Fetal assessment before and after dosing with buprenorphine or methadone

Abstract

Aim: To determine pre- and post-dosing effects of prenatal methadone compared to buprenorphine on fetal wellbeing.

Design: A secondary analysis of data derived from the Maternal Opioid Treatment: Human Experimental Research (MOTHER) study, a double-blind, double-dummy, randomized clinical trial.

Setting: Six United States sites and one European site that provided comprehensive opioid-dependence treatment to pregnant women.

Participants: Eighty-one of the 131 opioid-dependent pregnant women completing the MOTHER clinical trial, assessed between 31 and 33 weeks of gestation.

Measurements: Two fetal assessments were conducted, once before and once after study medication dosing. Measures included mean fetal heart rate (FHR), number of FHR accelerations, FHR reactivity in the fetal non-stress test (NST) and biophysical profile (BPP) score.

Findings: Significant group differences were found for number of FHR accelerations, non-reactive NST and BPP scores (all Ps < 0.05). There were no significant group differences before time of dosing. Significant decreases (all Ps < 0.05) occurred from pre- to post-dose assessment for mean FHR, FHR accelerations, reactive NST and fetal movement. The decrease in accelerations and reactive NST were significant only for fetuses in the methadone group, and this resulted in a significantly lower likelihood of a reactive NST compared to fetuses in the buprenorphine group.

Conclusion: Buprenorphine compared with methadone appears to result in less suppression of mean fetal heart rate, fetal heart rate reactivity and the biophysical profile score after medication dosing and these findings provide support for the relative safety of buprenorphine when fetal indices are considered as part of the complete risk-benefit ratio.

Trial registration: ClinicalTrials.gov NCT00271219.

© 2012 The Authors, Addiction © 2012 Society for the Study of Addiction.

Figures

Figure 1

Fetal heart rate estimated marginal means in beats per minute in the pre and post-dose assessments. #Pairwise comparison with a Bonferonni correction, P > 0.05, not significant (ns).

Figure 2

Exponentiated mean number of Fetal Heart Rate (FHR) Accelerations in the pre- and post-dose assessments.

Figure 3

Likelihood estimates for a non-reactive fetal non-stress test in the pre- and post-dose assessments. ** Pairwise comparison with a Bonferonni correction, P < 0.01.

Figure 4

Exponentiated mean Biophysical Profile Score (BPP) in the pre- and post-dose assessments. #Pairwise comparison with a Bonferonni correction, P > 0.05, not significant (ns).