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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 114 (actual)
• Sponsor: Fundacion Infant · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

This is a multi-center prospective study that aims to investigate the clinical and immunologic impact of SARS-CoV-2 infection in pregnant women and neonates. The goal is to recruit 200 SARS-CoV-2 infected pregnant women starting at 24 weeks of gestation in a neonatal network of 45.000 birth a year. Clinical data will be collected from women and neonates. Upper airways samples will be obtained from both for bio-markers investigation. Finally, maternal and umbilical cord serum and human milk will be obtained for antibody assessment.

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.

Conditions

• Covid19
• Pregnancy Related
• Neonatal Infection

Timeline

• Start date: 2020-07-10
• Primary completion: 2020-10-01
• Completion: 2020-10-01
• First posted: 2020-04-27
• Last updated: 2025-03-12

Locations

1 site across 1 country: Argentina