Optimizing Pregnancy and Treatment Interventions for Moms 2.0

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.

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