Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
FEMALE
ID06645106

Offering Routine and Rapid Point of Care Syphilis Testing in Pregnant Patients Presenting to the Emergency Department

Led by The University of Texas Health Science Center, Houston · Updated on 2026-05-06

1500

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to improve syphilis screening and treatment in pregnant patients who come to the emergency department or obstetrical triage without prenatal care or documented syphilis test results during their current pregnancy. It evaluates whether offering routine lab-based and rapid point of care (POC) syphilis testing along with a strong follow-up care program can increase the rates of full treatment for all stages of syphilis. The study also looks at social and healthcare factors like poverty, insurance, and health literacy that might affect treatment completion and health equity. Participants will receive a rapid POC syphilis test using a handheld device that analyzes a small blood sample from a finger stick, providing results within about 10 minutes. Positive results will be recorded in the medical record, and the care team and health department will be notified for timely treatment. This study focuses on pregnant patients without prenatal care or syphilis test documentation during pregnancy, aiming to link them to care effectively. Participants will be followed from the time of testing until delivery and up to 15 months postpartum to assess treatment completion and adherence to recommended maternal and newborn follow-up care. Researchers will collect data on social factors, prenatal visits, reinfection rates, and cases of congenital syphilis. The main outcomes include the percentage of patients who receive full treatment within one week of presentation and maintain follow-up through delivery and postpartum. The study runs until February 2028 and is sponsored by The University of Texas Health Science Center, Houston.

CONDITIONS

Brief Title

Offering Routine and Rapid Point of Care (POC) Syphilis Testing in Pregnant Patients Presenting to the Emergency Department

Who Can Participate

Age: 18Years - 50Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant individuals seeking care at University of Texas, Memorial Herman, and Lyndon B Johnson emergency departments or obstetrical triage units
  • No prenatal care during the current pregnancy
  • No documented syphilis test results during the current pregnancy
Not Eligible

You will not qualify if you...

  • Pregnant individuals with documented prenatal care and syphilis test results during the current pregnancy for the specific trimester as required by Texas law

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants undergo rapid point of care syphilis testing using a handheld device that provides results within 10 minutes. Testing is performed by research staff using a finger stick blood sample.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 15 months postpartum

Participants are monitored for adherence to recommended maternal and newborn follow-up care, syphilis treatment completion, and health and social factors from presentation until delivery and up to 15 months postpartum.

Follow-up visits as part of routine care up to delivery and postpartum

Trial Site Locations

Total: 1 location

1

The University of Texas Health Science Center at Houston

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

I

Irene Stafford, MD

C

Carrie Bakunas, MD

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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