UB and Oishei Hospital Part of Clinical Trial on Pregnancy-Related Hypertension

The study will enroll 6,000 postpartum women from priority populations — mostly Black and Latinx women — in three medical centers: Yale New Haven Hospital, UMass Medical Center and Kaleida Health’s John R. Oishei Children’s Hospital.

The project is being funded through a $18.8 million grant from the Patient-Centered Outcomes Research Institute (PCORI), with UB receiving $3.7 million. Study recruitment is underway.

“Women who have hypertensive disorders during pregnancy are at higher risk throughout their lives for adverse cardiovascular outcomes,” says Vanessa Barnabei, MD, professor emerita in the Department of Obstetrics and Gynecology in the Jacobs School of Medicine and Biomedical Sciences, who played a critical role in securing the funding for UB before retiring.

The adverse health impacts have a more profound effect for Black, American Indian/Alaskan Native and Latinx women due to social determinants of health.

“Maternal health is one of the most important health priorities for the African American community. Hypertension, as well as the social determinants of health, have created unacceptable birth outcomes in the community,” says the Rev. George F. Nicholas, pastor of Lincoln Memorial United Methodist Church in Buffalo and co-convener of the African American Health Equity Task Force, a partner on the research project.

“This grant will enable us to obtain important information on how to improve birth outcomes for women and children in the community,” Nicholas says.

“This study takes a patient-centered approach focusing on patient needs and preferences of care delivery with the hope of improving the physical health and mental well-being of women while also addressing health care inequities in our community,” notes Pamela D. Reed, MD, senior research project director for the study.

“Funding for this type of work is so important if we are to decrease the inequities in our current health care delivery system,” Reed adds.

The UB investigators on the research project are:

• Thaddeus P. “Ted” Waters, MD, Amol S. Lele Clinical Professor and division chief of maternal-fetal medicine in the Department of Obstetrics and Gynecology, Jacobs School. He is also medical director for the maternal-fetal medicine and regional perinatal program at Oishei Children’s Hospital.
• Pauline Mendola, PhD, chair of the Department of Epidemiology and Environmental Health, School of Public Health and Health Professions

Other UB collaborators include Michael J. LaMonte, PhD, research professor, and Lina Mu, PhD, associate professor, both in the Department of Epidemiology and Environmental Health; and Heather Link, MD, clinical assistant professor, and J’Leise Sosa, MD, clinical assistant professor of obstetrics and gynecology, from Kaleida Health.

The study is being led by the Yale School of Public Health.

Researchers will compare with the current standard of care, and with each other, the effectiveness of two health care delivery models focused on early detection and control of postpartum hypertension, as well as the social and mental health factors known to impact maternal outcomes. The two models are:

• A remote medical model that incorporates standard procedures along with home blood pressure monitoring and treatment, weekly virtual visits from a medical professional for six to 12 weeks, and screening for social determinants of health and anxiety/depression, with referrals for mental health services if needed.
  
• A community health model, which incorporates standard of care and the remote model with community health workers trained in a strength-based, trauma-informed approach that respects the influences of a patient’s past experiences when addressing their current health needs.

“The goal of the study is to have a lasting impact on long-term health,” Waters said. “If the study is successful, the model used in the trial can be brought to more patients and meaningfully address post-delivery morbidity and mortality, which disproportionately affects our community.”

A key part of the study calls for leveraging a community-based approach toward treating postpartum women. The community health worker model has been recognized by the World Health Organization and other agencies for its effectiveness in addressing health inequities due to the fact that community health workers are uniquely poised to play a role in providing better care by sharing the language, socioeconomic status and life experiences of their clients.

“The incorporation of the community health care worker is a model for the future,” Waters says. “We believe this study will demonstrate the value of this approach by addressing the gaps in care for patients at high risk of complications after delivery and improving long-term outcomes related to cardiovascular and mental health.”

Researchers will be working with project partner Cicatelli Associates Inc. (CAI), a New York-based nonprofit with a local Buffalo office that helps organizations improve health care and social services for marginalized communities.

CAI will be central to the delivery of asynchronous e-learning modules and synchronous virtual instructor‐led trainings to the health care providers and community health workers and doulas involved in study. Sample training topics will include the impact of systemic racism on health disparities among women and pregnant women, and trauma through an anti‐racist lens to understand sensitivity and reactivity to stress within the study population.

“Pregnancy risks are unacceptably high among women in priority populations who have been historically underserved and who have experienced discrimination and racism,” says Lindsay Senter, CAI vice president of research and evaluation. “We are thrilled to take part in groundbreaking research that places community voices front and center to ensure that members of marginalized communities are engaged and have a voice in creating the systems that serve them.”

The team will recruit and train community health workers to perform mental health assessments and work with patients directly in their neighborhoods. Nurse practitioners will conduct follow-ups with patients who’ve been identified as having continued high blood pressure postpartum to set them up with additional treatment.

In addition, CAI is leading development of a local community advisory board to help inform the implementation of the trial.

The study’s primary objective is to improve clinical outcomes, including mental health outcomes, among postpartum, at‐risk women experiencing health disparities by increasing awareness, detection and timely care of postpartum hypertension, mental health and cardiovascular complications.

“This is a topic that is near and dear to my heart,” Mendola notes. “Postpartum is a very vulnerable time, and it is really important for women’s health and neonatal health, yet it doesn’t get the attention that it really deserves due to its long-term health impacts. We as a clinical community are excited about the opportunity to address some of these issues and help women during a time in which they really need that help but have trouble accessing it.”

The focus on women who identify as Black, Latinx or American Indian/Alaska Native is especially significant, Mendola says. “This study provides another avenue to try to address the striking disparities in maternal mortality and morbidity by race. Black moms are two to three times more likely to die from hypertension during pregnancy than white moms, and their hypertension typically occurs at a much higher rate than mothers of other races and ethnicities.”

Hypertension, or high blood pressure, as well as mental health, are of particular concern during the postpartum period, especially since most new mothers will receive checkups only at two and six weeks postpartum. In fact, at Oishei Children’s Hospital, the numbers continue to climb: In 2021, 16% of women who gave birth there had one of the four types of high blood pressure during pregnancy, up from around 5% in 2009.

“This is a really key time in women’s lives, and it makes a difference for their lifespan and continued health,” Mendola says. “Some of the things we may be able to address in this study and deal with in a proactive way will help improve the women’s cardiometabolic health for the rest of their lives.”

Leadership at Oishei Children’s Hospital is thrilled the hospital was chosen to be one of the three study sites.

“As the region’s only state-designated Regional Perinatal Center, Oishei Children’s Hospital provides the most comprehensive specialized care for our community’s highest risk moms and babies,” says Stephen J. Turkovich, MD, president and chief medical officer of Oishei Children’s Hospital.

“Beyond the four walls of the hospital, our robust network of maternal-fetal medicine specialists and community-based clinics are uniquely positioned to provide complex care services for pregnant moms throughout Western New York. I’m optimistic that through investments in research and alternative care models for postpartum at‐risk women, we can help close the health-disparities gap and improve health outcomes,” says Turkovich, a clinical assistant professor of  pediatrics at the Jacobs School.