Risks of COVID19 in the Pregnant Population

Mayo Clinic

Status: Completed

Conditions: COVID19

Treatments: Other: Biospecimen collection

Study type: Observational

Funder types: Other

Identifiers

NCT04379284

20-003251

Details and patient eligibility

About

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.

Full 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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Enrollment: 69 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

69 participants in 2 patient groups

Pregnant women - positive COVID19 test

Description:

Pregnant women of any gestational age 8 weeks through delivery with a positive COVID19 test, with or without physical symptoms

Treatment:

Other: Biospecimen collection

Pregnant women - negative or unknown COVID19 test

Description:

Pregnant women experiencing any respiratory or other physical symptoms of COVID19 at onset of labor, with negative or uncertain COVID19 test results

Treatment:

Other: Biospecimen collection