NCT06082453NARecruiting

Modernizing Perinatal Syphilis Testing

The University of Texas Health Science Center, Houston

Start Date

5/2/2023

Completion Date

11/30/2027

Summary

The purpose of this study is to determine the testing performance of real-time quantitative polymerase chain reaction and transcription mediated amplification by comparing test performance of these novel molecular tests to current 2021 CDC CS guidelines for maternal/neonatal dyads at risk for syphilis infection and to determine whether CS is associated with adverse neurodevelopmental outcomes.

Eligibility Criteria

Age Range: No minimum to 45 years

Inclusion Criteria: * Maternal diagnosis of syphilis by 2021 CDC STI guidelines, irrespective of treatment status; AND viable pregnancy with gestational age ≥ 12 weeks OR postpartum ≤ 96 hours from delivery OR Neonates of pregnancies affected by syphilis ≤ 72 hours of birth * Individuals (men and non-pregnant) with syphilis in Harris Health clinic with syphilis Exclusion Criteria: * Pregnant individuals and neonates who do not meet the criteria of syphilis (false positive) * Planning to move outside of study prior to ND testing

Interventions

DIAGNOSTIC_TEST

Quantitative polymerase chain reaction (qPCR) assay for detection of Treponema pallidum

DIAGNOSTIC_TEST

Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detection of Treponema pallidum

OTHER

Center for Disease Control (CDC) Sexually Transmitted Infections (STI) 2021 Treatment Guidelines for diagnosis of syphilis

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Conditions

Syphilis

Locations

University of Southern California

Los Angeles, California 90007

United States

University of California, Los Angeles

Los Angeles, California 90095

United States

Johns Hopkins University

Baltimore, Maryland 21205

United States

Kennedy Krieger Institute

Baltimore, Maryland 21205

United States

Nationwide Children's Hospital

Columbus, Ohio 43205

United States

Baylor College of Medicine

Houston, Texas 77030

United States

Texas Children's Hospital

Houston, Texas 77030

United States

The University of Texas Health Science Center at Houston

Houston, Texas 77030

United States

Christus Health

Houston, Texas 78130

United States