Antenatal Chlamydia Trachomatis and Neisseria Gonorrhoeae Testing to Prevent Adverse Neonatal Consequences

Completed · Not applicable

Conditions studied: Chlamydia Trachomatis Infection, Neonatal Infection, Preterm Birth, Gonorrhea

In brief

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).

Key facts

Study ID

NCT04955717

Run by

University of Southern California

People needed

500

Starts

2021-02-24

Expected to finish

2023-01-31

Last updated by the study team

2025-02-03

Who can join

Age: 15 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Southern California — Los Angeles, California, United States
• DHMT Clinics — Gaborone, Botswana

Full record on ClinicalTrials.gov

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