Jill Schechter, with baby Jonah, says she was grateful to participate in the study of COVID-19 and pregnancy.
A multidisciplinary team at Mount Sinai is conducting the first large-scale prospective study to examine the impact of COVID-19 infection during pregnancy on maternal and child outcomes. The study is funded by a $1.8 million contract from the Centers for Disease Control and Prevention (CDC) and is expected to be conducted through May 2022. The team calls it “Generation C” because it is studying the maternal experience during the COVID-19 pandemic.
“Early in the pandemic, there were reports that women who tested positive during delivery might have a higher risk of birth complications,” says a co-investigator, Veerle Bergink, MD, PhD, Professor of Psychiatry, and Obstetrics, Gynecology and Reproductive Science, Icahn School of Medicine at Mount Sinai. “We want to know, not only for symptomatic women but also for the asymptomatic women, what exposure to COVID-19 means for your obstetric outcomes and for your baby.”
The research team intends to recruit a cohort of 3,000 pregnant patients at The Mount Sinai Hospital and Mount Sinai West, with more than 2,500 enrolled to date.
One participant in the study is also a co-investigator—Whitney Lieb, MD, MPH, MS, Assistant Professor of Obstetrics, Gynecology and Reproductive Science, Population Health Science and Policy, and Medical Education, Icahn Mount Sinai. “There is limited data about how COVID-19 affects moms and babies, and I think it is important to get as much data as possible,” says Dr. Lieb, who gave birth at Mount Sinai West in July 2020. “That is why I decided to join the study.”
Whitney Lieb, MD, with baby Jacob, is both a participant and a co-investigator in the study. “There is limited data about how COVID-19 affects moms and babies,” says Dr. Lieb, Assistant Professor of Obstetrics, Gynecology and Reproductive Science, Icahn School of Medicine at Mount Sinai.
Jill Schechter, who gave birth on Valentine’s Day at The Mount Sinai Hospital, joined for the same reason. Ms. Schechter was vaccinated for COVID-19 while pregnant and asked her physician if there were any studies she could participate in. “I work in health care, and I am aware of the importance of research,” Ms. Schechter says. “I’m grateful for being able to participate.”
In the study, researchers are examining plasma samples drawn as part of routine care at each trimester of pregnancy in all pregnant women at the two hospitals. Samples are tested for the immunoglobulin M and immunoglobulin G antibodies to SARS-CoV-2, the virus that causes COVID-19, at each trimester of pregnancy and delivery. The team is measuring a panel of inflammatory biomarkers at each trimester of pregnancy and at delivery. The hypothesis is that the level of inflammatory host response to SARS-CoV-2 exposure is related to the impact of the infection on maternal and child outcomes, and that timing is crucial.
The study is examining the subjects’ electronic medical records, obtaining data on obstetric complications, miscarriage, premature rupture of membranes, delivery type, maternal ICU admissions, acute respiratory distress syndrome, sepsis, and maternal death. In addition, the team is extracting data on fetal growth and neonatal outcomes, including birth weight, preterm birth, neonatal morbidities, neonatal intensive care admissions, congenital malformations, and fetal and neonatal death.
“We are looking at the impact and timing of SARS-CoV-2 infection and the development of COVID-19 on these acute and severe complications,” says co-principal investigator Joanne Stone, MD, Director of the Division of Maternal Fetal Medicine, Mount Sinai Health System, and Professor of Obstetrics, Gynecology and Reproductive Science. “The aim is to investigate whether SARS-CoV-2 infection and a strong inflammatory host response are related to preterm delivery and neonatal morbidity.”
Another aim of the study is to examine the extent to which COVID-19 disproportionately impacts pregnant women from underserved communities. This part of the study is taking full advantage of the diversity of Mount Sinai’s patient population. “We have women from the affluent Upper East Side of Manhattan, from the Bronx, from Harlem,” says co-principal investigator Siobhan Dolan, MD, MPH, Vice Chair for Research and Director of Genetics and Genomics, Department of Obstetrics, Gynecology and Reproductive Science, and Co-Director of the Blavatnik Family Women’s Health Research Center. “The ethnic and socioeconomic diversity of our patients means that we do a very good job of reflecting the United States population.”
The World Health Organization classifies pregnant women as at high risk for serious COVID-19-related morbidity and mortality. The Mount Sinai study was proposed in response to a CDC call for research that will bolster the very limited data now available on the effects of SARS-CoV-2. It was designed by Dr. Bergink and Elizabeth Howell, MD, MPP, who is now Chair of Obstetrics and Gynecology at the Perelman School of Medicine at the University of Pennsylvania.
“This virus will be among us for a while,” Dr. Bergink says, “and it is good to have real-life data on the effects of COVID-19, especially in vulnerable groups, like pregnant women and high-risk populations.”