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OpenTrials
Completed

NCT Number: NCT04921241

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

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.

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Key information

Age range

9 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

In Utero Exposure to SARS-CoV-2

Other

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

Primary outcomes

  1. Aortic pulse-wave velocity

    Time frame: Baseline

Secondary outcomes

  1. Skinfold thicknesses (subscapular, triceps)

    Time frame: Baseline

  2. Weight-for-length z-score

    Time frame: Baseline

  3. Systolic and diastolic blood pressure

    Time frame: Baseline

  4. Beta index of aortic stiffness using echocardiogram

    Time frame: Baseline

  5. Aortic intima-media thickness using echocardiogram

    Time frame: Baseline

  6. Urinary angiotensin peptide levels

    Time frame: Baseline

  7. Urinary angiotensin converting enzyme (ACE) levels

    Time frame: Baseline

  8. Left ventricular mass

    Time frame: Baseline

  9. Left ventricular dimensions

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Acronym: PROSPER

Important dates

Study start
2021
Primary completion
2022
Study completion
2024
First posted
Jun 10, 2021
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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