Comparative Effectiveness of Treating Genital Herpes Infection to Reduce Racial Disparities in the Risk of Severe Maternal Morbidity (SMM)

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: f
View:

• Kaiser Permanente Northern California Members

• Pregnant women

Locations
United States
California
Division of Research, Kaiser Permanente Northern California
RECRUITING
Oakland
Contact Information
Primary
Roxana Odouli, MSPH
Roxana.Odouli@kp.org
888.381.6818
Backup
Sannaz Keyhani, MA
Sannaz.Keyhani@kp.org
510.326.0174
Time Frame
Start Date: 2023-01-08
Estimated Completion Date: 2026-04-30
Participants
Target number of participants: 339000
Treatments
Genital herpes treated before third trimester
Pregnant women with genital herpes infection receiving treatment before the 3rd trimester.
Genital herpes treated during third trimester
Pregnant women with genital herpes infection receiving treatment during the 3rd trimester.
Genital herpes untreated
Pregnant women with untreated genital herpes infection.
Control Group
Pregnant women (controls) with neither genital herpes infection nor treatment.
Related Therapeutic Areas
Sponsors
Leads: Kaiser Permanente
Collaborators: Patient-Centered Outcomes Research Institute

This content was sourced from clinicaltrials.gov