Pregnancy Related Clinical Trial
Official title:
Optimizing Pregnancy and Treatment Interventions for Moms 2.0
NCT number | NCT03833245 |
Other study ID # | 116398 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 11, 2019 |
Est. completion date | October 1, 2022 |
Verified date | November 2022 |
Source | University of Utah |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 106 |
Est. completion date | October 1, 2022 |
Est. primary completion date | October 1, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Magee Women's Hospital | Pittsburgh | Pennsylvania |
United States | University of Utah | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
University of Utah | University of Pittsburgh |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Opioid Use Disorder (OUD) and other Substance Use Disorder (SUD) Treatment Linkage/Retention | OUD and other SUD treatment linkage/retention will be assessed through the treatment services review (TSR-6). The TSR-6 is a clinically validated 56-item measure with excellent reliability. We will capture frequency of meetings, sessions, day in OUD and other substance counseling. | 36 months | |
Primary | Opioid Abstinence | Opioid abstinence will be accessed using a 14-panel urine toxicology screening. | 36 months | |
Primary | Adherence to Medication-Assisted Treatment (MAT) | Adherence to MAT will be accessed using a 14-panel urine toxicology screening. | 36 months | |
Primary | Adherence to Medication-Assisted Treatment (MAT) | Adherence to MAT will be assessed through the treatment services review (TSR-6) medication use section. | 36 months | |
Primary | Linkage/Retention in Psychosocial Services | Linkage/retention in psychosocial services will be accessed through medical record review. | 36 months | |
Secondary | Adequacy of Prenatal Care | Capturing prenatal care will be accessed through the adequacy of prenatal care utilization index (APNCU). This index will be used to determine the sufficiency of prenatal care participants received. | 36 months | |
Secondary | Needle use and safe sex frequency | The Risk Behavior Survey (RBA) will be used to access HIV/Hepatitis C virus (HCV) risk behaviors. The RBA is a self-report, 22-item assessment provides the highest 30-day reliability among standardized instruments for HIV/HCV-risk behaviors among drug users. | 36 months | |
Secondary | Incidence of depression and anxiety | The patient health questionnaire (PHQ) will be used to assess mental health. The PHQ is an 11-item mental health assessment with demonstrated criterion validity and reliability. The PHQ accesses depression, suicide ideation, anxiety, somatoform, eating and alcohol use disorders. | 36 months | |
Secondary | Child and mother bond following delivery | Child and mother indicators will be accessed through the Maternal-Fetal Attachment survey. | 36 months |
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