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

February 27, 2024 updated by: Lindsay Fourman, MD, Massachusetts General Hospital
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

86

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

We are recruiting mothers who had COVID-19 during pregnancy and their offspring (9-24 months old). We are also recruiting mothers who were at risk for but not infected with COVID-19 during pregnancy and their children to serve as controls. Mothers in both arms had been contemporaneously enrolled in the MGH COVID-19 Perinatal Biorepository during pregnancy.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
SARS-CoV-2 Exposed Dyads
Mothers who had SARS-CoV-2 during pregnancy and their offspring
SARS-CoV-2 Unexposed Dyads
Mothers who were not known to have SARS-CoV-2 during pregnancy and their offspring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Aortic pulse-wave velocity
Time Frame: Baseline
Baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Skinfold thicknesses (subscapular, triceps)
Time Frame: Baseline
Baseline
Weight-for-length z-score
Time Frame: Baseline
Baseline
Systolic and diastolic blood pressure
Time Frame: Baseline
Baseline
Beta index of aortic stiffness using echocardiogram
Time Frame: Baseline
Baseline
Aortic intima-media thickness using echocardiogram
Time Frame: Baseline
Baseline
Urinary angiotensin peptide levels
Time Frame: Baseline
Baseline
Urinary angiotensin converting enzyme (ACE) levels
Time Frame: Baseline
Baseline
Left ventricular mass
Time Frame: Baseline
Baseline
Left ventricular dimensions
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2021

Primary Completion (Actual)

September 28, 2022

Study Completion (Actual)

January 1, 2024

Study Registration Dates

First Submitted

June 7, 2021

First Submitted That Met QC Criteria

June 7, 2021

First Posted (Actual)

June 10, 2021

Study Record Updates

Last Update Posted (Actual)

February 29, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2021P001107

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on In Utero SARS-CoV-2 Exposure

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Denmark

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe