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

Preterm Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04955717
• Other study ID #: HS-21-00245
• Status: Completed
• Phase: N/A
• Start date: February 24, 2021
• Est. completion date: January 31, 2023

Study information

• Verified date: May 2023
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chlamydia Infections
• Chlamydia Trachomatis Infection
• Communicable Diseases
• Gonorrhea
• Infections
• Neonatal Infection
• Premature Birth
• Preterm Birth

Intervention

Other:
• Chlamydia trachomatis and Neisseria gonorrhoeae screening using the GeneXpert
Chlamydia trachomatis and Neisseria gonorrhoeae testing using the GeneXpert

Locations

Country	Name	City	State
Botswana	DHMT Clinics	Gaborone
United States	University of Southern California	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
University of Southern California	Botswana Harvard AIDS Institute Partnership, University of California, San Diego

Countries where clinical trial is conducted

United States,  Botswana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.