Covid19, Neonatal Infection, Pregnancy Related
Conditions
Brief 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.
Interventions
None listed
Sponsors
Fundacion Infant
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Pregnant women hospitalized presenting with: 1. Fever with one or more respiratory symptoms (cough, odinophagia, respiratory difficulty) 2. Diagnoses of pneumonia with no other explainable cause.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vertical transmission | 96 hours from birth | Presence of IgM in Umbilical Cord or presence of virus in human milk with infected neonate |
| Neonatal protection due to maternal antibodies | 24 weeks of gestation to birth | Presence of IgG in umbilical cord |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Increase risk of neonatal morbidity | up to 30 days of life | Respiratory distress, hypothermia, poor feeding and others |
| Increase risk of obstetric complications | Up to 14 days of hospitalization | — |
Countries
Argentina
Outcome results
None listed