Pregnant women are a vulnerable and high-risk population, as COVID-19 is associated with an increased risk preterm birth, cesarean section, and maternal critical care. This study will examine the factors that impede testing for SARS-CoV-2 (the causative virus among pregnant women), help determine optimal testing strategies by evaluating the necessity of testing for asymptomatic disease in pregnancy, inform prenatal care plans by assessing the full impact of infection, and contribute to a provider's ability to counsel women and create prenatal care plans if they are pregnant or considering pregnancy.
Pregnant women are a vulnerable and high-risk population, as COVID-19 is associated with an
increased risk of preterm birth, cesarean section, and maternal intensive care. The
objectives of this study are to: (a) evaluate the full impact of SARS-CoV-2 in pregnancy to
inform testing strategies, (b) examine the factors that impede testing during pregnancy, and
(c) use study data to devise implementation strategies that improve SARS-CoV-2 testing in
pregnancy and prenatal care during the pandemic. Investigators will prospectively enroll two
cohorts of pregnant women: 1) exposed (SARS-CoV-2 positive), and 2) unexposed (SARS-CoV-2
negative as defined by antibody testing at the beginning of pregnancy, every trimester, and
at delivery). Women who initially enroll as unexposed but later test positive for SARS-CoV-2
antibodies will cross over to the exposed cohort. In Aim 1, investigators will evaluate
patients' and providers' perceptions of SARS-CoV-2 testing during pregnancy and the influence
of COVID-19 on maternal care-seeking behavior and anxiety via surveys and semi-structured
interviews. In Aim 2, investigators will determine the effect of SARS-CoV-2 infection during
pregnancy on the risk of preterm birth and other adverse pregnancy outcomes in symptomatic
and asymptomatic disease. It is hypothesized that SARS-CoV-2 infection will increase the risk
of preterm birth by 12%. In Aim 3, investigators will estimate the risk of mother-to-fetus
SARS-CoV-2 transmission and viral presence in umbilical cord blood, placenta, and amniotic
fluid by assaying for viral RNA in the neonate, cord blood, and placenta. Collectively, Aims
1-3 will be interpreted by investigators, the Scientific Advisory Board and the Community
Advisory Board who will apply data to devising targeted implementation strategies designed
for rapid community dissemination to improve testing and prenatal care.
Diagnostic Test: Antibody testing for SARS-CoV-2 IgG
Women enrolled into the unexposed (SARS-CoV-2 negative) cohort will undergo testing for SARS-CoV-2 IgG antibodies at enrollment, every trimester of pregnancy, and during delivery hospitalization.
Diagnostic Test: Testing for SARS-CoV-2 RNA
Women in the exposed (SARS-CoV-2 positive) cohort will undergo testing of placental tissue, umbilical cord blood, amniotic tissue, and neonates for SARS-CoV-2 RNA, as available.
Diagnostic Test: Testing for SARS-CoV-2 IgM/IgG
Women in the exposed (SARS-CoV-2 positive) cohort will undergo testing of umbilical cord blood for SARS-CoV-2 IgG and IgM antibodies, as available.
Inclusion Criteria for exposed (SARS-CoV-2 positive) cohort:
- Viable intrauterine pregnancy
- Seroconversion or SARS-CoV-2 IgG antibodies or positive RT-PCR for SARS-CoV-2 during
current pregnancy
Exclusion Criteria for exposed (SARS-CoV-2 positive) cohort:
- No viable intrauterine pregnancy
- No history of SARS-CoV-2 infection during pregnancy
Inclusion Criteria for unexposed (SARS-CoV-2 negative) cohort:
- Viable intrauterine pregnancy
- No history of SARS-CoV-2 infection prior to pregnancy
Exclusion Criteria for unexposed (SARS-CoV-2 negative) cohort:
- No viable intrauterine pregnancy
- Detection of SARS-CoV-2 IgG antibodies at enrollment
Washington University Medical Center
Saint Louis, Missouri, United States
Megan E Foeller, MD, Principal Investigator
Washington University School of Medicine