Risks of COVID19 in the Pregnant Population

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.

Study Overview

• Status: Completed
• Conditions: COVID19
• Intervention / Treatment: Other: Biospecimen collection

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.

.

• Study Type: Observational
• Enrollment (Actual): 69

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women testing positive for COVID19 at any time during their pregnancy after 8 weeks gestation, with or without physical symptoms. Pregnant women with respiratory or other physical symptoms of COVID19 and uncertain or negative COVID19 test results at the onset of labor.

Infants of these women will be followed for outcomes.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: 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.
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	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the prevalence of maternal fetal transmission of COVID19	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Describe the outcomes of COVID19 positive pregnancies	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.	12 months
Understand the placental impact of COVID19 in pregnancy at various gestational ages	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.	12 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Regan N Theiler, MD, PhD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2020
• Primary Completion (Actual): October 1, 2021
• Study Completion (Actual): October 1, 2021

Study Registration Dates

• First Submitted: May 4, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (Actual): May 7, 2020

Study Record Updates

• Last Update Posted (Actual): October 22, 2021
• Last Update Submitted That Met QC Criteria: October 20, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Pregnancy; Coronavirus; COVID19; Viral infection
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 20-003251

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not sharing individual participant data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No