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OpenTrials
Completed

NCT Number: NCT04049032

Perinatal Opioid Use

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

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Key information

Conditions

Opioid Use Pregnancy

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

The Medical University of South Carolina

Charleston, South Carolina, 29425, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

In-Person Perinatal OUD Treatment

Behavioral

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.

Perinatal OUD Treatment via Telemedicine

Behavioral

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..

Primary outcomes

  1. Number of individuals retained in treatment

    Time frame: 6-8 weeks postpartum

    Uninterrupted addiction treatment during pregnancy through 6-8 weeks postpartum

  2. Percent of infants born with Neonatal Abstinence Syndrome (NAS)

    Time frame: At Delivery

    Newborn withdrawal, also know as NAS gathered via electronic health record

Secondary outcomes

  1. Positive urine drug screens

    Time frame: At delivery and 6-8 weeks postpartum

    Number of individuals with a positive urine drug screen

  2. Length of newborn hospital stay and birth weight

    Time frame: Assessed up to 6 months following delivery

    Average number of days infant was in the hospital following delivery; weight of infant at birth

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 7, 2019
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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