The research will focus on the birth outcomes of Black, Latinx and low-income populations hit hardest by COVID-19.
ENROLL
As Centers for Disease Control and Prevention (CDC) data emerges showing that the COVID-19 infection and the pandemic may place pregnant women and their infants at increased risk for complications and sickness, University of California researchers have launched a novel study to generate data to help mitigate the impact of COVID-19 and pandemic-related hardship on pregnant persons.
Researchers at the UC San Francisco (UCSF) Preterm Birth Initiative and UC San Diego (UCSD) Department of Pediatrics are leading the HOPE (Healthy Outcomes of Pregnancy for Everyone) COVID-19 study, and invite all pregnant women worldwide to join the study – regardless of a positive screen for infection or not. This first-of-its-kind approach will allow investigators to examine patterns of outcomes in women and infants with and without infection and to examine how pandemic-related stress and hardship may be influencing outcomes in women and infants with and without infection. The protocol for study was published today in the journal Reproductive Medicine.
We need to know how pandemic-related hardship like loss of income, social isolation, and persistent discrimination and racism are impacting women and families. Then we can figure out how to help.
Laura Jelliffe-Pawlowski, HOPE COVID-19 Principal Investigator
California Preterm Birth Initiative
Understanding how COVID-19 impacts oppressed groups
Central to this study is an examination of how pandemic-related hardships like social isolation, job loss and family member sickness or death, may be impacting outcomes and how illness and hardship are being felt especially hard in Black, Latinx and low-income groups. Black, Latinx, and low-income populations in the United States have the multiple intersecting burdens of being disproportionately impacted by preterm birth and maternal and infant mortality, COVID death and COVID-related hardship such as unemployment, homelessness and lack of resources, and are more likely to experience toxic stress and disrespectful care as a result of structural and interpersonal racism. Investigators hope to identify which women are more likely to experience adverse birth outcomes and how COVID-19 infection and hardship might influence these relationships.
Donate
The study is also taking donations to help with its efforts.
How the study works
The researchers will enroll 10,000 birthing persons over a two-year period. There are two groups of participants. One group of 7,500 women worldwide will complete surveys only throughout their pregnancy and 18 mos. after birth. A second group of 2,500 women over this same time period will participate in surveys plus testing, which will start in California with possible expansion to Oregon, Washington State and elsewhere depending on funding.
All HOPE COVID-19 participants co-enroll in the UCSF Citizen Science Study (CSS) which will allow for the collection of daily symptoms and experiences through a smartphone app. Women will also measure their heart rate as an indicator of infection and stress. Participants in the survey plus testing group will also be tested for the COVID-19 related virus (SARS-CoV-2) and related antibodies during pregnancy and after birth as well as receive testing focused on inflammation.
The study team
The HOPE COVID-19 study is led by Dr. Laura Jelliffe-Pawlowski, PhD, MS, Professor of Epidemiology & Biostatistics and Director of Discovery and Precision Health with the UCSF California Preterm Birth Initiative (PTBi-CA) in the UCSF School of Medicine and by Dr. Christina Chambers, PhD, MS, Professor of Pediatrics and Director of Clinical Research for the Department of Pediatrics at UCSD and Rady Children's Hospital.
Dr. Larry Rand, MD, Marc and Lynne Benioff Endowed Chair in Maternal-Fetal Medicine at UCSF and Principal Investigator for the California Preterm Birth Initiative (PTBi-CA) is the Lead of Maternal and Fetal Clinical Investigation for the study. Dr. Elizabeth Rogers, MD, Chief Experience Officer for the UCSF Department of Pediatric and Director of the Intensive Care Nursery ROOTS Small Baby Program is the Lead of Newborn and Pediatric Clinical Investigation. Dr. Karen A. Scott, MD, MPH, FACOG, Associate Professor in the UCSF Department of Obstetrics, Gynecology & Reproductive Sciences is the Lead of Nativity, Racism and Racial Inequities Investigations. Drs. Dr. George Rutherford, MD and Dr. Krysia Lindan, MD, MS, serve as lead consulting faculty for SARS-CoV-2 and COVID-19.
Investigators from multiple other departments in the UCSF School of Medicine are also included in the study including from Cardiology and Psychiatry. All laboratory investigations are led by Dr. Brian Piening, PhD, at Providence St. Joseph’s Health in Portland Oregon.
The HOPE COVID-19 study has received initial seed funding from the UCSF PTBi-CA, from the San Diego Study of Outcomes in Mothers and Infants (SOMI) study and from the UCSF Newborn Brain Research Initiative (NBRI).
Other relevant UCSF studies on COVID and pregnancy
Other studies currently underway at UCSF include the PRIORITY study, which looks specifically at outcomes in women with a positive test for SARS-CoV-2 or who are presumed positive and the ASPIRE study, which looks specifically at the impact of the SARS-CoV-2 virus in early pregnancy. The UCSF SACRED Birth in the time of COVID-19 ([email protected]) study is also expected to this summer and focuses specifically on measuring the experiences Black pregnant women in hospitals during the pandemic.
Enrolling in HOPE COVID-19
Pregnant women who are interested in joining the HOPE COVID-19 study can find out more information on the HOPE COVID-19 website where if they qualify and are interested, they can sign up and start participating immediately.
