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

NCT05429346 | Recruiting

• 1 other identifier: 1873689
• Study Type: observational
• Target: 339,000
• Locations: 1 country
• Sites: 1

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

Keywords

GHSV; SMM; Racial Disparities

Outcome Measures

Primary Outcomes (1)

• Women with SMM

  SMM Diagnoses based on CDC's list of 21 indicators

  During labor and delivery

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All KPNC pregnant women during the study period will be eligible for the study.

You may qualify if:

• Kaiser Permanente Northern California Members
• Pregnant women

You may not qualify if:

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

Sponsors & Collaborators

• Kaiser Permanente: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Division of Research, Kaiser Permanente Northern California

Oakland, California, 94312, United States

RECRUITING

MeSH Terms

Conditions

Herpes Genitalis

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; Herpes Simplex; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases

Study Officials

• De-Kun Li, MD, PhD

  Division of Research, Kaiser Permanente Northern California

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roxana Odouli, MSPH

CONTACT

888.381.6818; Roxana.Odouli@kp.org

Sannaz Keyhani, MA

CONTACT

510.326.0174; Sannaz.Keyhani@kp.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: June 23, 2022
• Study Start: January 8, 2023
• Primary Completion: January 31, 2025
• Study Completion: April 30, 2026
• Last Updated: April 24, 2024

Record last verified: 2024-04

Locations

US (1)