N/A
Completed N=500
Antenatal Chlamydia Trachomatis and Neisseria Gonorrhoeae Testing to Prevent Adverse Neonatal Consequences
Source: ClinicalTrials.gov NCT04955717 ↗Enrolled (actual)
500
Serious AEs
6.2%
Results posted
Feb 2025
Primary outcomePrimary: Number of Women Diagnosed With C. Trachomatis and N. Gonorrhoeae Infection at Post-delivery — 2; 23 Participants
Summary
To assess the effectiveness of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) testing and treatment during pregnancy to reduce adverse pregnancy and birth outcomes compared to the standard of care (treatment based on symptoms and signs).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Women Diagnosed With C. Trachomatis and N. Gonorrhoeae Infection at Post-delivery |
2; 23 | — |
| SECONDARY Number of Neonates Diagnosed With Chlamydia Trachomatis or Neisseria Gonorrhoeae Infection at Post-delivery. |
7; 3 | — |
Eligibility Criteria
Inclusion Criteria
- Age ≥ 15 years,
- Currently pregnant,
- Attending first ANC visit,
- 27 weeks gestation or less
- Not currently experiencing CT/NG-related symptoms (determined by validated screening tool),
- Not treated for CT/NG in the past 30 days,
- Willingness to provide self-collected specimens for CT/NG testing (for the STI-testing group, this will take place at their first ANC visit, at another visit in their third trimester, and at postnatal care. For the standard of care group, samples will only be collected at postnatal care),
- Willingness to return for a test of cure if CT/NG test is positive during antenatal care,
- Will reside in Gaborone through the time of delivery and 1st postnatal visit,
- Willingness to have neonates tested for CT/NG at their first postnatal visit,
- Mentally competent to understand the informed consent.
Exclusion Criteria
- Not mentally competent to understand study procedures or give informed consent,
- Individuals 27 weeks gestation
- Pregnant women with current STI-related symptoms (will receive standard of care),
- Treated for an STI in the past 30 days.
Data sourced from ClinicalTrials.gov (NCT04955717). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.