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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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The Diagnosis and Treatment of Chlamydia Trachomatis and Neisseria Gonorrhoeae in Pregnant Women to Prevent Adverse Neonatal Consequences.

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

Intervention / Treatment
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* Other: Chlamydia trachomatis and Neisseria gonorrhoeae screening using the GeneXpert


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Clinic randomized trial evaluating the effectiveness of antenatal CT and NG screening and treatment compared to the standard of care (treatment based on signs and symptoms) on pregnancy and neonatal outcomes.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Testing and treatment<br>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. | Other: Chlamydia trachomatis and Neisseria gonorrhoeae screening using the GeneXpert<br>* Chlamydia trachomatis and Neisseria gonorrhoeae testing using the GeneXpert<br>|
| No Intervention: Standard of care<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal Chlamydia trachomatis or Neisseria gonorrhoeae infection | Infants of mothers who tested positive Chlamydia trachomatis or Neisseria gonorrhoeae infection at the first postnatal care visit will be tested. We will compare the number of infected neonates between two arms. | This outcome will be assessed at the first postnatal care visit prior to four weeks after delivery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preterm birth | We will compare the number of preterm births between the two arms | This outcome will be assessed at the first postnatal care visit prior to four weeks after delivery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chlamydia trachomatis, neisseria gonorrhoeae