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OpenTrials
Completed

NCT Number: NCT04379284

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

About this study

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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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biospecimen Collection

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.

Primary outcomes

  1. Determine the prevalence of maternal fetal transmission of COVID19

    Time frame: 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 outcomes

  1. Describe the outcomes of COVID19 positive pregnancies

    Time frame: 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.

  2. Understand the placental impact of COVID19 in pregnancy at various gestational ages

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 7, 2020
Registry last updated
Oct 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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