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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04921241
Acronym
PROSPER
Enrollment
86
Registered
2021-06-10
Start date
2021-06-08
Completion date
2024-01-01
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

In Utero SARS-CoV-2 Exposure

Keywords

metabolic disease, cardiovascular disease

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.

Interventions

OTHERIn Utero Exposure to SARS-CoV-2

Born to mother with SARS-CoV-2 infection during pregnancy

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
9 Months to No maximum
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

Design outcomes

Primary

MeasureTime frame
Aortic pulse-wave velocityBaseline

Secondary

MeasureTime frame
Weight-for-length z-scoreBaseline
Systolic and diastolic blood pressureBaseline
Beta index of aortic stiffness using echocardiogramBaseline
Aortic intima-media thickness using echocardiogramBaseline
Skinfold thicknesses (subscapular, triceps)Baseline
Urinary angiotensin converting enzyme (ACE) levelsBaseline
Left ventricular massBaseline
Left ventricular dimensionsBaseline
Urinary angiotensin peptide levelsBaseline

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026