Project Summary
PCORI has identified treatment for opioid use disorder among pregnant women, with a focus on maternal and neonatal outcomes, as an important research topic. To compare the effectiveness of different treatment approaches, PCORI launched an initiative in 2017 on Medication-Assisted Treatment (MAT) Delivery for Pregnant Women with Substance Use Disorders Involving Prescription Opioids and/or Heroin. The initiative funded this research project.
COVID-19-Related Project EnhancementDuring COVID-19, pregnant and parenting women with OUD may find it hard to get substance use treatment. They also have an increased risk of domestic violence and may have more anxiety due to the virus, childcare, or remote school.
With this enhancement, the research team will identify how health systems adapted care for women with OUD and other substance use disorders in response to COVID-19. For example, many health systems have shifted from in-person care to telehealth. Telehealth provides care to patients remotely using phone, video, or other devices to help manage care. The team will look at maternity, addiction, and mental health care. They will assess women’s and providers’ experiences. Results will inform improvements in care.
Enhancement Award Amount: $491,910
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This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.
What is the research about?
Opioid use disorder, or OUD, increases health risks for pregnant women and their babies. Babies born to women with OUD may be born early, be underweight, or have withdrawal from opioids. In Maine, New Hampshire, and Vermont, between 5 and 8 percent of newborns have mothers with OUD.
Medication-assisted treatment, or MAT, can reduce the risk of complications for women with OUD and their babies. But it can be hard for pregnant women to find doctors who offer MAT. This study is comparing two ways for pregnant women to receive MAT for OUD. One way is for clinics that care for pregnant women to provide MAT during patient visits. A second way is for these clinics to refer women to clinics that specialize in treating OUD. The study is also looking at what other types of services, such as mental health treatment, are most useful in helping women continue treatment for OUD.
Who can this research help?
Clinics, doctors, nurses, and others can use results from this study when considering the best ways to provide MAT to pregnant women with OUD.
What is the research team doing?
The research team is recruiting 2,000 pregnant women with OUD who get care at 21 maternity clinics in rural and suburban areas across Maine, New Hampshire, and Vermont. Some of the maternity clinics provide MAT for OUD on-site. Others refer patients to different clinics to get MAT for OUD.
The research team is checking the women’s health records to see if they have problems with their pregnancies and whether their babies have opioid withdrawal. In addition, the team is collecting data about services the clinics offer, like parenting classes or mental health care. Finally, the team is using surveys and interviews to ask doctors at the 21 clinics about their views on the two ways of offering MAT to pregnant women with OUD.
The research team is using the data they collect to compare the health results for women and their babies. The team is talking to a smaller group of women six months after their babies are born about
- Depression, anxiety, quality of life, and their experience with the care they received
- Their pregnancy and any complications
- Whether they are in treatment for OUD during pregnancy and shortly after giving birth
- Whether they keep custody of their babies
- Whether they bring their babies in for the recommended visits
The research team is also looking at what makes a difference in whether pregnant women continue OUD treatment. These things may include mental health concerns, the medicine used for treatment, and the severity of OUD. They are also looking at what other maternity clinic services, like counseling, care coordination, or parenting education may improve health results for pregnant women. Finally, the team is looking at how maternity care doctors’ views about treating OUD with medicine affect pregnant women’s health results.
Women who have had OUD during pregnancy, clinicians, insurers, and addiction recovery counselors are working with the research team to plan and conduct the study.
Research methods at a glance
| Design Element | Description |
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| Design | Observational: mixed-methods study |
| Population | Pregnant adults who receive prenatal care from a participating clinic and meet DSM-5 diagnostic criteria for OUD |
| Interventions/ Comparators |
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| Outcomes |
Primary: illicit opioid use, MAT treatment engagement and retention during pregnancy and early postpartum, pregnancy and complications, depression and anxiety, experience of care Secondary: other illicit substance use, neonatal complications, infant treatment for neonatal withdrawal, maintenance of child custody, quality of life, adherence to recommended infant care visits |
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6-month follow-up for primary outcome |
Project Details
Care Coordination
Other Health Services Interventions
Training and Education Interventions
Rural
Women
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.