Collaborative Action for Research to End Stillbirth (CARES) - PROJECT SUMMARY Stillbirth is far too common in the U.S. with 20,000 stillborn babies every year with large racial and ethnic disparities. Black birthing individuals have twice the risk of stillbirth compared to White individuals. The Collaborative Action for Research to End Stillbirth Research Center (CARES) will conduct innovative, integrated, multilayered research - with and for people with lived experience of stillbirth squarely at the center- to develop and implement actionable strategies to improve the prediction of stillbirth early in pregnancy and to understand reasons for the excess risk for Black birthing individuals. We propose to address a critical area in stillbirth care – early identification of patients at highest risk for stillbirth to facilitate prevention. Screening patients early in pregnancy is important as 63% of stillbirths occur before 32 weeks of gestation. Joining efforts from researchers across essential disciplines, people with lived experience of stillbirth, and community, public health, and health care stakeholders, CARES will address the following Specific Aims: Aim 1. Establish a strong infrastructure to support stillbirth research and collaboration across the consortium. With input from the CARES Stakeholder Advisory Board and the CARES Parent Advisory Board, we will develop and maintain a core team of investigators, collaborators and staff with expertise essential for a broad range of stillbirth-related research. We will also build shared resources to promote interdisciplinary team science and ensure access to a diverse patient population to facilitate stillbirth research. Aim 2. Develop a scalable, electronic health record (EHR)-based, dynamic risk prediction model for stillbirth. Inadequate data sources have been identified as a major barrier to advancing knowledge on stillbirth and its prevention. We will (2a) Ascertain patients’ and health care professionals’ perspectives on risk factors for stillbirth (overall and for Black birthing individuals specifically), data needs for stillbirth research, and the acceptability and design of a mobile app-based patient data reporting tool to support pregnancy monitoring and stillbirth prediction; (2b) Develop and validate EHR-based and artificial intelligence-powered algorithms for automated identification and characterization of stillbirth, measurement of stillbirth risk factors, and prediction of stillbirth risk scalable across institutions; (2c) Develop and test a mobile app for patient-reporting of pregnancy information to augment EHR data and support pregnancy care. Aim 3. Develop novel markers of underlying incipient placental dysfunction early in pregnancy for predicting stillbirth. Fetal growth restriction (FGR) is a major antecedent to stillbirth with the most common underlying pathogenesis being placental dysfunction. Accurate identification early in pregnancy and management of FGR could potentially make an impact on stillbirth prevention. We will conduct a prospective cohort study to investigate innovative (3a) placental imaging before 14 weeks’ gestation, (3b) placental biomarkers, and (3c) fetal genetic markers for predicting fetuses at greatest risk for stillbirth. CARES will use multifaceted approaches applicable to the entire population of birthing people to prevent stillbirth.
