Improving syphilis testing for pregnant women and newborns

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of two advanced diagnostic techniques, quantitative polymerase chain reaction (qPCR) and transcription-mediated amplification (TMA), for detecting the syphilis-causing bacterium Treponema pallidum in maternal and neonatal samples. It aims to enhance the accuracy of syphilis testing in accordance with the CDC's guidelines for sexually transmitted infections. Participants include pregnant individuals diagnosed with syphilis and their newborns within a specific timeframe after birth.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Southern California
  Los Angeles, California, United States Recruiting
• University of California, Los Angeles
  Los Angeles, California, United States Recruiting
• Johns Hopkins University
  Baltimore, Maryland, United States Recruiting
• Kennedy Krieger Institute
  Baltimore, Maryland, United States Recruiting
• Nationwide Children's Hospital
  Columbus, Ohio, United States Recruiting
• Baylor College of Medicine
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Irene Stafford, MD — The University of Texas Health Science Center, Houston
• Study coordinator: Irene Stafford, MD
• Email: Irene.Stafford@uth.tmc.edu
• Phone: (713) 500-6412

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.