- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04362956
Clinical and Immunologic Impact of Perinatal SARS-CoV-2 (COVID-19) Infection
Clinical and Immunologic Impact of SARS-CoV-2 in Hospitalized Pregnant Women and Neonates in Argentina
Study Overview
Status
Conditions
Detailed Description
COVID-19, the disease caused by the novel coronavirus SARS-CoV-2, has led to an unprecedented global pandemic affecting persons of all ages. Pregnant women are in a physiologic immunosuppressed situation and have a greater risk and severity of respiratory infection. However, considerable uncertainty exists regarding the potential for vertical transmission (prenatal/congenital or perinatal) of SARS-CoV-2 from infected pregnant women to their newborns and its potential clinical consequences.
This study attempts to provide evidence-based guidelines for managing antenatal, intrapartum, and neonatal care around COVID-19 require an understanding of whether the virus can be transmitted transplacentally; a determination of which maternal body fluids may be infectious; trasnplacental and human milk antibody transfer and data of adequate statistical power that describe which maternal, intrapartum, and neonatal factors influence perinatal transmission.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Buenos Aires, Argentina, 1420
- Hospital Italiano
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Pregnant women hospitalized presenting with:
- Fever with one or more respiratory symptoms (cough, odinophagia, respiratory difficulty)
- Diagnoses of pneumonia with no other explainable cause.
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vertical transmission
Time Frame: 96 hours from birth
|
Presence of IgM in Umbilical Cord or presence of virus in human milk with infected neonate
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96 hours from birth
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Neonatal protection due to maternal antibodies
Time Frame: 24 weeks of gestation to birth
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Presence of IgG in umbilical cord
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24 weeks of gestation to birth
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Increase risk of neonatal morbidity
Time Frame: up to 30 days of life
|
Respiratory distress, hypothermia, poor feeding and others
|
up to 30 days of life
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Increase risk of obstetric complications
Time Frame: Up to 14 days of hospitalization
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Up to 14 days of hospitalization
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Perinatal COVID-19
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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