Modernizing Perinatal Syphilis Testing
Recruiting now · Not applicable
Conditions studied: Syphilis
In brief
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.
Key facts
- Study ID
- NCT06082453
- Run by
- The University of Texas Health Science Center, Houston
- People needed
- 924
- Starts
- 2023-05-02
- Expected to finish
- 2027-11-30
- Last updated by the study team
- 2025-11-03
Who can join
Age: any, up to 45. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Pregnant individuals and neonates who do not meet the criteria of syphilis (false positive)
- Planning to move outside of study prior to ND testing
Where it is running
- University of Southern California — Los Angeles, California, United States (enrolling)
- University of California, Los Angeles — Los Angeles, California, United States (enrolling)
- Johns Hopkins University — Baltimore, Maryland, United States (enrolling)
- Kennedy Krieger Institute — Baltimore, Maryland, United States (enrolling)
- Nationwide Children's Hospital — Columbus, Ohio, United States (enrolling)
- Baylor College of Medicine — Houston, Texas, United States (enrolling)
- Texas Children's Hospital — Houston, Texas, United States (enrolling)
- The University of Texas Health Science Center at Houston — Houston, Texas, United States (enrolling)
- Christus Health — Houston, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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