PRIORITY Study Hopes to Provide Answers about the Impact of Coronavirus on Pregnant Women

When the novel coronavirus began spreading in the United States, there were many unknowns about its effects, its spread and its lasting impact on different populations. One of the more crucial questions needing answers was the effect of COVID-19 on pregnant women and their newborns.

Are pregnant women more likely to experience severe symptoms? Will they pass the virus to their fetus during pregnancy or to the baby during birth? Does the virus transmit through breastmilk? What is the long-term impact of COVID-19 on maternal and child health in the year after birth? These questions and many more are what the co-principal investigators of the Pregnancy Coronavirus Outcomes Registry, or PRIORITY, hope to answer.

PRIORITY is a nationwide study of pregnant or recently pregnant women who have confirmed infection with COVID-19 or are under investigation for the infection. The study, which received initial support by the CDC Foundation, looks to understand COVID-19 effects on the health of pregnant women during pregnancy and birth, their mental health, the economic impact on these women, and how health inequities effect the care received and their infection outcome. As part of this study, researchers will follow women during the entire pregnancy and for a year after the pregnancy ends to see if health conditions linger, and if there is any long-term impact on baby’s health.

The study is being carried out by a collaboration of researchers at the University of California, San Francisco and the University of California, Los Angeles. The group of investigators are multi-disciplinary with expertise in obstetrics, pediatrics, public health and health disparities. They share one common goal: understanding how COVID-19 effects pregnant women and their babies and how to better care for infected patients. The study is being led by Dr. Vanessa Jacoby, an obstetrician gynecologist, Dr. Stephanie Gaw, a perinatologist and infectious disease researcher, Dr. Valerie Flaherman, a pediatrician, and Dr. Yalda Afshar, a perinatologist from UCLA.

“There are so many unanswered questions, so we need to understand the disease process through the pregnancy and even after,” said Gaw, who leads the Biospecimen Collection Core, which hopes to answer biological questions about the virus and disease impact on the mother and baby through the collection and analysis of relevant clinical samples.


From All-Call to Focused Enrollment

Through previous research, according to Jacoby, and long before the beginning of coronavirus, many health inequities existed in maternal health. For instance, African American women are three to four times more likely to die from complications related to pregnancy than white women. Researchers believe that COVID-19 has only widened these health inequities.

Thus, it is even more important now to enroll pregnant women of different race and ethnicities, but more importantly Latinx, Black, and Native American pregnant women who are even more significantly impacted by COVID-19. PRIORITY has a Reproductive Health Equity and Birth Justice Core led by five co-investigators that aims to assure representation of these women among the study population. This Core also supports a Community Advisory Council to assure that research questions addressed in PRIORITY are aligned with the priorities of the most highly impacted communities.

There are so many patients and providers who need this information now. We decided to be as transparent as possible...It is novel for a study to do this, but we think this openness is imperative right now.

When the study started, the researchers were enrolling anyone who was pregnant or recently pregnant and a confirmed case, or pregnant and under investigation. “We enrolled over 1,000 participants, but we wanted to ensure the population accurately represented those most affected by COVID-19,” says Jacoby. “We decided we needed to focus enrollment on Black, Latinx and Native-American women, so we are accurately capturing who is affected and can evaluate reasons for widening health inequities.”

Another unique aspect of their study—women can enroll if they speak almost any language because of the many translators helping with enrollment that are multilingual and bicultural. “About 50 percent of the women in the study are self-referred, and we have recruited from every single state except one,” noted Jacoby.

“The response has been amazing but there have been disproportionately more women from urban areas. We are actively working on reaching people who have been challenging to reach in prior national studies, they may not have access to websites or know this study exists, and we want to assure they can participate,” said Gaw.


Breaking New Ground—and Sharing It

The researchers are proud of this groundbreaking study, as there is not another registry available that is so vast, provides real-time data and encompasses health professionals with such a diverse array of specializations. For example, there is representation from nurses to biostatisticians to pediatricians. “We have different training, experience and expertise, when combined this makes for a strong multidisciplinary study,” said Jacoby, who is leading the coordinating center which is responsible for recruiting and enrolling participants, data analysis and data management.

While more is being learned each day about COVID-19, there are still many unknowns, which this study is working to answer. The study website has a dashboard that shows real-time data with characteristics on who is enrolling in the study. The website also has all study materials available to download.

“There are so many patients and providers who need this information now,” said Jacoby. “We decided to be as transparent as possible. We decided that in the time of COVID-19 we should be open, share all the questionnaires publicly and show when and where the data is being collected. It is novel for a study to do this, but we think this openness is imperative right now.”

When this study began, many people believed that pregnant women weren’t getting sick, but now because of this study and the sharing of real-time data, they know that pregnant women are impacted in many different ways and in communities across the country.

“We received early support from CDC Foundation, so we were able to begin assessing COVID-19 effects on pregnant women in real time,” says Gaw. “This study is bringing attention to pregnant women; they are such a huge part of the population and when we know so little, it’s important that we understand this better.”

Display Date