Specialists in obstetrics, gynecology and reproductive sciences at UCLA Health and UC San Francisco have set up a national registry to determine COVID-19's possible effects on pregnant women and newborns and are enrolling patients, it was announced Thursday.
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.
Within two weeks of going live, the registry had received more than 400 patient referrals from around the country, according to Dr. Yalda Afshar, an obstetrician/gynecologist at UCLA Health and a UCLA Biodesign Fellow, who is co-principal investigator of the study.
"We expect this registry to provide data that will be critical in helping to improve care for pregnant women during this global pandemic," Afshar said.
It usually takes many months to develop a national registry, but because of the rapidly evolving COVID-19 crisis, the PRIORITY study went from the initial concept to being open for enrollment in two weeks, the doctor said.
"It was a call to arms because we have a population of vulnerable folks for whom we have no data," Afshar said.
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"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."
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," Gaw said.
"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 said there's "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."
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The doctors said there also is a critical need to understand the affect of health disparities during the pandemic and how some pregnant women, particularly black and Latina women, may be impacted more severely by COVID-19.
"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.
Teens and 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 PRIORITYCOVID19@ucsf.edu.