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OpenTrials
Completed

NCT Number: NCT04362956

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

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Neonatal Infection Nidovirales Infections Pneumonia Pneumonia, Viral Pregnancy Related RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Hospital Italiano

Buenos Aires, 1420, Argentina

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • None

Treatment and study plan

Primary outcomes

  1. Vertical transmission

    Time frame: 96 hours from birth

    Presence of IgM in Umbilical Cord or presence of virus in human milk with infected neonate

  2. Neonatal protection due to maternal antibodies

    Time frame: 24 weeks of gestation to birth

    Presence of IgG in umbilical cord

Secondary outcomes

  1. Increase risk of neonatal morbidity

    Time frame: up to 30 days of life

    Respiratory distress, hypothermia, poor feeding and others

  2. Increase risk of obstetric complications

    Time frame: Up to 14 days of hospitalization

Sponsors and collaborators

Lead sponsor

Fundacion Infant

Other

Registry information

Official study title

Clinical and Immunologic Impact of SARS-CoV-2 in Hospitalized Pregnant Women and Neonates in Argentina

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 27, 2020
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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