Clinical and Immunologic Impact of Perinatal SARS-CoV-2 (COVID-19) Infection

Fundacion Infant

Status: Completed

Conditions: Pregnancy Related; Covid19; Neonatal Infection

Study type: Observational

Funder types: Other

Identifiers

NCT04362956

Perinatal COVID-19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 114 patients

Sex: Female

Volunteers: No Healthy Volunteers

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