Perinatal Opioid Use

NCT ID: NCT04049032

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

98 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-01

Study Completion Date

2018-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Opioid Use Pregnancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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In-Person Participants

This group received perinatal OUD treatment in-person.

In-Person Perinatal OUD Treatment

Intervention Type 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.

Telemedicine Participants

This group received perinatal OUD treatment via telemedicine.

Perinatal OUD Treatment via Telemedicine

Intervention Type 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..

Interventions

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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.

Intervention Type 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..

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 32003816 (View on PubMed)

Other Identifiers

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Pro00074655

Identifier Type: -

Identifier Source: org_study_id

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