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Clinical Trials/NCT04921241
NCT04921241
Completed
Not Applicable

In Utero Exposure to SARS-CoV-2 (COVID-19) and Cardiovascular and Metabolic Endpoints in Early Life

Massachusetts General Hospital1 site in 1 country86 target enrollmentJune 8, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
In Utero SARS-CoV-2 Exposure
Sponsor
Massachusetts General Hospital
Enrollment
86
Locations
1
Primary Endpoint
Aortic pulse-wave velocity
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
June 8, 2021
End Date
January 1, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lindsay Fourman, MD

Assistant Professor of Medicine

Massachusetts General Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Aortic pulse-wave velocity

Time Frame: Baseline

Secondary Outcomes

  • Beta index of aortic stiffness using echocardiogram(Baseline)
  • Urinary angiotensin peptide levels(Baseline)
  • Urinary angiotensin converting enzyme (ACE) levels(Baseline)
  • Aortic intima-media thickness using echocardiogram(Baseline)
  • Left ventricular dimensions(Baseline)
  • Left ventricular mass(Baseline)
  • Skinfold thicknesses (subscapular, triceps)(Baseline)
  • Weight-for-length z-score(Baseline)
  • Systolic and diastolic blood pressure(Baseline)

Study Sites (1)

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