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

Completed

• Conditions: In Utero SARS-CoV-2 Exposure
• Interventions: Other: In Utero Exposure to SARS-CoV-2

• 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

Study Timeline

• Study First Submitted: 2021-06-07
• Study First Submitted QC: 2021-06-07
• Study Start: 2021-06-08
• Study First Posted: 2021-06-10
• Primary Completion: 2022-09-28
• Study Completion: 2024-01-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SARS-CoV-2 Exposed Dyads	In Utero Exposure to SARS-CoV-2	Mothers who had SARS-CoV-2 during pregnancy and their offspring

Primary Outcome Measures

Name	Time	Method
Aortic pulse-wave velocity	Baseline

Secondary Outcome Measures

Name	Time	Method
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
Beta index of aortic stiffness using echocardiogram	Baseline

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States