NCT04446611Completed
Clinical Study of STI Screening to Prevent Adverse Birth and New-born Outcomes (Philani Ndiphile)
Clinical Study of STI Screening to Prevent Adverse Birth and New-born Outcomes
Source: ClinicalTrials.gov · Last updated 17 Jul 2026
Brief summary (registry, in English)
This study aims to evaluate different screening strategies to decrease the burden of Neisseria gonorrhoeae (NG), Chlamydia trachomatis (CT) and Trichomonas vaginalis (TV) among pregnant women, and reduce adverse birth outcomes. In turn it aims to evaluate the cost per pregnant woman screened and treated, cost of adverse birth outcomes, and cost-effectiveness per sexually transmitted infection (STI) and disability-adjusted life-year (DALY) averted. Furthermore, this study will incorporate a vaginal microbiome sub-study aimed to investigate the relationship between the vaginal microbiome and persistent Chlamydial infections in pregnant women. Aim 1 and 2: The intervention includes diagnostic testing at a woman's first antenatal care visit using the Xpert® platform with same-day treatment for Neisseria gonorrhoeae, Chlamydia trachomatis and Trichomonas vaginalis infection with either a test-of-cure three weeks post-treatment (arm 1) or a repeat test at 30-34 weeks gestation (arm 2) compared to the standard of care, i.e. syndromic management (arm 3). Aim 3: Case-control study to investigate role vaginal microbiome in STI treatment outcomes
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 2247 (actual)
- First submitted
- 15 Apr 2020
- Start date
- 29 Mar 2021
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- Foundation for Professional Development (Pty) Ltd
- Diseases
- HIV
- NCT number
- NCT04446611
What you commit to
- Study type: Interventional
- Participants enrolled: 2247
- From 29 Mar 2021 to the primary completion date, 31 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Unknown HIV status (e.g. refusal, invalid test result)
Lab values
- Currently participating in another ANC/HIV study
- When the ultrasound confirms ≥27 weeks gestation at first ANC
Other
- Planning to relocate during pregnancy or deliver in an MOU outside of BCM
Who the study is looking for
- Age≥18 years
- Currently pregnant based on positive urine pregnancy test
- Attending first ANC visit for current pregnancy
- Gestational age \<20 weeks (Amended to \<27 weeks, after 328 participants (14%) had been enrolled, to mitigate COVID-19 delays and align with similar studies)
- Agreeing to nurse-collected specimens
- Resident in Buffalo City Municipality (BCM)
- Intent to deliver in one of the four midwife obstetric units (MOUs) in BCM
- Gestational age will be confirmed via ultrasound
- 1\) born to mothers that provided informed consent to participate in study, 2) provision of updated verbal consent by mother to collect and test specimens for STIs
Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Buffalo City Metro Coordinator of this site? Confirm its status | East London | South Africa | Unknown status |
Related publications
- Clinician-observed genital lesions among pregnant women in a high HIV/sexually transmitted infection prevalence setting.Int J STD AIDS · 2026 · PMID 42715544
This page is information, not medical advice. Discuss any trial with your doctor.