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

NCT ID: NCT05942313

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-28
• Study Completion Date: 2025-12-01

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.

Conditions

Opioid Use Disorder; Pregnancy Related

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Pregnant women with Opioid Use Disorder (OUD)

This study will enroll 100 pregnant women with OUD at UPMC with its high volumes

Buprenorphine/ Methadone exposure

Intervention Type: DRUG

Validate candidate genes- and prenatal opioid exposure- related maternal relapse and NOWS outcome associations in pregnant women and their newborns.

Interventions

Buprenorphine/ Methadone exposure

Validate candidate genes- and prenatal opioid exposure- related maternal relapse and NOWS outcome associations in pregnant women and their newborns.

Intervention Type: DRUG

Other Intervention Names

Opioid Use Disorder

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

OpalGenix, Inc

INDUSTRY

Sponsor Role: collaborator

Ilana Hull

OTHER

Sponsor Role: lead

Responsible Party

Ilana Hull

Assistant Professor of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ilana Hull, MD

Role: PRINCIPAL_INVESTIGATOR

Univrsity of Pittsburgh / UPMC Magee Womens Hospital

Locations

UPMC Magee-Womens Hospital

Pittsburgh, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Amy Monroe, MPH, MBA

Role: CONTACT

monroeal@upmc.edu

412-623-6382

Carly Riedmann, MPH

Role: CONTACT

riedmannca@upmc.edu

412-623-4147

Facility Contacts

Ilana Hull, MD

Role: primary

hulli@upmc.edu

Carly Riedmann, MPH

Role: backup

riedmannca@upmc.edu

412-623-4147

Other Identifiers

1R43DA058430-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY23010043

Identifier Type: -

Identifier Source: org_study_id