Treatment of Pregnant Women With OUD

Completed · Not applicable

Conditions studied: Opioid-use Disorder

In brief

The investigators are testing two models of support for pregnant women with an opioid use disorder (OUD)

Key facts

Study ID

NCT04240392

Run by

Yale University

People needed

230

Starts

2020-06-18

Expected to finish

2024-10-10

Last updated by the study team

2025-05-21

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Provision of signed and dated informed consent form
• Females age 18 or older
• Documented pregnancy in the medical record at less than 34 weeks gestation
• Delivery date no later than July 1, 2024
• Willingness to adhere to the study schedule
• Confirmed opioid use disorder by the DSM-5 Opioid Use Disorder questionnaire
• Ability to communicate in English
• No current plan to move out of the obstetrical provider treatment area within the study timeframe of approximately 44 weeks

You may not qualify if…

• Experiencing cognitive or emotional impairment that precludes the participant from providing informed consent
• Current hospitalization, incarceration, or institutionalization (if women present for care after institutionalization, participation is possible
• Current court case pending that would make incarceration likely during the study treatment period (approximately 44 weeks)

Where it is running

• Hartford Hospital — Hartford, Connecticut, United States
• Hospital of Central CT — New Britain, Connecticut, United States
• Yale New Haven Hospital Maternal Fetal Medicine Unit — New Haven, Connecticut, United States
• Yale New Haven Hospital Women's Center/Hill Health Center — New Haven, Connecticut, United States
• Coastal ObGyn & Midwifery — New London, Connecticut, United States
• OB Gyn Services PC — Norwich, Connecticut, United States
• Essex County ObGyn — Beverly, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• AFA Obstetrics & Gynecology — Concord, Massachusetts, United States
• Women's Health, Lowell General Hospital — Lowell, Massachusetts, United States
• Wesson's Women's Clinic UMASS Baystate — Springfield, Massachusetts, United States

Full record on ClinicalTrials.gov

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