Project Summary
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?
In the United States, about 10 percent of babies are born premature, which is before 37 weeks. Premature babies have physical and mental problems more often than babies born at full term, and they are at higher risk of dying as newborns. Women with low incomes, and women who are black, Latina, or Native American or Pacific Islander are more likely to have a premature baby than other women.
Having depression or anxiety or experiencing racism while pregnant may raise a woman’s chances of having a premature baby. This study is comparing two programs that provide care to pregnant women with low incomes to see how the programs affect premature births and women’s mental health and care experiences.
Who can this research help?
Clinics may be able to use the findings when considering ways to improve health care for pregnant women at risk for having a premature birth.
What is the research team doing?
The research team is working with 10 health clinics that serve racially and ethnically diverse patients in Fresno County, California. They are enrolling 2,600 women who are less than 24 weeks pregnant, speak English or Spanish, and are eligible for Medicaid.
Each clinic is offering the two prenatal care programs and assigning women to one of them based on their due date. In the first program, called Glow!, women with similar due dates receive pregnancy care in a group. In the second program, the Comprehensive Perinatal Services Program, or CPSP, women receive one-on-one pregnancy care. They also meet with CPSP staff up to three times to report on their health and living situation. In both programs, women have 7–11 prenatal care visits. Both programs offer services for depression, anxiety, smoking, drug and alcohol use, and health problems that could be dangerous during pregnancy.
Women in the study are completing surveys about their physical health, mental health, and care experiences when they enroll in the study, during their third trimester, and three months after they give birth. The research team is looking at women’s medical records to find out whether their baby was born premature. The team is also conducting in-depth interviews with some black and Latina participants to learn more about their care experiences.
A study advisory group is helping the research team plan and carry out the study. It includes women who received prenatal care in one of the programs, clinicians, and community organization representatives.
Research methods at a glance
| Design Element | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | Women who are less than 24 weeks pregnant, speak English or Spanish, and are eligible for Medicaid |
| Interventions/ Comparators |
|
| Outcomes |
Primary: premature birth rate Secondary: anxiety, depression, satisfaction with care, perceptions of respectful care |
| 3-month follow-up after birth for primary outcome |
COVID-19-Related Study
Summary
In response to COVID-19, prenatal care has shifted from all in-person appointments to a combination of in-person and telehealth appointments, using phone, video, or other devices that help manage care.
With this enhancement, the research team wants to learn whether group prenatal care using telehealth works well for women with low incomes, particularly those who are Black or Latina. Working with the advisory group, the team will adapt their group prenatal care model for telehealth. The team will ask women who’ve had prenatal care during the pandemic about:
- Getting prenatal care via telehealth
- How well they were able to monitor care at home
- How satisfied they were with their care
They will also talk with healthcare providers, payers, and people from community agencies. Results will be used to test whether the telehealth group prenatal care is feasible and acceptable.
Enhancement Award Amount: $499,930