Predicting and Preventing Adverse Maternal and Child Outcomes of Opioid Use Disorder in Pregnancy

Recruiting

• Conditions: Pregnancy Related; Opioid Use Disorder
• Interventions: Drug: Buprenorphine/ Methadone exposure

• Registration Number: NCT05942313
• Lead Sponsor: Ilana Hull

Brief Summary

This study will be a 12-month prospective, genotype-blinded longitudinal observational study with current standard of clinical care. This study will enroll 100 pregnant women with OUD at UPMC Hospitals with its high volumes. Because of the observational nature of the study, the anticipated dropout rate will be ≤ 20%. Investigators expect the effective sample size of evaluable patients will be 200 with longitudinal data.

Detailed Description

Background: 7% of pregnant women in the U.S. use opioids and 21% of these women report misuse, making opioid use disorder (OUD) a major public health concern during pregnancy. The number of infants born with prenatal opioid exposure, neonatal opioid withdrawal syndrome (NOWS) and costly prolonged hospitalization has increased exponentially. The opioid epidemic is further worsened by the ongoing COVID-19 pandemic. Despite medication treatment for OUD with buprenorphine (BUP) or methadone (METH), these pregnant women continue to be at high risk for early relapse, polysubstance use, and depression. These infants are at risk for not only immediate NOWS and also poor long-term neurodevelopmental and behavioral outcomes. Genetic factors influence 30-60% of opioid adverse events (AEs). In pregnant women on medication management for OUD, and infants receiving opioids for NOWS treatment there is variability in dose required to prevent withdrawal symptoms and craving, likely related to physiological alterations, upregulation of metabolic and biological pathways, determined in part by opioid pharmacogenomics. Investigators have shown that in children and adults, opioid related poor clinical outcomes are related to opioid receptor genetic variations and resulting variations in their metabolism. Maternal depression and anxiety increase the risks for OUD, maternal relapse, NOWS and negatively impact pregnant women and their children. Thus, there is an urgent and unmet clinical need for a reliable tool to proactively predict maternal relapse, NOWS, and improve the safety of pregnant women with OUD and their children.

Study Timeline

• Study First Submitted: 2023-07-03
• Study First Submitted QC: 2023-07-03
• Study First Posted: 2023-07-12
• Study Start: 2023-08-28
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Pregnant women with OUD and their infant
• Currently on BUP/METH for OUD
• Enrolled in prenatal opioid maintenance program
• Age >18 years
• Singleton pregnancy
• Planned delivery at UPMC's Magee Womans Hospital
• Positive opioid urine screen results

Exclusion Criteria

• Serious maternal medical illness as deemed by the PI that would make it challenging to comply with study procedures
• HIV or AIDS
• Known major fetal congenital abnormalities

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant women with Opioid Use Disorder (OUD)	Buprenorphine/ Methadone exposure	This study will enroll 100 pregnant women with OUD at UPMC with its high volumes

Primary Outcome Measures

Name	Time	Method
Incidence of maternal opioid relapse	Measured from enrollment to 3-months post delivery	Measured via binary response, yes/no
Incidence of NOWS	Measured at delivery	Clinical definition of NOWS: Substance withdrawal encompasses a continuum of variable clinical expression from neonate to neonate; the diagnosis is not limited only to neonates who require pharmacotherapy. Incidence of NOWS measured by binary response, yes/no

Secondary Outcome Measures

Name	Time	Method
Severity of Maternal Opioid Relapse	Measured from enrollment to 3-months post delivery	Severity of maternal opioid relapse measured by requirement of medical treatment (binary response, yes/no)
Severity of NOWs	Measured at delivery	Severity of NOWs measured by the need for \>3 days of hospital stay (binary response, yes/no)

Trial Locations

Locations (1)

UPMC Magee-Womens Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States