Federal grant · project grant (b)
Long Term Adverse Health Outcomes for Women and Children Following SARS-COV-2 Infection During Pregnancy - Project Summary Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2) Infection, the Virus Responsible for the Global COVID-19 Pandemic of Unprecedented Scale Causes a Multi-organ Disease With Widespread Effects. Increasing Evidence Suggests Long-term Effects of SARS-COV-2 Infection in Some Individuals Present Up to a Year After Initial Infection, Referred to as Post-acute Sequelae of SARS-COV-2 (pasc). Pregnant Women and Their Fetuses May Be Particularly Vulnerable to the Long-term Effects of SARS-COV-2 Infection. the Biological Plausibility and Emerging Epidemiological Evidence From SARS-COV-2 Infections in the Population Highlight the Urgent Need for Research on the Long-term Effects of SARS-COV-2 Infection During Pregnancy on Women’s Cardiometabolic and Neuropsychiatric Health Outcomes and Children’s Growth and Development. Limitations of Current Studies of Both Pregnant Women With SARS-COV-2 Infection and Their Children Exposed in Utero, Include a Lack of Long-term Follow-up, Lack of Data on Pre-existing Conditions Making It Difficult to Disentangle Risk Factors for the Infection From Its Consequences, and Limited Ability to Examine Associations by Predominant SARS-COV-2 Variant and Vaccination Status. the Proposed Study Leverages Kaiser Permanente Northern California’s (kpnc’s) High-quality Electronic Health Records (EHR) Data on SARS-COV-2 Infection Testing and Results to Assemble a Longitudinal Pregnancy Cohort of >195,000 Pregnant Women (>22,000 Women With SARS-COV-2 Infection During Pregnancy and APPROXIMATELY>173,000 Without) Between March 2020 and December 2022. We Will Use Our Robust and Comprehensive Ehr to Follow Women and Their Children for Up to 5 Years and Ascertain Clinical Diagnoses Data. Additionally, We Will Recruit and Survey a Subsample of 2000 of the Mother-child Dyads When the Child Is 3 Years Old to Ascertain Women’s and Children’s Self/parent-reported Subclinical Health Outcomes Not Available in the Ehr, But That May Suggest a Need to Monitor And/or Provide Early Interventions. We Will Randomly Identify 1000 Dyads With SARS-COV-2 Infection During Pregnancy (1/3 Early Variants, 1/3 Delta and 1/3 Omicron Variants) and 1000 Dyads Without SARS-COV-2 Infection During Pregnancy. Our Study Will Assess the Following: 1) Evaluate the Long-term Effects of a SARS-COV-2 Infection During Pregnancy on Women’s Cardiometabolic and Neuropsychiatric Outcomes (ehr and Self-report), and 2) Evaluate the Long-term Effects of in Utero Exposure to SARS-COV-2 Infection on Child Growth Trajectory and Neurodevelopment (ehr and Parent-report). We Will Examine Variant, Severity of Infection and Gestational Age at Infection in Relation to All Outcomes of Interest and Explore Effect Modification by Vaccination Status, Race/ethnicity and Pre-existing Co-morbidities. Finally, Our Analyses Will Include Infection Status Before, During and After Pregnancy or Birth Allowing for Estimation of Joint Effects. This Project Will Fill a Significant Gap Informing Women and Children Exposed to SARS-COV-2 Infection During Pregnancy, the Public, Clinicians, and Health Care Systems of the Full Spectrum of Health Consequences of Infection.
Committed
$2.4 Million
Paid out
$2.0M
82%
Committed, not yet paid
$428.2K
18%
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