Antenatal Chlamydia Trachomatis and Neisseria Gonorrhoeae Testing to Prevent Adverse Neonatal Con… (NCT04955717) | Clinical Trial Compass
CompletedNot Applicable
Antenatal Chlamydia Trachomatis and Neisseria Gonorrhoeae Testing to Prevent Adverse Neonatal Consequences
United States, Botswana500 participantsStarted 2021-02-24
Plain-language 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).
Who can participate
Age range15 Years
SexFEMALE
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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 \< 15 years,
* Men,
* Women who are not pregnant,
* Pregnant women not attending their first antenatal visit,
* Pregnant women at \>27 weeks gestation
* Pregnant women with current STI-related symptoms (will receive standard of care),
* Treated for an STI in the past 30 days.
What they're measuring
1
Number of Women Diagnosed With C. Trachomatis and N. Gonorrhoeae Infection at Post-delivery
Timeframe: This outcome was assessed at the first postnatal care visit up to 12 weeks after delivery.