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

NCT ID: NCT04921241

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

86 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-08

Study Completion Date

2024-01-01

Brief Summary

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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

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Conditions

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In Utero SARS-CoV-2 Exposure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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SARS-CoV-2 Exposed Dyads

Mothers who had SARS-CoV-2 during pregnancy and their offspring

In Utero Exposure to SARS-CoV-2

Intervention Type OTHER

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

No interventions assigned to this group

Interventions

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In Utero Exposure to SARS-CoV-2

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

9 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lindsay Fourman, MD

Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2021P001107

Identifier Type: -

Identifier Source: org_study_id

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