The George Washington University Milken Institute School of Public Health is leading a new $4.8 million project funded by the Bill & Melinda Gates Foundation aimed at capturing and harmonizing data to improve global understanding of key risk factors for adverse maternal and newborn health outcomes.
Emily R. Smith, an assistant professor in the departments of global health and exercise and nutrition sciences, is the project’s principal investigator. Access to maternal, newborn and infant services is integral to reducing adverse pregnancy-related health outcomes and promoting positive pregnancy experiences, Smith said. High-quality care before, during and after birth is not universally available, however, especially for vulnerable populations and in low- and middle-income countries.
The Pregnancy Risk Stratification Innovation and Measurement Alliance (PRiSMA) Maternal and Newborn Health (MNH) study aims to develop a robust harmonized dataset to evaluate pregnancy risk factors, better estimate the global burden of disease for women and children and inform research and development of new health interventions, Smith said. This project will focus specifically on working with Gates Foundation-funded partners in Ghana, India, Kenya, Pakistan and Zambia, where comprehensive data about pregnant women and newborn health is limited.
“The goal is to have really detailed, clinical data and to have it be the same across countries,” Smith said. “We can talk about maternal mortality, but we need to actually understand the primary causes of maternal mortality and morbidity in a specific context to better understand the burden of disease and how to address it.”
This study will capture data on pregnancy risk factors and maternal and newborn health outcomes for an estimated 8,000 annual deliveries over three years. Researchers will collect detailed clinical data from all women in a standardized way across countries—capturing ultrasound exams, laboratory tests related to infectious disease, micronutrient malnutrition, exposure to environmental contaminants, and clinical information like maternal weight gain, blood pressure and heart rate. They will also check for pregnancy complications including diabetes and anemia, and follow the newborn’s progress after birth.
Researchers also will collect qualitative data to understand what women value when it comes to their health and health care.
As the coordinating center for the study, GW will support consistent study implementation across the five countries and oversee project data infrastructure. The GW team will establish uniform approaches to data analysis and dissemination of primary study results, and support cross-consortium capacity building efforts related to data management, data analysis, and scientific writing and publishing.
“For every outcome, there's a specific definition and specific way of measuring it that might not be part of the standard of care right now,” Smith said. “We're working across countries to determine what's feasible, and where we can, to use the gold standard assessment for diagnosis and measurement.”
GW faculty James Tielsch, professor and chair of the Department of Global Health, Jennifer Seager, assistant professor of global health and economics, and Qing Pan, professor in the Columbian College of Arts and Sciences Department of Statistics, will serve as co-investigators on the project.
“Through our scholarship and research, we aim to have a global impact and advance society as a whole,” said GW President Mark S. Wrighton. “We are grateful to the Bill & Melinda Gates Foundation for this grant, which will allow our public health and statistics researchers to conduct this critical work aimed at improving maternal and newborn health outcomes globally.”
Lynn R. Goldman, the Michael and Lori Milken Dean of the Milken Institute SPH, said the university is honored to receive this grant and serve as the coordinating center for this project.
“Globally, adverse reproductive and infant health outcomes are significant causes of excess mortality and ill health,” she said. “Improving pregnancy and infant health surveillance in these countries is a significant step forward, and we are proud that Dr. Emily Smith has been selected to coordinate the protocols and data."
Donna Arbide, vice president of development and alumni relations, said that philanthropic funding from foundations is essential to solving the world's seemingly intractable challenges. “Receiving this highly-competitive funding is a testament to the strength and caliber of GW’s deep expertise in global health research and policy,” Arbide said.
Smith said that population-based baseline estimates of key maternal and child health outcomes gathered in this study may inform future interventions and randomized trial study designs. Data will also enable application of machine learning and novel techniques to create risk prediction tools.
The project team anticipates that data collected through the study will influence and inform policy changes at the World Health Organization. For example, there is some indication from preliminary data that the existing hemoglobin threshold used to define anemia in pregnancy is slightly too high, and Smith anticipates this global threshold could be changed as a result of this study. Researchers will work closely with a technical advisory group throughout the project to ensure robust data collection protocols and analysis are followed. In working with key stakeholders and policy makers from the beginning, the research team hopes to collect high-quality data that is needed to guide decision-making.