Summary

Eligibility
for females ages 15 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCSD
Dates
study started
estimated completion

Description

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).

Official Title

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

Details

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.

Keywords

Chlamydia Trachomatis Infection Neonatal Infection Preterm Birth Gonorrhea chlamydia trachomatis neisseria gonorrhoeae Infection Communicable Diseases Chlamydia Infections Premature Birth Chlamydia trachomatis and Neisseria gonorrhoeae testing using the GeneXpert

Eligibility

You can join if…

Open to females ages 15 years and up

  • 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 CAN'T join 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.

Locations

  • University of Southern California accepting new patients
    Los Angeles California 90032 United States
  • DHMT Clinics accepting new patients
    Gaborone Botswana

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of Southern California
ID
NCT04955717
Study Type
Interventional
Last Updated