Status:
COMPLETED
Optimizing Pregnancy and Treatment Interventions for Moms 2.0
Lead Sponsor:
University of Utah
Collaborating Sponsors:
University of Pittsburgh
Conditions:
Pregnancy, High Risk
Opioid-Related Disorders
Eligibility:
FEMALE
18+ years
Phase:
NA
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 mo...
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 i...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2022
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT03833245
Start Date
March 11 2019
End Date
October 1 2022
Last Update
February 3 2025
Active Locations (2)
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1
Magee Women's Hospital
Pittsburgh, Pennsylvania, United States, 15213
2
University of Utah
Salt Lake City, Utah, United States, 84108