (24.44) 62.51mg (26.29) Independent samples T-Test p<0.001 Limitations • Retrospective study from one centre • Unblinded assessment of NAS • No indication of severity/duration of NAS available • Maternal urine toxicology results not available Implications • Further interventions required to address adverse perinatal outcomes in methadoneexposed pregnancies • Useful information for patient counselling • Robust prospective studies required to confirm dose response effect • Future studies need further objective data on concomitant drug exposures Acknowledgements Thanks to: • Funders – Friends of the Coombe – School of Pharmacy, RCSI • Supervisors • Midwives and other staff who collected the data • Emma McNamee who extracted the data Thank You !