Buprenorphine-naloxone versus buprenorphine for opioid use disorder during pregnancy: A systematic review and meta-analysis.

de Lima, Fernanda Ribeiro; Molino, Gabriela Oliveira Gonçalves; Gallo Ruelas, Mariano; Barbosa, Eduardo Cerchi; Silva, Pedro Henrique Costa Matos da; Guimarães, Felipe Bandeira de Melo; Petrucci, Arthur Bezerra Cavalcanti; Silva, Giovanna Hanike Santos da et al. · Drug Alcohol Depend · 2025

meta_analysis · Level I

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Abstract

The standard of care for treating opioid use disorder (OUD) during pregnancy includes either buprenorphine or methadone. Although buprenorphine-naloxone presents an alternative due to the reduced risk of misuse , evidence regarding its impact on pregnancy and infant health remains limited. This systematic review and meta-analysis aims to compare buprenorphine-naloxone vs buprenorphine alone for OUD during pregnancy, assessing gestational and neonatal outcomes. We systematically searched MEDLINE, Embase, and Cochrane Library databases to identify studies comparing buprenorphine-naloxone versus buprenorphine for OUD during pregnancy. The primary outcome assessed was neonatal abstinence syndrome (NAS). Pooled risk ratios (RR) and mean differences (MD) with 95 % confidence intervals (CI) were calculated using R statistical software and quality assessment was performed following Cochrane recommendations. Six retrospective cohorts were included, encompassing 9348 mother-infant dyads, of whom 38.3 % received buprenorphine-naloxone. NAS requiring treatment (RR 0.77; 95 % CI 0.71-0.84; p < 0.01) and small for gestational age infants (RR 0.86; 95 % CI 0.76-0.98; p = 0.03) were significantly less frequent in the buprenorphine-naloxone group. No significant differences were found between the groups for cesarean delivery (RR 1.04; 95 % CI 0.98-1.11; p = 0.20), low birth weight (RR 1.07; 95 % CI 0.91-1.24; p = 0.41), and preterm delivery (RR 1.07; 95 % CI 0.96-1.21; p = 0.22). Pregnant people treated with buprenorphine-naloxone had neonates with a lower risk of small for gestational age and NAS. Further research is needed to confirm these findings and explore other pregnancy-related and neonatal outcomes.

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