Modernizing Perinatal Syphilis Testing

Launched by THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER, HOUSTON · Oct 9, 2023

Keywords

ClinConnect Summary

This clinical trial is focused on improving the testing methods for syphilis, a sexually transmitted infection caused by a bacterium called Treponema pallidum. The researchers want to compare two new types of tests, called quantitative polymerase chain reaction (qPCR) and transcription-mediated amplification (TMA), to see how well they can detect this bacterium in pregnant women and their newborns. The study follows the guidelines set by the Centers for Disease Control and Prevention (CDC) to ensure safety and accuracy.

To be eligible for this trial, participants need to be pregnant women diagnosed with syphilis according to CDC guidelines, or newborns whose mothers had syphilis during pregnancy. The trial is open to all genders and is currently looking for participants. If you or someone you know is interested in joining, you can expect to undergo testing to help researchers understand the effectiveness of these new diagnostic methods. This study is important because it aims to enhance syphilis testing, which can lead to better health outcomes for mothers and their babies.

Gender

ALL

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
• • 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