Safety, Testing/Transmission, and Outcomes in Pregnancies With COVID-19
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Coronavirus
- COVID-19
- Maternal Complication of Pregnancy
- Neonatal Infection
- Pregnancy Related
- Prenatal Stress
- Preterm Birth
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This is a prospective study that will 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. Outcomes will be compared between the two cohorts.Masking: None (Open Label)Primary Purpose: Diagnostic
Participation Requirements
- Age
- Younger than 125 years
- Gender
- Only males
Description
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) e...
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.
Tracking Information
- NCT #
- NCT04718220
- Collaborators
- Mercy Research
- Investigators
- Principal Investigator: Megan E Foeller, MD Washington University School of Medicine
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