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Perinatal Opioid Use

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04049032
Enrollment
98
Registered
2019-08-07
Start date
2017-09-01
Completion date
2018-12-31
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Use, Pregnancy

Keywords

pregnancy, prescription opioids

Brief summary

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

Detailed description

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.

Interventions

BEHAVIORALIn-Person Perinatal OUD Treatment

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.

BEHAVIORALPerinatal OUD Treatment via Telemedicine

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..

Sponsors

Medical University of South Carolina
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of individuals retained in treatment6-8 weeks postpartumUninterrupted addiction treatment during pregnancy through 6-8 weeks postpartum
Percent of infants born with Neonatal Abstinence Syndrome (NAS)At DeliveryNewborn withdrawal, also know as NAS gathered via electronic health record

Secondary

MeasureTime frameDescription
Positive urine drug screensAt delivery and 6-8 weeks postpartumNumber of individuals with a positive urine drug screen
Length of newborn hospital stay and birth weightAssessed up to 6 months following deliveryAverage number of days infant was in the hospital following delivery; weight of infant at birth

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026