Risks of COVID19 in the Pregnant Population

Completed

• Conditions: COVID19
• Interventions: Other: Biospecimen collection

• Registration Number: NCT04379284
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed 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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Study Timeline

• Study First Submitted: 2020-05-04
• Study First Submitted QC: 2020-05-04
• Study First Posted: 2020-05-07
• Study Start: 2020-05-08
• Status Verified: 2021-10
• Primary Completion: 2021-10-01
• Study Completion: 2021-10-01
• Last Update Submitted: 2021-10-20
• Last Update Posted: 2021-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 69

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant women - positive COVID19 test	Biospecimen collection	Pregnant women of any gestational age 8 weeks through delivery with a positive COVID19 test, with or without physical symptoms
Pregnant women - negative or unknown COVID19 test	Biospecimen collection	Pregnant women experiencing any respiratory or other physical symptoms of COVID19 at onset of labor, with negative or uncertain COVID19 test results

Primary Outcome Measures

Name	Time	Method
Determine the prevalence of maternal fetal transmission of COVID19	12 months	Standardized testing of maternal, placental, and neonatal specimens will be used to determine presence of current infection with SARS-CoV2. Clinical RT-PCR assays will be used to determine the presence of viral RNA in all specimens.

Secondary Outcome Measures

Name	Time	Method
Describe the outcomes of COVID19 positive pregnancies	12 months	Clinical data from prenatal, intrapartum, and postpartum care will be abstracted from maternal records and correlated with neonatal outcomes. Any complications will be characterized, with comparison to the non-COVID19 control group of patients. Statistical analysis will reveal characteristics and clinical outcomes that may be linked to COVID19 infection in pregnancy.
Understand the placental impact of COVID19 in pregnancy at various gestational ages	12 months	In addition to maternal and fetal infection, disease states related to placental dysfunction may be related to COVID19 infection in pregnancy. We will examine placenta and markers of placental function to assess for discernable consequences of maternal infection.

Trial Locations

Locations (1)

Mayo Clinic Rochester; 🇺🇸 Rochester, Minnesota, United States