Pregnant women are a vulnerable and high-risk population, as COVID-19 is associated withan increased risk preterm birth, cesarean section, and maternal critical care. This studywill examine the factors that impede testing for SARS-CoV-2 (the causative virus amongpregnant women), help determine optimal testing strategies by evaluating the necessity oftesting for asymptomatic disease in pregnancy, inform prenatal care plans by assessingthe full impact of infection, and contribute to a provider's ability to counsel women andcreate 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