This retrospective cohort compared 108 pregnancies exposed to buprenorphine alone with 85 exposed to buprenorphine–naloxone. Neonatal abstinence syndrome requiring treatment was observed in 54.6% and 35.3% of infants, respectively. Although the unadjusted difference favored the combination product, it was not statistically significant after adjustment for clinical and treatment differences; secondary outcomes were similar. The authors considered buprenorphine–naloxone an acceptable treatment option in this cohort, but the observational design cannot establish comparative causality.
Abstract
Objective:
To compare maternal and fetal outcomes among dyads prescribed buprenorphine and naloxone or buprenorphine during pregnancy.
Methods:
Retrospective cohort study of patients with opioid use disorder obtaining care in a comprehensive, perinatal program. Patients utilized medication for opioid use disorder: a buprenorphine and naloxone combination product or buprenorphine monotherapy. The primary outcome was neonatal abstinence syndrome requiring treatment. Maternal secondary outcomes included: negative urine drug screen at delivery, obstetrical care attendance, primary cesarean delivery, and preterm delivery. Neonatal secondary outcomes included neonatal biometry, admission to neonatal intensive care, appropriate findings on cord toxicology, and length of stay. Univariate analyses included Chi square, Fisher exact, t-, or Mann-Whitney tests, as appropriate. Multivariate binary logistic regressions examined the association of type of buprenorphine product with diagnosis of neonatal abstinence syndrome requiring treatment and adjusted for variables significantly different in between-group comparisons and correlates of treatments and the primary outcome.
Results:
The rate of neonatal abstinence syndrome was significantly higher (P = 0.007) among infants exposed in utero to buprenorphine versus buprenorphine and naloxone: 59/108 (54.6%) versus 30/85 (35.3%), respectively. The combined product, relative to the monoproduct, was associated with lower odds of neonatal abstinence syndrome: odds ratio (OR) = 0.453 (95% confidence interval [CI] 0.253-0.813; P = 0.008). Adjusting for dose of buprenorphine product at delivery, year of expected delivery, type of prescriber, diagnosis of hepatitis C, and preterm delivery negated these results: adjusted OR = 0.627 (95% CI 0.309-1.275). Secondary outcomes were similar.
Conclusion:
Compared with buprenorphine monotherapy, the combined buprenorphine and naloxone product was an acceptable alternative pharmacologic treatment for opioid use disorder during pregnancy.
