← Back to Clinical Trials
Recruiting NCT06082453

Modernizing Perinatal Syphilis Testing

Trial Parameters

Condition Syphilis
Sponsor The University of Texas Health Science Center, Houston
Study Type INTERVENTIONAL
Phase N/A
Enrollment 924
Sex ALL
Min Age N/A
Max Age 45 Years
Start Date 2023-05-02
Completion 2027-11-30
Interventions
Quantitative polymerase chain reaction (qPCR) assay for detection of Treponema pallidumAptima Treponema pallidum transcription-mediated amplification (TMA) assay for detection of Treponema pallidumCenter for Disease Control (CDC) Sexually Transmitted Infections (STI) 2021 Treatment Guidelines for diagnosis of syphilis

Brief 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

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

Related Trials