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

Completed

• Conditions: Covid19; Neonatal Infection; Pregnancy Related

• Registration Number: NCT04362956
• Lead Sponsor: Fundacion Infant

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.

Study Timeline

• Study First Submitted: 2020-04-21
• Study First Submitted QC: 2020-04-23
• Study First Posted: 2020-04-27
• Study Start: 2020-07-10
• Primary Completion: 2020-10-01
• Study Completion: 2020-10-01
• Status Verified: 2021-02
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 114

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Increase risk of obstetric complications	Up to 14 days of hospitalization
Increase risk of neonatal morbidity	up to 30 days of life	Respiratory distress, hypothermia, poor feeding and others

Trial Locations

Locations (1)

Hospital Italiano; 🇦🇷 Buenos Aires, Argentina