Hormones and Infant Caregiving in Postpartum Opioid Use Disorder Recovery: Compliance and Satisfaction with a Prospective Cohort Study Protocol Designed to Identify Novel Support Targets

BackgroundAlthough treatment for opioid use disorder (OUD) often yields high adherence during pregnancy, the risk of returning to opioid misuse during postpartum is high. There are currently no relapse prevention programs tailored to this unique time period. ObjectivesUsing a prospective cohort study, we seek to identify hormones and/or infant caregiving approaches as predictors of postpartum opioid misuse. As a first step in dissemination of results, this report contains a detailed account of the protocol, as well as recruitment, retention, compliance, and participant satisfaction. PopulationParticipants were individuals with OUD (OUD+) and those without (OUD-) who were followed from late pregnancy ([≥]gestational week 36) to postpartum month five. MethodsFrom childbirth to postpartum week 12, participants completed daily surveys (capturing use, craving, interactions with infant) and weekly face-to-face visits (including collection of biological samples for hormone assays). Follow-up visits using the same procedures occurred at postpartum month four and five. Preliminary ResultsA total of 50 OUD+ and 21 OUD- participants enrolled, 93% notified the study staff of childbirth, 87% completed at least one postpartum clinic visit, and 73% completed through postpartum month five. Compliance with procedures ranged from 66% for saliva samples and daily surveys to 78% for weekly surveys, generally with lower compliance among OUD+ and at later study time points. Participants, regardless of group and time point, reported high study satisfaction (e.g., on a scale where 0 is "not at all" and 3 is "extremely", on average participants reported 2.9{+/-}0.4 for their willingness to complete this study again). ConclusionsThis prospective cohort study was well tolerated despite the challenging postpartum period. Data collected will provide ample opportunities to identify novel risk/protective factors to inform the development of new relapse prevention intervention programs specific to the needs of those with OUD during early postpartum. SynopsisUsing a novel protocol with daily surveys plus weekly face-to-face visits with biological sample collection from late pregnancy through 12 weeks postpartum, we report on the compliance with data collection methodologies over time between those with and without opioid use disorder. We observed fairly high levels of retention (e.g., 75% completed through postpartum week 12) and compliance (e.g., 69% of weekly dried blood spots were collected) with very high satisfaction (e.g., on a scale where 0 is "not at all" and 3 is "extremely", on average, participants reported 2.9{+/-}0.4 for their willingness to participate again). These observations suggest that both those with and without opioid use disorder are willing and able to participate in an intensive, multi-method, prospective study during the early postpartum period.