This study will compare medically-supervised withdrawal (MSW, 'detoxification') to opioid agonist treatment (OAT, 'maintenance') with buprenorphine for pregnant women with opioid use disorder in terms of maternal, fetal, and neonatal outcomes. Outcomes will be assessed during pregnancy, at birth and for 12 months postpartum. This study has the potential to impact health service policy and practices in terms of the treatment options of pregnant women with opioid use disorder.
Some inclusion/exclusion criteria are purposely omitted at this time to preserve scientific integrity. They will be included after the trial is complete.
Study Type
OBSERVATIONAL
Enrollment
88
6-8 day withdrawal with buprenorphine/naloxone
Induction and maintenance with buprenorphine/naloxone
Obstetrical visits, counseling, case management, psychiatry services, and urine drug screening
Mountain Area Health Education Center
Asheville, North Carolina, United States
UNC Chapel Hill Horizons
Chapel Hill, North Carolina, United States
University of Vermont
Burlington, Vermont, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Proportion of mothers who discontinued 1st treatment choice prior to delivery
Time frame: Antepartum period
Proportion of mothers engaged in treatment at delivery
Behavior health treatment or medical treatment in past 21 days
Time frame: Antepartum period
Proportion of mothers with illicit substance use at delivery
Positive vs. negative for any illicit substance in the urine
Time frame: At delivery
Proportion of mother-child dyads with delivery complications
Yes vs. no code for the presence or absence of delivery complications such as uterine rupture, placental abruption, low birth weight, chorioamnionitis, and meconium staining
Time frame: At delivery
Proportion of neonates receiving medication treatment for neonatal abstinence syndrome (NAS)
Yes vs. no
Time frame: At hospital discharge, an average of 10 days after delivery
Total average amount of medication given to treat NAS
Morphine Equivalent Dose in mg
Time frame: At hospital discharge, an average of 10 days after delivery
Total average length of neonatal hospital stay
Days
Time frame: At hospital discharge, an average of 10 days after delivery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.