Clinical trial NCT04955717: Antenatal Chlamydia Trachomatis and Neisseria Gonorrhoeae Testing to Prevent Adverse Neonatal Consequences
Official title: The Diagnosis and Treatment of Chlamydia Trachomatis and Neisseria Gonorrhoeae in Pregnant Women to Prevent Adverse Neonatal Consequences.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chlamydia Trachomatis Infection
Neonatal Infection
Preterm Birth
Gonorrhea
Keywords: chlamydia trachomatis
neisseria gonorrhoeae
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Botswana Harvard AIDS Institute Partnership
name: University of California, San Diego
First posted: 2021-07-09
Enrollment: 500
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SCREENING

Brief 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).

Detailed 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.

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 \< 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.

Primary outcomes:
measure: 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.
Secondary outcomes:
measure: Number of Neonates Diagnosed With Chlamydia Trachomatis or Neisseria Gonorrhoeae Infection at Post-delivery.
timeFrame: This outcome will be assessed at the first postnatal care visit up to 12 weeks after delivery.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Gaborone
country: Botswana
facility: DHMT Clinics
Study officials:
References:
citation: Wynn A, Mussa A, Ryan R, Hansman E, Simon S, Bame B, Moreri-Ntshabele B, Ramogola-Masire D, Klausner JD, Morroni C. Evaluating the diagnosis and treatment of Chlamydia trachomatis and Neisseria gonorrhoeae in pregnant women to prevent adverse neonatal consequences in Gaborone, Botswana: protocol for the Maduo study. BMC Infect Dis. 2022 Mar 7;22(1):229. doi: 10.1186/s12879-022-07093-z.