Evaluating New Molecular Tests for Detecting Syphilis in Pregnant Women and Newborns Compared to CDC Guidelines

What this Trial Is About

Researchers are evaluating new molecular tests to detect syphilis infection in mothers and newborns. This study compares the performance of two novel tests, real-time quantitative polymerase chain reaction qPCR and transcription-mediated amplification TMA, to the current 2021 CDC guidelines for diagnosing syphilis in maternal and neonatal pairs. The study also aims to determine whether congenital syphilis is linked to adverse neurodevelopmental outcomes. The study involves collecting samples from mothers and newborns at birth to perform qPCR and TMA assays, which detect the presence of Treponema pallidum, the bacteria that causes syphilis. These molecular test results will be compared to diagnoses made using the CDC 2021 Sexually Transmitted Infections treatment guidelines, which classify newborn syphilis infection based on clinical exams, serology, and placental pathology. The molecular test data will not be used to guide clinical care but only to assess test accuracy. Participants include mothers diagnosed with syphilis during pregnancy or shortly after delivery, and their newborns within 72 hours of birth. The study measures the sensitivity, specificity, predictive values, and accuracy of the molecular tests from birth up to 96 hours or 72 hours depending on the test. The CDC guideline diagnosis is assessed from 12 weeks gestational age up to 18 months after birth. The research team will monitor results carefully to understand test performance and any links between syphilis and infant development over time.

Modernizing Perinatal Syphilis Testing