Treating Genital Herpes Infection to Reduce Racial Disparities in the Risk of Severe Maternal Morbidity
Comparative Effectiveness of Treating Genital Herpes Infection to Reduce Racial Disparities in the Risk of Severe Maternal Morbidity (SMM)
Kaiser Permanente
339,000 participants
Jan 8, 2023
OBSERVATIONAL
Conditions
Summary
Severe Maternal Morbidity (SMM) has been associated with maternal mortality, fetal risk, and long-term maternal risk. African American (AA) women are at consistently higher risk than White women. However, factors contributing to these racial disparities are largely unknown and commonly known factors have not been able to explain them, so strategies to reduce them are absent. CDC reports that the rate of GHSV infection is 4 times higher in AA than White women. Studies have shown that pregnant women with genital herpes simplex virus (GHSV) infection are at higher risk of SMM and that treating women with GHSV using existing anti-herpes medications could reduce SMM risk. To address the question of racial disparities in SMM and examine the comparative effectiveness of treating women with GHSV infection to reduce the risk of SMM, the investigators are conducting a large cohort study with a two-stage design, combining an EMR-based cohort (Stage I) with a sub-cohort interview (Stage II) to examine the impact of confounders not available from EMR data. Based on status of GHSV and treatment, 4 cohorts of women will be established: (1) those with GHSV infection receiving treatment early in pregnancy; (2) those with GHSV infection receiving treatment later in pregnancy; (3) those with GHSV infection untreated during pregnancy; and (4) those without GHSV. Given that racial disparities in SMM present serious challenges, the study will provide much needed data to address the effectiveness of treating GHSV on reducing racial disparities in SMM.
Eligibility
Inclusion Criteria2
- Kaiser Permanente Northern California Members
- Pregnant women
Exclusion Criteria2
- Non Kaiser Permanente Northern California Members
- Non-pregnant women
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Locations(1)
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NCT05429346