In Utero Exposure to SARS-CoV-2 (COVID-19) and Cardiovascular and Metabolic Endpoints in Early Life
- Conditions
- In Utero SARS-CoV-2 Exposure
- Registration Number
- NCT04921241
- Lead Sponsor
- Massachusetts General Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 86
- Mother with or without prenatal COVID-19 who was enrolled in the MGH COVID-19 Perinatal Biorepository and her child (9-24 months old)
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Aortic pulse-wave velocity Baseline
- Secondary Outcome Measures
Name Time Method 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 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
Trial Locations
- Locations (1)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Massachusetts General Hospital🇺🇸Boston, Massachusetts, United States