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NCT Number: NCT05942313

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.

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Key information

Conditions

Opioid Use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Pregnancy Related Substance-Related Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Buprenorphine/ Methadone exposure

Drug

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

Primary outcomes

  1. Incidence of maternal opioid relapse

    Time frame: Measured from enrollment to 3-months post delivery

    Measured via binary response, yes/no

  2. Incidence of NOWS

    Time frame: 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 outcomes

  1. Severity of Maternal Opioid Relapse

    Time frame: Measured from enrollment to 3-months post delivery

    Severity of maternal opioid relapse measured by requirement of medical treatment (binary response, yes/no)

  2. Severity of NOWs

    Time frame: Measured at delivery

    Severity of NOWs measured by the need for >3 days of hospital stay (binary response, yes/no)

Study contacts

Contact information is provided by the study sponsor or research team.

Amy Monroe, MPH, MBA

CONTACT

[email protected]

412-623-6382

Carly Riedmann, MPH

CONTACT

[email protected]

412-623-4147

Sponsors and collaborators

Lead sponsor

Ilana Hull

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • OpalGenix, Inc

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 12, 2023
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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