Improving syphilis testing for pregnant women and newborns
Modernizing Perinatal Syphilis Testing
This study is testing two new ways to improve syphilis testing for pregnant women and their newborns to make sure they get the right care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 924 (estimated) |
| Ages | N/A to 45 Years |
| Sex | All |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 9 sites (Los Angeles, California and 8 other locations) |
| Trial ID | NCT06082453 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include pregnant individuals diagnosed with syphilis and their newborns within 72 hours of birth.
Not a fit: Patients who do not have a diagnosis of syphilis or those who are planning to move outside the study area prior to testing may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and timely diagnosis of syphilis in pregnant women and their infants, ultimately improving health outcomes.
How similar studies have performed: Other studies have shown promise in improving syphilis testing methods, but this specific approach using qPCR and TMA is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
Los Angeles, California and 8 other locations
- 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)
- Texas Children's Hospital — Houston, Texas, United States (Recruiting)
- The University of Texas Health Science Center at Houston — Houston, Texas, United States (Recruiting)
- Christus Health — 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.