Perinatal Opioid Use

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

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

Study Overview

• Status: Completed
• Conditions: Pregnancy; Opioid Use
• Intervention / Treatment: Behavioral: In-Person Perinatal OUD Treatment; Behavioral: Perinatal OUD Treatment via Telemedicine

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 Type: Observational
• Enrollment (Actual): 98

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • The Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

A cohort derived from a prospectively collected database including 94 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
In-Person Participants; This group received perinatal OUD treatment in-person.	Behavioral: In-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.
Telemedicine Participants; This group received perinatal OUD treatment via telemedicine.	Behavioral: Perinatal 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..

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medical University of South Carolina

Publications and helpful links

General Publications

• Guille C, Simpson AN, Douglas E, Boyars L, Cristaldi K, McElligott J, Johnson D, Brady K. Treatment of Opioid Use Disorder in Pregnant Women via Telemedicine: A Nonrandomized Controlled Trial. JAMA Netw Open. 2020 Jan 3;3(1):e1920177. doi: 10.1001/jamanetworkopen.2019.20177.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: August 1, 2019
• First Submitted That Met QC Criteria: August 6, 2019
• First Posted (Actual): August 7, 2019

Study Record Updates

• Last Update Posted (Actual): August 7, 2019
• Last Update Submitted That Met QC Criteria: August 6, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: pregnancy; prescription opioids
• Other Study ID Numbers: Pro00074655

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No