Point-Of-Care Testing for Congenital Syphilis in Mothers and Newborns

NCT03814096 | Withdrawn FDA Device

• 1 other identifier: 49086
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

A dramatic rise in syphilis has been recently reported in the US between 2000-2017, which was followed also by a dramatic rise in congenital syphilis (CS). In 2017 there were 918 CS cases reported in the United States, including 64 syphilitic stillbirths. In 2017, California (CA) had one of the highest syphilis rates among women and this was accompanied by a dramatic increase in CS cases. Approximately 40% of CS cases in the United States occurred from maternal infections acquired late in gestation, missed by current-early gestation only-prenatal screening. More frequent prenatal screening late in gestation is urgently needed. However, cost considerations and operational logistic limitations preclude implementation even in high risk regions. There is an urgent need for widespread implementation of more frequent prenatal screening using alternative cost-saving screening approaches. The Syphilis-Health-Check (SHC) point-of-care (POC) test is a well validated POC-test that is already commercially available in the US, is approved by the Federal Drug Administration (FDA) and Clinical Laboratory Improvement Amendments (CLIA)-waived. POC prenatal syphilis screening late in gestation using a well validated POC-test (in addition to the standard early gestation-screening with laboratory-based tests) could provide a cost-saving complementary alternative that could benefit patients, mitigate the higher cost associated with more frequent testing, overcome operational limitations and contribute to the elimination of CS. Moreover, POC-neonatal and placental screening could provide an additional complementary safeguard approach to decrease missed/delayed CS diagnoses.

Conditions

Maternal Syphilis During Pregnancy - Baby Not Yet Delivered; Congenital Syphilis

Keywords

Syphilis, prenatal screening, SHC, point-of-care test

Outcome Measures

Primary Outcomes (3)

• Count of pregnant women with concordant test results between the SHC-POC test and the TT/NTT test at 24-28 weeks gestational age, as a measure of validation of the diagnostic accuracy of the SHC-POC-test

  Diagnostic accuracy of SHC-POC test against standard laboratory diagnostic tests for syphilis (TT/NTT) in late gestation (24-28 weeks)

  Between 24-28 weeks gestational age of study participants

• Count of pregnant women with concordant test results between the SHC-POC test and maternal syphilis diagnosis at 24-28 weeks gestational age requiring treatment during gestation, as a measure of validation of the diagnostic accuracy of the SHC-POC test

  Diagnostic accuracy of SHC-POC test against maternal syphilis diagnosis late in gestation requiring treatment during gestation (24-28 weeks)

  Between 24-28 weeks gestational age of study participants

• Incidence of Congenital Syphilis (N of congenital Syphilis cases/ N of total births), as a measure of efficacy of POC-prenatal syphilis screening at 24-28 weeks gestational age

  The efficacy of SHC-POC prenatal screening in decreasing the incidence of Congenital Syphilis will be calculated. Comparison will be made between the incidence rate of Congenital Syphilis cases before the SHC-POC-prenatal screening (among all births in Santa Clara Valley Medical Center, San Jose, CA in the year before the SHC-POC-prenatal screening) and 3 years after the implementation of the SHC POC-prenatal screening (among all births from the screened participating pregnant women)

  At birth and up to 3 months of age of offsprings of study participants

Secondary Outcomes (1)

• Count of concordant SHC-POC-test results between maternal, placental and neonatal SHC-POC-testing.

  At 24-28 weeks gestational age of study participants (for maternal POC-test results); During Delivery (for placental POC-test results) and at birth and up to 3 months of age of offsprings of study participants (for neonatal POC-test results)

Study Arms (1)

Syphilis POC-prenatal screening

EXPERIMENTAL

Syphilis prenatal screening late in gestation at 24-28 weeks (at the time of the routine prenatal care clinic visit for the routine Glucose Tolerance Test \[GTT\]) using the Syphilis Health Check POC-test (Diagnostics Direct LLC, NJ)

Diagnostic Test: Syphilis Health Check POC-test (Diagnostics Direct LLC, NJ)

Interventions

Syphilis Health Check POC-test (Diagnostics Direct LLC, NJ) DIAGNOSTIC_TEST

Syphilis Health Check (SHC) POC-test is a treponemal POC-test based on 3d generation enzyme immunoassay (EIA) method detecting both Immunoglobulin G (IgG) and Immunoglobulin M (IgM) antibodies.

Syphilis POC-prenatal screening

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consenting adult pregnant women between 24-28 weeks GA seen at Obstetrics/Gynecology (OB/GYN) prenatal-care clinics in Santa Clara Valley Medical Center San Jose CA, at the time of their routine clinic visit at 24-28 weeks GA for their routine glucose-tolerance-test (GTT) prenatal screening.

You may not qualify if:

• Non-adult pregnant patients \<18 years of age and pregnant women not between 24-28 weeks gestational age at the time of the clinic visit.

Sponsors & Collaborators

• Stanford University: lead
• Santa Clara Valley Medical Center: collaborator

Study Sites (2)

Santa Clara Valley Medical Center; Department of Obstetrics & Gynecology and Pediatrics

San Jose, California, 95128, United States

Location

Stanford University School of Medicine, Department of Pediatrics, Division of Infectious Diseases

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Syphilis, Congenital; Syphilis

Condition Hierarchy (Ancestors)

Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases

Study Officials

• Despina G. Contopoulos-Ioannidis, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor, Department of Pediatrics, Division of Infectious Diseases, Stanford University School of Medicine

Study Record Dates

• First Submitted: January 18, 2019
• First Posted: January 23, 2019
• Study Start: October 30, 2019
• Primary Completion: October 29, 2022
• Study Completion: October 29, 2023
• Last Updated: December 13, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: The data will become available within 2 years from the completion of the study and will stay available.
• Access Criteria: The informed consent forms and the database with the completely de-identified patient data (without any Personal Health Information (PHI)) will become available upon request from the study Principal Investigator.

Locations

US (2)