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

Primary Purpose

Chlamydia Trachomatis Infection, Neonatal Infection, Preterm Birth

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Chlamydia trachomatis and Neisseria gonorrhoeae screening using the GeneXpert
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Chlamydia Trachomatis Infection focused on measuring chlamydia trachomatis, neisseria gonorrhoeae

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Southern California
  • DHMT Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Testing and treatment

Standard of care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Preterm birth
We will compare the number of preterm births between the two arms

Full Information

First Posted
June 29, 2021
Last Updated
May 8, 2023
Sponsor
University of Southern California
Collaborators
Botswana Harvard AIDS Institute Partnership, University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT04955717
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 24, 2021 (Actual)
Primary Completion Date
January 31, 2023 (Actual)
Study Completion Date
January 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
Collaborators
Botswana Harvard AIDS Institute Partnership, University of California, San Diego

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chlamydia Trachomatis Infection, Neonatal Infection, Preterm Birth, Gonorrhea
Keywords
chlamydia trachomatis, neisseria gonorrhoeae

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Testing and treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Chlamydia trachomatis and Neisseria gonorrhoeae screening using the GeneXpert
Intervention Description
Chlamydia trachomatis and Neisseria gonorrhoeae testing using the GeneXpert
Primary Outcome Measure Information:
Title
Neonatal Chlamydia trachomatis or Neisseria gonorrhoeae infection
Description
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.
Time Frame
This outcome will be assessed at the first postnatal care visit prior to four weeks after delivery.
Secondary Outcome Measure Information:
Title
Preterm birth
Description
We will compare the number of preterm births between the two arms
Time Frame
This outcome will be assessed at the first postnatal care visit prior to four weeks after delivery.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90032
Country
United States
Facility Name
DHMT Clinics
City
Gaborone
Country
Botswana

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No IPD will be shared with other researchers
Citations:
PubMed Identifier
35255814
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.
Results Reference
derived

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

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