Actively Recruiting

Phase Not Applicable
Age: 0 - 45Years
All Genders
NCT06082453

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

Age: 0 - 45Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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Modernizing Perinatal Syphilis Testing | DecenTrialz