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

F

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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