Risks of COVID19 in the Pregnant Population

  • STATUS
    Recruiting
  • participants needed
    100
  • sponsor
    Mayo Clinic
Updated on 19 February 2024
respiratory symptom

Summary

It is unclear how COVID19 can be passed from mother to infant. The study investigators aim to collect maternal and neonatal samples from COVID19-infected pregnant women and compare them to pregnant women who have clinical indications for COVID 19 testing at the time of hospital admission but end up being COVID19 negative. Pregnant women who are either COVID19 positive or COVID19 negative with respiratory symptoms will be enrolled and followed during this study.

Description

The objectives are to understand the prevalence of maternal fetal transmission, risk factors and outcomes of a COVID19 positive pregnancy, and how the virus can be passed from mother to infant in the pregnant population at Mayo Clinic Rochester MN. Assessments will include the viral detection and viral load in maternal and fetal specimens collected from COVID19 positive mother-baby dyads, presence of maternal and fetal inflammatory markers in blood and tissues, anti-COVID IgG and IgM in maternal and neonatal blood, viral load and viral antigens in maternal and fetal specimens. placental gross and histopathologic changes in COVID19 infected mothers, stratified by gestational age and disease severity, compared to control samples.

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Details
Condition COVID19
Age 18-45 years
Treatment Biospecimen Collection
Clinical Study IdentifierNCT04379284
SponsorMayo Clinic
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

Pregnant women ages 18 - 45 years of age and their newborn infants
Willing and able to provide written informed consent
Planning to deliver at Mayo Clinic in Rochester, MN

Exclusion Criteria

Positive for HIV, HBV, or TB
Delivery does not occur at Mayo Clinic
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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