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COVID-19 Testing for Pregnancy (STOPCOVID19 Trial)
N/A
Waitlist Available
Led By Megan E Foeller, MD
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at time of delivery
Summary
This trial aims to understand how COVID-19 affects pregnant women by checking their health and observing their well-being over time. It will help improve testing strategies and prenatal care plans to better support pregnant women during the pandemic.
Who is the study for?
This trial is for pregnant women without prior SARS-CoV-2 infection (unexposed group) and those with a viable pregnancy who have tested positive or developed antibodies during their current pregnancy (exposed group). Women with no viable intrauterine pregnancy or evidence of previous COVID-19 immunity are excluded.
What is being tested?
The study tests for the presence of SARS-CoV-2 through RNA, IgM, and IgG antibody testing in pregnant women. It aims to understand the necessity of asymptomatic disease testing in pregnancy and its impact on prenatal care plans.
What are the potential side effects?
Since this trial involves diagnostic testing rather than medication or vaccines, direct side effects from interventions are minimal but may include discomfort or bruising from blood draws.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time of delivery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time of delivery
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Rate of preterm delivery
Secondary study objectives
Confirmed congenital infection
Low birth weight
Percentage of infants with abnormal umbilical cord gas
+15 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: Exposed (SARS-CoV-2 positive) cohortActive Control2 Interventions
Women who experience laboratory-confirmed SARS-CoV-2 infection during pregnancy.
Group II: Unexposed (SARS-CoV-2 negative) cohortPlacebo Group1 Intervention
Women who do not experience laboratory-confirmed SARS-CoV-2 infection during pregnancy.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Coronavirus Infection, such as COVID-19, include antiviral medications, corticosteroids, and supportive care. Antiviral medications, like remdesivir, work by inhibiting the replication of the virus, thereby reducing the viral load in the body.
Corticosteroids, such as dexamethasone, help reduce inflammation and modulate the immune response, which can prevent severe complications like acute respiratory distress syndrome (ARDS). Supportive care, including oxygen therapy and hydration, helps manage symptoms and maintain vital functions.
These treatments are crucial for COVID-19 patients as they can reduce the severity of the disease, improve recovery times, and decrease mortality rates. Understanding these mechanisms is particularly important for managing high-risk populations, such as pregnant women, where tailored care and early intervention can significantly impact outcomes.
A bibliometric analysis of research related Chinese Medicine in the prevention and treatment of corona virus disease 2019.Recent discovery and development on SARS-CoV-2: A review of current literature.COVID-19: clinical issues from the Japan Surgical Society.
A bibliometric analysis of research related Chinese Medicine in the prevention and treatment of corona virus disease 2019.Recent discovery and development on SARS-CoV-2: A review of current literature.COVID-19: clinical issues from the Japan Surgical Society.
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Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,997 Previous Clinical Trials
2,298,341 Total Patients Enrolled
1 Trials studying Coronavirus Infection
30 Patients Enrolled for Coronavirus Infection
Mercy ResearchOTHER
20 Previous Clinical Trials
1,007 Total Patients Enrolled
Megan E Foeller, MDPrincipal InvestigatorWashington University School of Medicine