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

University of Southern California

Status: Completed

Conditions: Gonorrhea; Chlamydia Trachomatis Infection; Neonatal Infection; Preterm Birth

Treatments: Other: Chlamydia trachomatis and Neisseria gonorrhoeae screening using the GeneXpert

Study type: Interventional

Funder types: Other

Identifiers

NCT04955717

HS-21-00245

Details and patient eligibility

About

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).

Full description

In this study investigators are conducting a two-arm, cluster randomized trial 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). Investigators will enroll 500 asymptomatic pregnant women in the testing and treatment clinics, and they will receive CT and NG testing and appropriate treatment at their first antenatal care visit and at a visit during their third trimester. An additional 250 asymptomatic pregnant women will be enrolled in the standard of care clinics, and they will receive syndromic management with additional support for partner notification. All participants will be tested for CT and NG at the first postnatal visit and those who test positive will be offered infant testing. Investigators will determine if antenatal testing and treatment reduces maternal infections at delivery, preterm birth, low birth weight, and neonatal CT/NG infection. This study will provide evidence to help evaluate the effects of testing on vertical transmission and clinically important pregnancy neonatal health outcomes, and to evaluate and understand biological correlates of transmission.

Enrollment: 500 patients

Sex: Female

Ages: 15+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Testing and treatment

Experimental group

Description:

Participants will receive CT and NG testing and treatment (if necessary) at their first antenatal care visit and a visit during their third trimester. Women will also receive support for partner notification. All women will receive postnatal testing and treatment. Those who test positive at the postnatal visit will be offered infant testing.

Treatment:

Other: Chlamydia trachomatis and Neisseria gonorrhoeae screening using the GeneXpert

Standard of care

No Intervention group

Description:

Participants will receive the standard of care for STI management, which is treatment based on signs and symptoms. Women will also receive support for partner notification. All women will receive postnatal testing and treatment. Those who test positive at the postnatal visit will be offered infant testing.