Chlamydia Trachomatis InfectionNCT04955717
Antenatal Chlamydia Trachomatis and Neisseria Gonorrhoeae Testing to Prevent Adverse Neonatal Consequences
A study testing Chlamydia trachomatis and Neisseria gonorrhoeae screening using the GeneXpert in people with Chlamydia Trachomatis Infection and Neonatal Infection, run by University of Southern California at 2 sites in 2 countries.
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). Read more about this study
- Who is it for?
- Ages 15 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chlamydia Trachomatis Infection, Neonatal Infection, Preterm Birth
- What is being tested?
- Chlamydia trachomatis and Neisseria gonorrhoeae screening using the GeneXpert
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 24 Feb 2021to 31 Jan 2023
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
University of Southern California
Los Angeles, California, 90032
About this study
Official title: 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).
Read the 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.
- Being tested
- Chlamydia trachomatis and Neisseria gonorrhoeae screening using the GeneXpert
- Keywords
- chlamydia trachomatis, neisseria gonorrhoeae
- Medical subject headings
- Premature Birth, Gonorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlamydia trachomatis and Neisseria gonorrhoeae screening using the GeneXpertOther
Chlamydia trachomatis and Neisseria gonorrhoeae testing using the GeneXpert
| Study group | Role | What they receive |
|---|---|---|
| Testing and treatment | Experimental | 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. Receives: Other: Chlamydia trachomatis and Neisseria gonorrhoeae screening using the GeneXpert |
| Standard of care | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Number of Women Diagnosed With C. Trachomatis and N. Gonorrhoeae Infection at Post-delivery
Results from GeneXpert PCR screening for Chlamydia trachomatis (CT) or Neisseria gonorrhoeae (NG) infection among postpartum women up 12 weeks after birth outcome. We compare the proportion with CT and/or NG in both study arms
Measured: This outcome was assessed at the first postnatal care visit up to 12 weeks after delivery.
Secondary outcomes (1)
Number of Neonates Diagnosed With Chlamydia Trachomatis or Neisseria Gonorrhoeae Infection at Post-delivery.
Infants of mothers who tested positive for Chlamydia trachomatis or Neisseria gonorrhoeae infection at the first postnatal care visit will be tested using the GeneXpert PCR. We will compare the number of infected neonates between two arms.
Measured: This outcome will be assessed at the first postnatal care visit up to 12 weeks after delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start24 Feb 2021
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chlamydia Trachomatis InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Botswana Harvard AIDS Institute Partnership, University of California, San Diego
- Responsible party
- Principal investigator, Jeffrey D Klausner, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955717
- Sponsor's protocol ID
- HS-21-00245
- Status last verified
- Jan 2025
- First submitted
- 29 Jun 2021
- Last updated
- 3 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared with other researchers
Publications
Mussa A, Wynn A, Ryan R, Babalola CM, Hansman E, Simon S, Bame B, Moshashane N, Masole M, Wilson ML, Klausner JD, Morroni C. Effect of antenatal Chlamydia trachomatis and Neisseria gonorrhoeae screening on postdelivery prevalence and vertical transmission in Gaborone, Botswana: findings from an exploratory study. Sex Transm Infect. 2025 Mar 24;101(2):81-87. doi: 10.1136/sextrans-2023-055965.
PubMed 39366745Wynn 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.
PubMed 35255814