Actively Recruiting
Modernizing Perinatal Syphilis Testing
Led by The University of Texas Health Science Center, Houston · Updated on 2025-11-03
924
Participants Needed
9
Research Sites
239 weeks
Total Duration
On this page
Sponsors
T
The University of Texas Health Science Center, Houston
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to determine the testing performance of real-time quantitative polymerase chain reaction and transcription mediated amplification by comparing test performance of these novel molecular tests to current 2021 CDC CS guidelines for maternal/neonatal dyads at risk for syphilis infection and to determine whether CS is associated with adverse neurodevelopmental outcomes.
CONDITIONS
Official Title
Modernizing Perinatal Syphilis Testing
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Maternal diagnosis of syphilis by 2021 CDC STI guidelines regardless of treatment
- Pregnancy with gestational age 12 weeks or more OR postpartum within 96 hours of delivery
- Neonates of pregnancies affected by syphilis within 72 hours of birth
- Men and non-pregnant individuals with syphilis at Harris Health clinic
You will not qualify if you...
- Pregnant individuals and neonates who do not meet syphilis criteria (false positives)
- Planning to move outside the study area before newborn testing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
University of Southern California
Los Angeles, California, United States, 90007
Actively Recruiting
2
University of California, Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
3
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Actively Recruiting
4
Kennedy Krieger Institute
Baltimore, Maryland, United States, 21205
Actively Recruiting
5
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
6
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
7
Texas Children's Hospital
Houston, Texas, United States, 77030
Actively Recruiting
8
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
9
Christus Health
Houston, Texas, United States, 78130
Actively Recruiting
Research Team
I
Irene Stafford, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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