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NCT05429346 · ClinicalTrials.gov registry record
Treating Genital Herpes Infection to Reduce Racial Disparities in the Risk of Severe Maternal Morbidity
A clinical trial of Racial Disparities and Maternal Morbidity, sponsored by Kaiser Permanente.
- Recruiting
- Registry status
- 339,000
- Enrollment target
- 1
- Study location
NCT05429346 is a study of Racial Disparities and Maternal Morbidity that is actively recruiting participants, run by Kaiser Permanente. The registered enrollment target is 339,000 participants, above the 70-participant average among 5 other Racial Disparities trials with a reported enrollment target (484186% higher). The trial reports 1 study location across 1 state.
The verdict
NCT05429346, a study of Racial Disparities and Maternal Morbidity, is actively recruiting participants, sponsored by Kaiser Permanente.
- RECRUITING
- Registry status
- 339,000 participants
- Enrollment target
- 1
- Study location
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 Studied
Study Locations (1)
California
- Division of Research, Kaiser Permanente Northern California - Oakland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 339,000 participants |
| Start Date | 2023-01-08 |
| Est. Completion | 2026-04-30 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05429346
The ClinicalTrials.gov registry entry for NCT05429346 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 339,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 70-participant average among 5 other Racial Disparities trials with a reported enrollment target (484186% higher). The listed sponsor is Kaiser Permanente, which has 294 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Racial Disparities appearing as the primary indexed condition, and to 0 interventions.
NCT05429346 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT05429346 about?
NCT05429346 is a clinical study titled "Treating Genital Herpes Infection to Reduce Racial Disparities in the Risk of Severe Maternal Morbidity". 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...
What is the current status of trial NCT05429346?
This trial is currently recruiting. The enrollment target is 339,000 participants. The study started on 2023-01-08. Estimated completion is 2026-04-30.
What conditions does trial NCT05429346 study?
This clinical trial studies the following conditions: Racial Disparities, Maternal Morbidity, Genital Herpes Simplex.
Who is sponsoring clinical trial NCT05429346?
This trial is sponsored by Kaiser Permanente, which has 294 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05429346 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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