Perinatal Opioid Use

Study Overview
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Brief Summary
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To compare maternal and newborn outcomes among pregnant women with OUD receiving care via telemedicine versus in-person.

Detailed Description
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Participants: Pregnant women with OUD. Intervention: Participants were seen weekly for four weeks, every two weeks for four weeks and monthly thereafter and provided relapse-prevention therapy and buprenorphine. Design: A cohort derived from a prospectively collected database including 98 women receiving perinatal OUD treatment in an obstetric practice by telemedicine or in-person and followed until 6-8 weeks postpartum from September, 2017 to December, 2018. Logistic regression with propensity score adjustment was applied to reduce group selection bias and control for potentially confounding variables. Setting: Four outpatient obstetric practices in the southeast.

Official Title
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MUSC Women's Reproductive Behavioral Health Program for Opioid Use During Pregnancy

Conditions
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Opioid Use, Pregnancy

Intervention / Treatment
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* Behavioral: In-Person Perinatal OUD Treatment
* Behavioral: Perinatal OUD Treatment via Telemedicine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult females, any race or ethnicity, age 18-45 years Currently pregnant Opioid Use Disorder (OUD) received in person or telemedicine treatment for OUD in their obstetrician's office Exclusion Criteria: Not currently pregnant or receiving perinatal care Not in agreement with Patient-Physician Agreement

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| In-Person Participants<br>This group received perinatal OUD treatment in-person. | Behavioral: In-Person Perinatal OUD Treatment<br>* Participants were seen weekly for four weeks, every two weeks for four weeks and monthly thereafter and provided relapse-prevention therapy and buprenorphine as part of standard of care.<br>|
| Telemedicine Participants<br>This group received perinatal OUD treatment via telemedicine. | Behavioral: Perinatal OUD Treatment via Telemedicine<br>* Participants were seen weekly for four weeks, every two weeks for four weeks and monthly thereafter and provided relapse-prevention therapy and buprenorphine as part of standard of care..<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of individuals retained in treatment | Uninterrupted addiction treatment during pregnancy through 6-8 weeks postpartum | 6-8 weeks postpartum | 
| Percent of infants born with Neonatal Abstinence Syndrome (NAS) | Newborn withdrawal, also know as NAS gathered via electronic health record | At Delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive urine drug screens | Number of individuals with a positive urine drug screen | At delivery and 6-8 weeks postpartum | 
| Length of newborn hospital stay and birth weight | Average number of days infant was in the hospital following delivery; weight of infant at birth | Assessed up to 6 months following delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pregnancy, prescription opioids