Optimizing Pregnancy and Treatment Interventions for Moms 2.0
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 4
- 主要终点
- Opioid Use Disorder (OUD) and Other Substance Use Disorder (SUD) Treatment Linkage/Retention
研究概览
简要总结
The US opioid epidemic continues to result in serious health consequences for pregnant and postpartum women. In the US from 2007 to 2012, an average of 21,000 pregnant women each year reported past month opioid misuse. This study aims to provide rapid and targeted primary prevention activities aimed at assisting pregnant women with opioid use disorder (OUD) to become linked to and retained in treatment in order to reduce harms to them (including overdose) and their offspring.
详细描述
Age adjusted rates for overdose among women in the US increased more than six-fold from 1.4 in 1999 to 8.5 in 2016. Examining Pennsylvania (PA) and Utah (UT; the states where recruitment will happen in this study), these states have some of the highest rates of overdose among women compared to other US states. Specifically, PA's overdose rate among women surpassed the national average in 2016, and rates of overdose death in UT among women have ranged 2-9 times higher than the national rate between 2009 to 2016. Both PA and Utah are among the states with the highest opioid prescribing to pregnant women, with Utah being the highest in the nation (41.6%). Prenatal opioid use disorder (OUD) in the US has brought serious health consequences for mother and infant-including preterm delivery, low birth weight, NAS, and poor breastfeeding, and includes substantial expenditures of health care resources. Chances for HIV (OR=20.3, 95% CI = 13.8-29.7) and hepatitis C virus (OR=150.2. 95% CI = 120.9-186.6) infection among women with OUD are markedly higher than for those without OUD. Pregnant women with OUD have high rates of psychiatric illnesses, such as depression and anxiety, and other substance use disorders (SUDs), with particularly high rates of smoking (>80%). Neonatal abstinence syndrome (NAS), an opioid withdrawal syndrome among neonates, has also increased substantially from 3.4/1000 births in 2009 to 5.8/1000 births in 2012. Poly-substance use among pregnant women with OUD has also been associated with higher levels of needed medications to treat NAS and longer duration of NAS treatment. Smoking combined with opioid use during pregnancy has likewise been related to longer duration of NAS treatment, greater NAS severity, and higher levels of medication needed to treat NAS symptomology. Any prenatal opioid use also has been associated with birth defects, including neural tube defects, conoventricular septal defects, atrioventricular septal defects, hypoplastic left heart syndrome, and gastroschisis. Compared with women without any SUDs, children born to mothers with OUD or OUD plus other SUDs also have been documented to have lower cognitive functioning as they mature. Problems resulting from illicit and prescription OUD also result in significant social issues. Pregnant women with OUD have been observed to have financial and housing instability, challenges related to employment, and involvement with the legal system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult (≥18 years)
- •English speaking
- •Pregnant women (pregnancy status verified by gestational age >6 weeks from last menstrual period confirmed by ultrasound)
- •OUD verified by examination of medical records for an OUD diagnosis, urine toxicology, and the Diagnostic and Statistical Manual of Mental Disorders (DSM) Checklist (modified from the DSM-IV to confirm current diagnosis for substance use disorders)
- •Plan to carry their babies to delivery verified by patient self report
- •Participant Exclusion Criteria
- •Experienced a psychotic or a manic episode in the last 30 days documented in their medical record
- •Beyond the 25th week of gestation
- •Cannot provide collateral contact information of 2 persons,
- •Cannot provide a reliable phone number,
- •Plan to move from the area within 2 months of their delivery will or 6 months after not be included in the study
- •Inability or unwillingness of subject or legal guardian/representative to give written informed consent.
- •Other factors that would cause harm or increased risk to the participant or close contacts, or preclude the participant's full adherence with or completion of the study
排除标准
- 未提供
结局指标
主要结局
Opioid Use Disorder (OUD) and Other Substance Use Disorder (SUD) Treatment Linkage/Retention
时间窗: 6 months
Percentage of days of days of attending outpatient and inpatient Substance Use Disorder treatment.
Adherence to Medication-Assisted Treatment (MAT) Medication Use Section
时间窗: 6 months
Adherence to MAT will be assessed through the treatment services review (TSR-6) medication use section defined by percentage days of attendance.
次要结局
- Adequacy of Prenatal Care(1 week)
研究者
Jerry Cochran
Associate Professor
University of Utah
