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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Vertical transmission | Presence of IgM in Umbilical Cord or presence of virus in human milk with infected neonate | 96 hours from birth |
| Neonatal protection due to maternal antibodies | Presence of IgG in umbilical cord | 24 weeks of gestation to birth |
| Measure | Description | Time Frame |
|---|---|---|
| Increase risk of neonatal morbidity | Respiratory distress, hypothermia, poor feeding and others | up to 30 days of life |
| Increase risk of obstetric complications | Up to 14 days of hospitalization |
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Inclusion Criteria:
Pregnant women hospitalized presenting with:
Exclusion Criteria:
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Elegible patients will be all pregnant women of 9 large maternity hospitals in Argentina.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Italiano | Buenos Aires | 1420 | Argentina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34865064 | Derived | Larcade R, DeShea L, Lang GA, Caballero MT, Ferretti A, Beasley WH, Tipple TE, Vain N, Prudent L, Lang ML, Polack FP, Ofman G. Maternal-Fetal Immunologic Response to SARS-CoV-2 Infection in a Symptomatic Vulnerable Population: A Prospective Cohort. J Infect Dis. 2022 Mar 2;225(5):800-809. doi: 10.1093/infdis/jiab591. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Nasopharyngeal aspirates Maternal serum Umbilical Cord serum Human milk
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |