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Идёт набор NCT05942313

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

Наблюдательное Opioid Use Disorder Pregnancy Related

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Buprenorphine/ Methadone exposure.
Кому может быть актуально
Состояния в реестре: Opioid Use Disorder, Pregnancy Related. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

  • Incidence of maternal opioid relapse [Срок оценки: Measured from enrollment to 3-months post delivery]
  • Incidence of NOWS [Срок оценки: Measured at delivery]
Вторичные конечные точки (2)
  • Severity of Maternal Opioid Relapse [Срок оценки: Measured from enrollment to 3-months post delivery]
  • Severity of NOWs [Срок оценки: Measured at delivery]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • UPMC Magee-Womens Hospital — Pittsburgh

Идентификаторы

NCT: NCT05942313 · STUDY23010043 · 1R43DA058430-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗