An observational study in Covid19, Pregnancy Related and Neonatal Infection, sponsored by Fundacion Infant. Completed at 1 site in Argentina. Open to female participants. Per ClinicalTrials.gov, last updated 2025-03-12.
Sponsored by Fundacion Infant · Observational
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.
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 114 is below the median of 240 across 2,136 observational studies indexed under Infections.
Browse Infections studies →Fundacion Infant is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Elegible patients will be all pregnant women of 9 large maternity hospitals in Argentina.
Pregnant women hospitalized presenting with:
Exclusion Criteria:
Vertical transmission
Presence of IgM in Umbilical Cord or presence of virus in human milk with infected neonate
Time frame: 96 hours from birth
Neonatal protection due to maternal antibodies
Presence of IgG in umbilical cord
Time frame: 24 weeks of gestation to birth
Increase risk of neonatal morbidity
Respiratory distress, hypothermia, poor feeding and others
Time frame: up to 30 days of life
Increase risk of obstetric complications
Time frame: Up to 14 days of hospitalization
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Fundacion Infant