Congenital and Maternal Point of Care Rapid Testing for Syphilis Study, Uganda
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age14+
SponsorSt George's, University of London
About this trial
Syphilis is an infection which affects about 1 in 25 pregnant women in Uganda. If the infection is not diagnosed and treated this can be a risk to the mother and unborn baby's health. This study aims to see whether a new test for syphilis infection in mothers and babies which can give a result in 10 minutes is as good as the standard tests that are done in the laboratory and take hours or days to provide results.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Mothers delivering at Kawempe National Referral Hospital with a positive syphilis rapid diagnostic test during their current pregnancy.
Disqualifiers
Mothers who are unable to give written informed consent.
Mothers with evidence of neurological symptoms compatible with neurological syphilis.
Mothers who are aged less than 14 years. Emancipated and mature minors are allowed to consent for research per Ugandan law.11
Mothers, who in the view of the study team, are unable to adhere to required study procedures
Trial population
Mothers delivering at Kawempe National Referral Hospital with a positive syphilis rapid diagnostic test during their current pregnancy.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Primary outcomes
Correlation of binary non-treponemal IgM and IgG results for the Chembio DPP Syphilis TnT with RPR positivity. Correlation of binary treponemal IgM and IgG results for the Chembio DPP Syphilis TnT with Treponemal Antibody (TPAB) positivity. Correlation of binary IgA and IgM results for the Chembio DPP Syphilis CS and Chembio DPP Syphilis TnT to the RPR results in mother and baby to confirm the diagnosis of congenital syphilis in the neonate.
Time frame
At enrolmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
St George's, University of London
Lead sponsor
Johns Hopkins University
Collaborator
MU-JHU CARE
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: