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Risks of COVID19 in the Pregnant Population

NCT ID: NCT04379284

Last Updated: 2021-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

69 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-08

Study Completion Date

2021-10-01

Brief Summary

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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.

Detailed Description

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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.

.

Conditions

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COVID19

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Pregnant women - positive COVID19 test

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

Biospecimen collection

Intervention Type OTHER

Maternal blood, vaginal swab, and anorectal swab will be obtained at the time of enrollment prior to delivery. A sample of breastmilk before hospital discharge and again at six weeks postpartum will be obtained if the mother is lactating.

Neonatal specimens collected following delivery will include placental tissue, fetal membrane roll, umbilical cord tissue, umbilical cord blood, and an anorectal swab.

Pregnant women - negative or unknown COVID19 test

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

Biospecimen collection

Intervention Type OTHER

Maternal blood, vaginal swab, and anorectal swab will be obtained at the time of enrollment prior to delivery. A sample of breastmilk before hospital discharge and again at six weeks postpartum will be obtained if the mother is lactating.

Neonatal specimens collected following delivery will include placental tissue, fetal membrane roll, umbilical cord tissue, umbilical cord blood, and an anorectal swab.

Interventions

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Biospecimen collection

Maternal blood, vaginal swab, and anorectal swab will be obtained at the time of enrollment prior to delivery. A sample of breastmilk before hospital discharge and again at six weeks postpartum will be obtained if the mother is lactating.

Neonatal specimens collected following delivery will include placental tissue, fetal membrane roll, umbilical cord tissue, umbilical cord blood, and an anorectal swab.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Regan N. Theiler

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Regan N Theiler, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

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20-003251

Identifier Type: -

Identifier Source: org_study_id