Clinical and Immunologic Impact of SARS-CoV-2 in Hospitalized Pregnant Women and Neonates in Argentina
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Covid19
- Sponsor
- Fundacion Infant
- Enrollment
- 114
- Locations
- 1
- Primary Endpoint
- Vertical transmission
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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
- Not provided
Outcomes
Primary Outcomes
Vertical transmission
Time Frame: 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
Time Frame: 24 weeks of gestation to birth
Presence of IgG in umbilical cord
Secondary Outcomes
- Increase risk of obstetric complications(Up to 14 days of hospitalization)
- Increase risk of neonatal morbidity(up to 30 days of life)