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Purpose

Since its initial outbreak in late 2019, coronavirus disease 2019 (COVID-19) caused by the novel coronavirus SARS-CoV-2 has ravaged the globe, causing illness characterized by inflammation and impaired oxygen levels. As a particularly vulnerable group, pregnant women have had a heightened prevalence and severity of infection. In this context, a new population of children has emerged who were exposed to maternal COVID-19 in the womb. As maternal diseases during pregnancy may impact the health of offspring over the life course, health outcomes among these individuals must be urgently evaluated. In the current study, the investigators will leverage a perinatal biorepository comprised of pregnant women with and without COVID-19 to delineate the metabolic and cardiovascular risk profiles of these offspring. This work stands to benefit the burgeoning population of children exposed to COVID-19 in the womb and to deepen the mechanistic understanding of developmental origins of cardiometabolic disease with respect to maternal infections.

Condition

Eligibility

Eligible Ages
Over 9 Months
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Mother with or without prenatal COVID-19 who was enrolled in the MGH COVID-19 Perinatal Biorepository and her child (9-24 months old)

Exclusion Criteria

  • Child with any history of documented COVID-19 - Mother who received the COVID-19 vaccine during pregnancy with her child - Significant chronic illness in mother or child judged by the investigator to represent a contraindication to study participation

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross-Sectional

Arm Groups

ArmDescriptionAssigned Intervention
SARS-CoV-2 Exposed Dyads Mothers who had SARS-CoV-2 during pregnancy and their offspring
  • Other: In Utero Exposure to SARS-CoV-2
    Born to mother with SARS-CoV-2 infection during pregnancy
SARS-CoV-2 Unexposed Dyads Mothers who were not known to have SARS-CoV-2 during pregnancy and their offspring

Recruiting Locations

More Details

NCT ID
NCT04921241
Status
Completed
Sponsor
Massachusetts General Hospital

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.