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

NCT04955717 | Completed Results

• 1 other identifier: HS-21-00245
• Study Type: interventional
• Target: 500
• Locations: 2 countries
• Sites: 2

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).

Conditions

Chlamydia Trachomatis Infection; Neonatal Infection; Preterm Birth; Gonorrhea

Keywords

chlamydia trachomatis; neisseria gonorrhoeae

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  This outcome will be assessed at the first postnatal care visit up to 12 weeks after delivery.

Study Arms (2)

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.

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.

Interventions

Chlamydia trachomatis and Neisseria gonorrhoeae screening using the GeneXpert OTHER

Chlamydia trachomatis and Neisseria gonorrhoeae testing using the GeneXpert

Testing and treatment

Eligibility Criteria

• Age: 15 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 15 years,
• Currently pregnant,
• Attending first ANC visit,
• 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 may not qualify 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.

Sponsors & Collaborators

• University of Southern California: lead
• Botswana Harvard AIDS Institute Partnership: collaborator
• University of California, San Diego: collaborator

Study Sites (2)

University of Southern California

Los Angeles, California, 90032, United States

Location

DHMT Clinics

Gaborone, Botswana

Location

Related Publications (2)

• 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.

  PMID: 39366745 DERIVED

• 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.

  PMID: 35255814 DERIVED

MeSH Terms

Conditions

Premature Birth; Gonorrhea

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases

Results Point of Contact

• Title: Dr. Jeffrey D. Klausner
• Organization: USC

jdklausner@med.usc.edu

415-876-8901

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: July 9, 2021
• Study Start: February 24, 2021
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: February 3, 2025
• Results First Posted: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

BO (1); US (1)