Home › Syphilis › NCT06082453
Modernizing Perinatal Syphilis Testing
Recruiting
Who can join
Up to age 45 · All sexes
Full 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
About the study
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.
What is being tested
- 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 (diagnostic test)
- Center for Disease Control (CDC) Sexually Transmitted Infections (STI) 2021 Treatment Guidelines for diagnosis of syphilis (other)
Sponsor: The University of Texas Health Science Center, Houston · Participants: 924 · Started: May 2, 2023
Contact the study team
- Irene Stafford, MD · Phone: (713) 500-6412
Official record on ClinicalTrials.gov — NCT06082453
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.