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Modernizing Perinatal Syphilis Testing

Modernizing Perinatal Syphilis Testing

Recruiting
45 years and younger
All
Phase N/A

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Overview

Treponema pallidum is a bacterium that causes the disease syphilis. The primary objective of the study is to evaluate the testing performance of two diagnostic molecular techniques [quantitative polymerase chain reaction (qPCR) and transcription-mediated amplification (TMA)] for the detection of Treponema pallidum in maternal and neonatal specimens from participants with the diagnosis of syphilis using the Centers for Disease Control's (CDC's) Sexually Transmitted Infections (STI) Treatment Guidelines for adult and congenital syphilis.

Eligibility

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
  • Neonates of pregnancies affected by syphilis ≤ 72 hours of birth

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

Study details
    Syphilis

NCT06082453

The University of Texas Health Science Center, Houston

28 January 2024

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