Perinatal Opioid Use

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04049032
• Other study ID #: Pro00074655
• Status: Completed
• Start date: September 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: August 2019
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use
• Pregnancy

Intervention

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.
• 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..

Locations

Country	Name	City	State
United States	The Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of individuals retained in treatment	Uninterrupted addiction treatment during pregnancy through 6-8 weeks postpartum	6-8 weeks postpartum
Primary	Percent of infants born with Neonatal Abstinence Syndrome (NAS)	Newborn withdrawal, also know as NAS gathered via electronic health record	At Delivery
Secondary	Positive urine drug screens	Number of individuals with a positive urine drug screen	At delivery and 6-8 weeks postpartum
Secondary	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