🌐 EnglishEN

AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

Performance, Acceptability, and Usability of a Novel Rapid Lateral Flow Test for Detecting Neisseria Gonorrhoeae in Pregnant and Symptomatic Women Attending Clinics in South Africa.

Recruitingn/aAges 18 Years - anyFemaleFoundation for Professional Development (Pty) Ltd
NCT07530406 on ClinicalTrials.gov ↗
💬

In plain words

What the trial is, and whether it could suit you

Previous studies of the Neisseria gonorrhoeae (NG) lateral flow assay (LFA) have shown promising results. In East London, South Africa, the LFA demonstrated a sensitivity of 80% in asymptomatic women. However, a study in Zimbabwe reported a lower sensitivity of 65% among pregnant women attending antenatal care (ANC). This discrepancy raises important questions about the test's performance in pregnant women in the East London ANC population. Physiological changes during pregnancy may influence test accuracy, highlighting the need for further investigation in this specific population and setting. This study aims to evaluate the performance, acceptability, and usability of the NG LFA among pregnant and symptomatic women attending clinics in East London. Participants will provide clinical samples that are tested using both the NG LFA and standard laboratory methods to assess diagnostic accu

Sign in to get the eligibility rules as simple questions to take to your doctor.

Sign in
📋 Eligibility rules (as published)
Inclusion Criteria: ANC population * Women age ≥18 years * Pregnant women * Attending a study site for antenatal care * Willingness to participate and signed informed consent form (ICF) Exclusion Criteria: * Self-reported use of antimicrobial therapy within 21 days preceding enrolment * Use of vaginal douche or vaginal product in the previous 24 hours * Unable to provide specimens for testing * A medical condition, serious illness, or other condition that could interfer with study procedures or jeopardise participant safety Symptomatic population Inclusion - * Non pregnant women age ≥18 years * Diagnosis of VDS. Diagnosis of VDS will be based on self-reported presence ofsymptoms consistent with VDS, such as increased or abnormal vaginal discharge * Willingness to participate and sign ICF Exclusion - * Self-reported use of antimicrobial therapy within 21 days preceding enrolment * Use of vaginal douche or vaginal product in the previous 24 hours * Unable to provide specimens for testing * A medical condition, serious illness, or other condition that could interfere with study procedures or jeopardise participant safety
💊

What it tests

  • Novel Lateral Flow Assay for Neisseria gonorrhoeae
📍

Where

1 site
1. Nontyatyambo CHC 2. Empilweni Gompo CHC 3. Duncan Village Day Hospital 4. Grey Gateway Clinic 5. Ndevana Clinic
East London, South Africa
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy