A new national registry has been launched by specialists in obstetrics, gynecology and reproductive sciences at UCLA Health and the University of California, San Francisco, to determine COVID-19's possible effects on pregnant women and newborns.
The registry is enrolling pregnant women and those who have been pregnant or postpartum within the past six weeks who have a confirmed diagnosis of COVID-19 or are being evaluated for that possibility. UCLA Health's participation is aligned with the goals of UCLA Biodesign, a program that promotes health care innovation and partnerships that develop novel tools and technologies.
Within two weeks of going live, it had received more than 400 patient referrals from around the country.
The novel coronavirus quickly gained a reputation for being particularly dangerous to the elderly and those with preexisting medical conditions, but little is known about its potential impact on the course of pregnancies. The PRIORITY study – Pregnancy CoRonavIrus Outcomes RegIsTrY – is enrolling pregnant women and those who have been pregnant within the previous six weeks who have a confirmed diagnosis of COVID-19 or are being evaluated for that possibility.
"We expect this registry to provide data that will be critical in helping to improve care for pregnant women during this global pandemic," said Yalda Afshar, MD, PhD, an obstetrician/gynecologist at UCLA Health and a UCLA Biodesign Fellow, who is co-principal investigator of the study.
Although it usually takes many months to develop a national registry, because of the rapidly evolving COVID-19 crisis, the PRIORITY study went from the initial concept to being open for enrollment in two weeks.
"It was a call to arms because we have a population of vulnerable folks for whom we have no data," said Afshar.
According to Afshar, most of the available COVID-19 data are based on studies of the general population, but these data do not translate meaningfully to pregnant women and their babies.
"Pregnancy in and of itself makes significant changes to the physiology of the body," Afshar said. "In fact, pregnant women are considered immune-compromised. An infection on top of that results in a potentially very different scenario for both mom and baby. We wanted to have data relevant to women, for women, so we can take care of them better," Afshar said.
"With the global reach of this disease, the findings resulting from this work have the potential to impact millions of lives in an entire generation" said Johnese Spisso, president of UCLA Health, CEO of UCLA Health System, associate vice chancellor of UCLA Health Sciences, and a member of the UCLA Biodesign Program Advisory Board.
History suggests that the virus will make some pregnancies and deliveries more challenging.
"We know that in previous outbreaks of the regular flu, for example, there have been more deaths and poorer outcomes among pregnant women compared with nonpregnant women," Afshar said. Infection with influenza also is known to increase risk of miscarriage, preterm delivery, fetal death and certain congenital abnormalities.
Afshar, a physician-scientist whose interests include high-risk pregnancy, prenatal ultrasound, genetic testing and congenital heart disease, is overseeing the study with Drs. Stephanie Gaw, Vanessa Jacoby, and Valerie Flaherman, at UCSF where the registry data will be coordinated.
"In addition to gaining a better understanding of the course of the disease, we will investigate disease transmission to determine if it can be passed from a mother to her baby in utero, and during the postpartum period, such as in breast milk, said Gaw, whose research interest is infectious disease during pregnancy and is leading the bio-specimen core of the study.
"These are questions that we really have no guidance for right now,' Afshar added. "We're creating protocols on labor and delivery units throughout the country – throughout the world – without really knowing if this is acquired in utero or not."
Jacoby agreed. "There is an urgent need to address significant gaps in our knowledge about how pregnant women infected with COVID-19 will fare during pregnancy and how the disease may affect outcomes," she said.
Beyond that, there also is a critical need to understand the affect of health disparities during this pandemic and how some pregnant women, particularly Black and Latina women, may be impacted more severely by COVID-19.
"A central part of the UCLA Biodesign mission is to deliver improved outcomes to patients locally and worldwide. This registry is a perfect example of the way we're working with leaders in our state and throughout the nation to improve health care throughout the world," said Jennifer McCaney, co-executive director of the program.
Desert Horse-Grant, senior director of UCLA Health Research and Innovation and co-executive director of UCLA Biodesign, added that UCLA Biodesign is structured to be both transformative and nimble, with the ability to adapt quickly in a rapidly changing world.
"To have a registry up and running in two weeks is a testament to the foresight, professionalism, expertise and dedication of Dr. Afshar and her colleagues, who recognized the significance of this problem and quickly pivoted to take it on," Horse-Grant said. "Even a healthy pregnancy brings its own unique stressors; imagine adding those to the life-threatening issues the pandemic has created. This important initiative is an opportunity for us to gather valuable health information and learn how best to protect this vulnerable population."
Women 13 and older, recruited through their health care practitioners – family physicians, midwives and obstetricians – throughout the U.S., will be contacted by phone by a study coordinator. Patients also may enroll in the study without a referral by visiting the website.
After enrolling, patients will complete questionnaires online, by phone or email to provide information on their symptoms, clinical course, pregnancy outcomes and neonatal outcomes. Researchers will collect data regularly from the time of enrollment through the second and third trimesters and postpartum, with the goal of following the mothers and babies up to one year. In addition to the questionnaires, the registry will obtain necessary medical records to collect data on key clinical and pregnancy outcomes.
Patients interested in information about the registry may contact the researchers by emailing Afshar at [email protected]. She has also created a "COVID-19 in Pregnancy" video with additional information.