Impact of Collaborative Care for Pregnant Women With Opioid Use Disorder in Low-Resource Obstetric Settings

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 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Study population: A core team of clinical providers at each obstetric site (i.e., nurse case manager, peer navigator, advanced practice provider, behavioral health provider, and lead obstetrician/gynecologist) have already committed to providing clinical care for the adapted CCM and participate in all stages of the research process. As such, they will not need to be recruited for participation. Maternal and child outcome data will be collected retrospectively from the EHR and individual patients will not be recruited to participate in the study. A small subset of pregnant women (n=50) who meet DSM-V criteria for OUD and who receive care at obstetric sites will be recruited for a one-time, semi-structured qualitative interview.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Conditions

Pregnancy, Postpartum Period, Opioid Use Disorder

Being tested

Usual Care, Adapted Collaborative Care Model (CCM)

Keywords

HEAL Inititative, HEAL, MOUD, OUD, Pregnancy, Postpartum, Substance

Medical subject headings

Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Usual CareBehavioural

  Usual, referral-based, care.

• Adapted Collaborative Care Model (CCM)Behavioural

  Person-centered, recovery supports.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Patient Initiation of Medication for Opioid Use Disorder (MOUD)

   Patient Initiation of Medication for Opioid Use Disorder (MOUD) as measured by total buprenorphine or methadone initiation in Electronic Health Record (EHR) and Medicaid claims data

   Measured: During pregnancy (up to 40 weeks), up to 1 year post delivery

2. Patient Duration of MOUD

   Patient Duration of MOUD as measured by proportion of days' covered incorporating buprenorphine or methadone treatment in EHR and claims data

   Measured: During pregnancy (up to 40 weeks), up to 1 year post delivery

3. Patient Overdose

   Patient Overdose as measured by total count of nonfatal or fatal overdose events in EHR and claims data

   Measured: During pregnancy (up to 40 weeks), up to 1 year post delivery

4. Patient child foster care placement

   Patient child foster care placement as measured by total child placements in foster care system according to child protective service data linked with Medicaid data

   Measured: Delivery through 1 year postpartum

5. Patient utilization of well-child services

   Patient utilization of well-child services as measured by total well-child visits in EHR and claims data

   Measured: Delivery through 1 year postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted4 May 2025
2. Study start24 Jun 2025
3. Primary completionAug 2030 (estimated)
4. Study completionAug 2031 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for PregnancyStudies of the same condition, open and under way.
• More trials run by University of PittsburghThe 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.