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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ from 12 weeks gestational age up to 18 months after birth

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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