Clinical trial NCT03833245: Optimizing Pregnancy and Treatment Interventions for Moms 2.0
Official title: Optimizing Pregnancy and Treatment Interventions for Moms 2.0
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy, High Risk
Opioid-Related Disorders
Pregnancy Related
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh
First posted: 2019-02-06
Enrollment: 102
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Primary outcomes:
measure: Opioid Use Disorder (OUD) and Other Substance Use Disorder (SUD) Treatment Linkage/Retention
timeFrame: 6 months
measure: Adherence to Medication-Assisted Treatment (MAT) Medication Use Section
timeFrame: 6 months
Secondary outcomes:
measure: Adequacy of Prenatal Care
timeFrame: 1 week
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Magee Women's Hospital
state: Pennsylvania
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Gerald Cochran, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bryan MA, Mallik D, Cochran G, Lundahl B. Mindfulness and Savoring: A Commentary on Savoring Strategies and Their Implications for Addiction Treatment. Subst Use Misuse. 2022;57(5):822-826. doi: 10.1080/10826084.2022.2046090. Epub 2022 Mar 10.
citation: Cochran G, Smid MC, Krans EE, Bryan MA, Gordon AJ, Lundahl B, Silipigni J, Haaland B, Tarter R. A pilot multisite study of patient navigation for pregnant women with opioid use disorder. Contemp Clin Trials. 2019 Dec;87:105888. doi: 10.1016/j.cct.2019.105888. Epub 2019 Nov 12.