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

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Related; Opioid Use Disorder
• Intervention / Treatment: Drug: Buprenorphine/ Methadone exposure

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Amy Monroe, MPH, MBA; Phone Number: 412-623-6382; Email: monroeal@upmc.edu
• Study Contact Backup: Name: Carly Riedmann, MPH; Phone Number: 412-623-4147; Email: riedmannca@upmc.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • UPMC Magee-Womens Hospital
      • Contact: Carly Riedmann, MPH; Phone Number: 412-623-4147; Email: riedmannca@upmc.edu
      • Contact: Ilana Hull, MD; Email: hulli@upmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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 with its high volumes. Because of the observational nature of the study, the anticipated dropout rate will be ≤ 20%. We expect the effective sample size of evaluable patients will be 200 with longitudinal data.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pregnant women with Opioid Use Disorder (OUD); This study will enroll 100 pregnant women with OUD at UPMC with its high volumes	Drug: Buprenorphine/ Methadone exposure; Validate candidate genes- and prenatal opioid exposure- related maternal relapse and NOWS outcome associations in pregnant women and their newborns.; Other Names: Opioid Use Disorder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of maternal opioid relapse	Measured via binary response, yes/no	Measured from enrollment to 3-months post delivery
Incidence of NOWS	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	Measured at delivery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ilana Hull
• Collaborators: National Institute on Drug Abuse (NIDA); OpalGenix, Inc
• Investigators: Principal Investigator: Ilana Hull, MD, Univrsity of Pittsburgh / UPMC Magee Womens Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: July 3, 2023
• First Submitted That Met QC Criteria: July 3, 2023
• First Posted (Actual): July 12, 2023

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Alkaloids; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Morphinans; Opiate Alkaloids; Heterocyclic Compounds, Bridged-Ring; Phenanthrenes; Buprenorphine
• Other Study ID Numbers: STUDY23010043; 1R43DA058430-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We intend to share data that is generated from the grant at the earliest opportunities throughout this research project in counsel with our intellectual property lawyers. The details of the risk prediction algorithms will remain proprietary and will be protected as a trade secret.
• IPD Sharing Time Frame: Data will become available after completion of the two-year enrollment period.
• IPD Sharing Access Criteria: This information will be held in a commercial cloud-based data portal with a password and encrypted security, such as commercial sources BOX, Dropbox, Engnyte, and Sharepoint. Access to the electronic portal will only be provided after the receiving party has signed a confidentiality agreement. The data will not be downloadable but rather only allow for viewing from the cloud-supported site. This is the process used during corporate due diligence in determining the potential to invest and is an industry-accepted approach. This approach will be used for potential investors and additional collaborators on future projects.
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No