In Utero SARS-CoV-2 ExposurePROSPERNCT04921241
In Utero Exposure to SARS-CoV-2 (COVID-19) and Cardiovascular and Metabolic Endpoints in Early Life
An observational study of In Utero SARS-CoV-2 Exposure, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 months and olderHealthy volunteers can take part
- Conditions the study is for
- In Utero SARS-CoV-2 Exposure
- What is being tested?
- In Utero Exposure to SARS-CoV-2
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2021to 1 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Mother with or without prenatal COVID-19 who was enrolled in the MGH COVID-19 Perinatal Biorepository and her child (9-24 months old)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
- Conditions
- In Utero SARS-CoV-2 Exposure
- Being tested
- In Utero Exposure to SARS-CoV-2
- Keywords
- metabolic disease, cardiovascular disease
- Medical subject headings
- Metabolic Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In Utero Exposure to SARS-CoV-2Other
Born to mother with SARS-CoV-2 infection during pregnancy
| Study group | Role | What they receive |
|---|---|---|
| SARS-CoV-2 Exposed Dyads | Mothers who had SARS-CoV-2 during pregnancy and their offspring Receives: Other: In Utero Exposure to SARS-CoV-2 | |
| SARS-CoV-2 Unexposed Dyads | Mothers who were not known to have SARS-CoV-2 during pregnancy and their offspring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aortic pulse-wave velocity
Measured: Baseline
Secondary outcomes (9)
Skinfold thicknesses (subscapular, triceps)
Measured: Baseline
Weight-for-length z-score
Measured: Baseline
Systolic and diastolic blood pressure
Measured: Baseline
Beta index of aortic stiffness using echocardiogram
Measured: Baseline
Aortic intima-media thickness using echocardiogram
Measured: Baseline
Urinary angiotensin peptide levels
Measured: Baseline
Urinary angiotensin converting enzyme (ACE) levels
Measured: Baseline
Left ventricular mass
Measured: Baseline
Left ventricular dimensions
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start8 Jun 2021
- Primary completion28 Sep 2022
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for In Utero SARS-CoV-2 ExposureStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lindsay Fourman, MD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04921241
- Sponsor's protocol ID
- 2021P001107
- Acronym
- PROSPER
- Status last verified
- Sep 2024
- First submitted
- 7 Jun 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Utero Exposure to SARS-CoV-2 (COVID-19) and Cardiovascular and Metabolic Endpoints in Early Life
- ClinicalTrials.gov ID
- NCT04921241
- Acronym / sponsor ID
- PROSPER / 2021P001107
- Conditions
- In Utero SARS-CoV-2 Exposure
- Keywords
- metabolic disease, cardiovascular disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 8 Jun 2021 (actual)
- Primary completion
- 28 Sep 2022 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 10 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SARS-CoV-2 Exposed Dyads | – | Other: In Utero Exposure to SARS-CoV-2Mothers 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 |
Who may qualify
- Ages
- 9 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Mother with or without prenatal COVID-19 who was enrolled in the MGH COVID-19 Perinatal Biorepository and her child (9-24 months old)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In Utero Exposure to SARS-CoV-2Born to mother with SARS-CoV-2 infection during pregnancy | Other | SARS-CoV-2 Exposed Dyads |
Primary outcome
Aortic pulse-wave velocity
Time frame: Baseline
9 secondary outcomes
Skinfold thicknesses (subscapular, triceps)
Time frame: Baseline
Weight-for-length z-score
Time frame: Baseline
Systolic and diastolic blood pressure
Time frame: Baseline
Beta index of aortic stiffness using echocardiogram
Time frame: Baseline
Aortic intima-media thickness using echocardiogram
Time frame: Baseline
Urinary angiotensin peptide levels
Time frame: Baseline
Urinary angiotensin converting enzyme (ACE) levels
Time frame: Baseline
Left ventricular mass
Time frame: Baseline
Left ventricular dimensions
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of In Utero SARS-CoV-2 Exposure, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aortic pulse-wave velocity (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.