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Treating Genital Herpes Infection to Reduce Racial Disparities in the Risk of Severe Maternal Morbidity

NCT05429346 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 339000

Last updated 2024-04-24

No results posted yet for this study

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.

Conditions

  • Genital Herpes Simplex
  • Maternal Morbidity
  • Racial Disparities

Sponsors & Collaborators

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER

  • Kaiser Permanente

    lead OTHER

Principal Investigators

  • De-Kun Li, MD, PhD · Division of Research, Kaiser Permanente Northern California

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-08
Primary Completion
2025-01-31
Completion
2026-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05429346 on ClinicalTrials.gov