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Diagnostic Test

Diagnostic Tests for Syphilis in Pregnancy

N/A
Recruiting
Led By Irene Stafford, MD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 12 weeks gestational age up to 18 months after birth
Awards & highlights

Study Summary

This trial tests two methods to diagnose syphilis caused by Treponema pallidum in pregnant mothers and newborns.

Who is the study for?
This trial is for newborns up to 72 hours old from pregnancies impacted by syphilis and mothers diagnosed with syphilis per CDC guidelines, treated or not. It includes pregnant women at least 12 weeks along or within 96 hours postpartum. Those planning to move away before testing ends or without a true syphilis diagnosis are excluded.Check my eligibility
What is being tested?
The study tests two molecular diagnostic techniques, qPCR and TMA, for detecting the bacterium causing syphilis in maternal and neonatal specimens. These methods are compared against the CDC's STI Treatment Guidelines for diagnosing adult and congenital syphilis.See study design
What are the potential side effects?
Since this trial involves diagnostic testing rather than medication or interventions that act on the body, there are no direct side effects associated with the procedures being tested.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 12 weeks gestational age up to 18 months after birth
This trial's timeline: 3 weeks for screening, Varies for treatment, and from 12 weeks gestational age up to 18 months after birth for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the receiver operating characteristic (ROC) curve of Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidum
Area under the receiver operating characteristic (ROC) curve of CDC 2021 STI Treatment Guidelines for diagnosis of syphilis
Area under the receiver operating characteristic (ROC) curve of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum
+12 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Molecular testing for detection of T. pallidum and use of CDC guidelines for diagnosis of syphilisExperimental Treatment3 Interventions

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,965 Previous Clinical Trials
2,671,873 Total Patients Enrolled
The University of Texas Health Science Center, HoustonLead Sponsor
904 Previous Clinical Trials
320,036 Total Patients Enrolled
1 Trials studying Syphilis
24 Patients Enrolled for Syphilis
Irene Stafford, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
3 Previous Clinical Trials
417 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the magnitude of participants for this experiment?

"Affirmative. Clinicaltrials.gov indicates that this research initiative, initially published on May 2nd 2023, is currently recruiting participants. 924 individuals from nine separate medical facilities are needed for the trial to be completed."

Answered by AI

Are there currently opportunities to join this research trial?

"Historical information on clinicaltrials.gov reveals that this trial was first advertised on May 2nd 2023 and has recently been modified as of October 9th 2023. The study is actively seeking out participants for participation in the research."

Answered by AI

How many settings are involved in administering this clinical trial?

"University of California, Los Angeles in Baltimore, Maryland; Johns Hopkins University in Columbus, Ohio; and Kennedy Krieger Institute in Houston, Texas are some of the locations recruiting patients for this study. There are also 9 additional sites available."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Modernizing Perinatal Syphilis Testing
Irene Stafford 2023. "Modernizing Perinatal Syphilis Testing". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06082453.
~616 spots leftby Nov 2027
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