Opioid UseNCT04049032
Perinatal Opioid Use
An observational study of Opioid Use and Pregnancy, run by Medical University of South Carolina at 1 site in United States.
Trial summary
To compare maternal and newborn outcomes among pregnant women with OUD receiving care via telemedicine versus in-person. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Opioid Use, Pregnancy
- What is being tested?
- In-Person Perinatal OUD Treatment and Perinatal OUD Treatment via Telemedicine
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2017to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- Not currently pregnant or receiving perinatal care
- Not in agreement with Patient-Physician Agreement
Trial locations and contacts
1 site in 1 country.
United States1 site
The Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: 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.
Read the 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.
- Conditions
- Opioid Use, Pregnancy
- Being tested
- In-Person Perinatal OUD Treatment, Perinatal OUD Treatment via Telemedicine
- Keywords
- pregnancy, prescription opioids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-Person Perinatal OUD TreatmentBehavioural
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 TelemedicineBehavioural
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..
| Study group | Role | What they receive |
|---|---|---|
| In-Person Participants | This group received perinatal OUD treatment in-person. Receives: Behavioral: In-Person Perinatal OUD Treatment | |
| Telemedicine Participants | This group received perinatal OUD treatment via telemedicine. Receives: Behavioral: Perinatal OUD Treatment via Telemedicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of individuals retained in treatment
Uninterrupted addiction treatment during pregnancy through 6-8 weeks postpartum
Measured: 6-8 weeks postpartum
Percent of infants born with Neonatal Abstinence Syndrome (NAS)
Newborn withdrawal, also know as NAS gathered via electronic health record
Measured: At Delivery
Secondary outcomes (2)
Positive urine drug screens
Number of individuals with a positive urine drug screen
Measured: 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
Measured: Assessed up to 6 months following delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start1 Sep 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04049032
- Sponsor's protocol ID
- Pro00074655
- Status last verified
- Sep 2024
- First submitted
- 1 Aug 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32003816
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MUSC Women's Reproductive Behavioral Health Program for Opioid Use During Pregnancy
- ClinicalTrials.gov ID
- NCT04049032
- Acronym / sponsor ID
- Pro00074655
- Conditions
- Opioid Use, Pregnancy
- Keywords
- pregnancy, prescription opioids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 7 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In-Person Participants | – | Behavioral: In-Person Perinatal OUD TreatmentThis group received perinatal OUD treatment in-person. |
| Telemedicine Participants | – | Behavioral: Perinatal OUD Treatment via TelemedicineThis group received perinatal OUD treatment via telemedicine. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Not currently pregnant or receiving perinatal care
- Not in agreement with Patient-Physician Agreement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-Person Perinatal OUD TreatmentParticipants 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. | Behavioural | In-Person Participants |
| Perinatal OUD Treatment via TelemedicineParticipants 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.. | Behavioural | Telemedicine Participants |
Primary outcome
Number of individuals retained in treatment
Time frame: 6-8 weeks postpartum
Uninterrupted addiction treatment during pregnancy through 6-8 weeks postpartum
Percent of infants born with Neonatal Abstinence Syndrome (NAS)
Time frame: At Delivery
Newborn withdrawal, also know as NAS gathered via electronic health record
2 secondary outcomes
Positive urine drug screens
Time frame: At delivery and 6-8 weeks postpartum
Length of newborn hospital stay and birth weight
Time frame: Assessed up to 6 months following delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 32003816Guille 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.
- Individual participant dataSharing planned: No
Related trials for Opioid Use
RecruitingPhase 2
Infusion of Lidocaine and Steroids in Middle Meningeal Artery for Pain in Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Aneurysmal, Headache
Active, not recruiting
Pain Self-Management and Treatment Engagement for Patients Taking Opioids
Chronic Pain, Opioid Use Disorder
Recruiting
Peer Support Workers Study
Substance Use Disorder (SUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Recruiting
Using Facebook to Support Opioid Recovery Among American Indian Women
Opioid Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Use and Pregnancy, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of individuals retained in treatment (time frame: 6-8 weeks postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04049032, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.