Recruiting

Genital Herpes

Sponsor:

Kaiser Permanente

Code:

NCT05429346

Conditions

Genital Herpes Simplex

Maternal Morbidity

Racial Disparities

Eligibility Criteria

Sex: Female

Age: 18 - 55

Healthy Volunteers: Not accepted

Study Details

Brief 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

Study ID

NCT05429346

Start date

Jan 8, 2023

Status verified date

Apr, 2024

Completion date

Apr 30, 2026

Anticipated

Primary completion date

Jan 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 55

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Kaiser Permanente Northern California Members
  • Pregnant women

Exclusion Criteria:

  • Non Kaiser Permanente Northern California Members
  • Non-pregnant women

Study Design

Enrollment

339000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Women with SMM [ Time Frame: During labor and delivery ]

Central Contacts and Locations

Central contacts

Locations

Division of Research, Kaiser Permanente Northern California

Recruiting

Oakland, California, United States, 94312

Contacts

More Information

Sponsor

Kaiser Permanente

Last update posted

Apr 24, 2024

Last verified

Apr, 2024

Keywords

  • GHSV
  • SMM
  • Racial Disparities

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Kaiser Permanente on 2024-04-24.