Perinatal Opioid Use

Completed

• Conditions: Opioid Use; Pregnancy
• Interventions: Behavioral: Perinatal OUD Treatment via Telemedicine; Behavioral: In-Person Perinatal OUD Treatment

• Registration Number: NCT04049032
• Lead Sponsor: Medical University of South Carolina

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.

Study Timeline

• Study Start: 2017-09-01
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-08
• Study First Submitted: 2019-08-01
• Study First Submitted QC: 2019-08-06
• Last Update Submitted: 2019-08-06
• Study First Posted: 2019-08-07
• Last Update Posted: 2019-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 98

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Telemedicine Participants	Perinatal OUD Treatment via Telemedicine	This group received perinatal OUD treatment via telemedicine.
In-Person Participants	In-Person Perinatal OUD Treatment	This group received perinatal OUD treatment in-person.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States