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

May 8, 2023 updated by: Jeffrey D Klausner, University of Southern California

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Botswana
      • Gaborone, Botswana
        • DHMT Clinics
  • United States
    • California
      • Los Angeles, California, United States, 90032
        • University of Southern California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Testing and treatment
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
Chlamydia trachomatis and Neisseria gonorrhoeae testing using the GeneXpert
No Intervention: Standard of care
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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neonatal Chlamydia trachomatis or Neisseria gonorrhoeae infection
Time Frame: This outcome will be assessed at the first postnatal care visit prior to four weeks after delivery.
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
Time Frame: This outcome will be assessed at the first postnatal care visit prior to four weeks after delivery.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

University of California, San Diego
Botswana Harvard AIDS Institute Partnership

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2021

Primary Completion (Actual)

January 31, 2023

Study Completion (Actual)

January 31, 2023

Study Registration Dates

First Submitted

June 29, 2021

First Submitted That Met QC Criteria

June 29, 2021

First Posted (Actual)

July 9, 2021

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-21-00245

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD will be shared with other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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